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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505554-18-00 | Registry Identifier | CTIS | |
| 2019-004493-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease or disease progression within 6 months of starting first line treatment for metastatic disease with an endocrine therapy combined with a CDK4/6 inhibitor. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab deruxtecan | Experimental | Trastuzumab deruxtecan (T-DXd; DS-8201a) arm |
|
| Standard of Care | Active Comparator | Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | Trastuzumab deruxtecan by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population | PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. |
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Key Inclusion Criteria:
Patients must be ≥18 years of age
Pathologically documented breast cancer that:
No prior chemotherapy for advanced or metastatic breast cancer.
Has adequate tumor samples for assessment of HER2 status
Must have either:
Has protocol-defined adequate organ and bone marrow function
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85259 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39282896 | Derived | Bardia A, Hu X, Dent R, Yonemori K, Barrios CH, O'Shaughnessy JA, Wildiers H, Pierga JY, Zhang Q, Saura C, Biganzoli L, Sohn J, Im SA, Levy C, Jacot W, Begbie N, Ke J, Patel G, Curigliano G; DESTINY-Breast06 Trial Investigators. Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer. N Engl J Med. 2024 Dec 5;391(22):2110-2122. doi: 10.1056/NEJMoa2407086. Epub 2024 Sep 15. | |
| 37499870 |
| Label | URL |
|---|---|
| AZ Breast Cancer Study Navigators | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
866 participants were randomized in a 1:1 ratio to receive trastuzumab deruxtecan (T-DXd) or standard of care: Investigator's choice single agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel). As pre-specified in the protocol and statistical analysis plan (SAP), results are presented by treatment group.
This Phase III, multi-center, open-label study was conducted in participants with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor-positive (HR+) breast cancer at 273 sites in 28 countries. Results are presented based on primary completion date (PCD) of up to 18 March 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | T-DXd | Participants received T-DXd 5.4 milligram per kilogram (mg/kg) via intravenous (IV) infusion every 3 weeks until disease progression (PD), unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
| FG001 | Chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2023 | Jun 9, 2025 |
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The study consists of 2 independent open label treatment arms: trastuzumab deruxtecan and Investigator's choice chemotherapy (paclitaxel, nab-paclitaxel or capecitabine).
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This study is an open-label study that will be conducted "Sponsor-blind". To maintain the integrity of the study, Sponsor personnel directly involved in study conduct will not undertake or have access to efficacy data aggregated by treatment group prior to final data readout for the primary endpoint.
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| Capecitabine | Drug | Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally. |
|
| Paclitaxel | Drug | Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion. |
|
| Nab-Paclitaxel | Drug | Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion |
|
| From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Overall Survival (OS) in the Intent-to-Treat Population | OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | PFS per RECIST 1.1 assessed by Investigator was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population | ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population | DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiation of the study drug until the 40-day (+7 days) safety follow-up visit. | From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a | Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum. | Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91 | EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization. | Baseline (Day 1) and Week 91 |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58 | EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization. | Baseline (Day 1) and Week 58 |
| Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score | Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration. | From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan | Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration. | From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
| Time to First Subsequent Treatment or Death (TFST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | TFST was defined as time from randomization to the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause. | From Day 1 up to 64 months |
| Time to Second Subsequent Treatment or Death (TSST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | TSST was defined as time from randomization to the start date of the second subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause. | From Day 1 up to 64 months |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| Research Site | Duarte | California | 91010 | United States |
| Research Site | Los Angeles | California | 90017 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Lakewood | Colorado | 80228 | United States |
| Research Site | Washington D.C. | District of Columbia | 20016 | United States |
| Research Site | Jacksonville | Florida | 32224 | United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Bethesda | Maryland | 20817 | United States |
| Research Site | Boston | Massachusetts | 02114 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Summit | New Jersey | 07901 | United States |
| Research Site | Westbury | New York | 11590 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15212 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Houston | Texas | 77090 | United States |
| Research Site | Norfolk | Virginia | 23502 | United States |
| Research Site | Seattle | Washington | 98104 | United States |
| Research Site | Madison | Wisconsin | 53792-5666 | United States |
| Research Site | Buenos Aires | C1125ABD | Argentina |
| Research Site | CABA | 1414 | Argentina |
| Research Site | CABA | C1012AAR | Argentina |
| Research Site | CABA | C1019ABS | Argentina |
| Research Site | Ciudad de Buenos Aires | 1280 | Argentina |
| Research Site | Córdoba | 5000 | Argentina |
| Research Site | La Plata | 1900 | Argentina |
| Research Site | Mar del Plata | 7600 | Argentina |
| Research Site | Rosario | S2000DEJ | Argentina |
| Research Site | Rosario | S2002KDS | Argentina |
| Research Site | Adelaide | 5000 | Australia |
| Research Site | Birtinya | 4575 | Australia |
| Research Site | Darlinghurst | 2010 | Australia |
| Research Site | Murdoch | 6150 | Australia |
| Research Site | South Brisbane | 4101 | Australia |
| Research Site | St Leonards | 2065 | Australia |
| Research Site | Waratah | 2298 | Australia |
| Research Site | Graz | 8036 | Austria |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Anderlecht | 1070 | Belgium |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | Charleroi | 6060 | Belgium |
| Research Site | Edegem | 2650 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Liège | 4000 | Belgium |
| Research Site | Namur | 5000 | Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Sint-Niklaas | 9100 | Belgium |
| Research Site | Barretos | 14784-400 | Brazil |
| Research Site | Belo Horizonte | 30110-022 | Brazil |
| Research Site | Natal | 59075-740 | Brazil |
| Research Site | Porto Alegre | 90610-000 | Brazil |
| Research Site | Porto Alegre | 91350-200 | Brazil |
| Research Site | Rio de Janeiro | 20560-120 | Brazil |
| Research Site | São Paulo | 04038-034 | Brazil |
| Research Site | São Paulo | 1323001 | Brazil |
| Research Site | Sorocaba | 18030-510 | Brazil |
| Research Site | Calgary | Alberta | T2N 5G2 | Canada |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Toronto | CA | M5G 2M9 | Canada |
| Research Site | London | Ontario | N6A 5W9 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Toronto | Ontario | M5G 1X5 | Canada |
| Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Research Site | Baoding | 071000 | China |
| Research Site | Beijing | 100006 | China |
| Research Site | Beijing | 100044 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Changsha | 410008 | China |
| Research Site | Changsha | 410013 | China |
| Research Site | Dalian | 116001 | China |
| Research Site | Foshan | 528000 | China |
| Research Site | Fuzhou | 350011 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Guangzhou | 510080 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hangzhou | 310020 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Harbin | 150081 | China |
| Research Site | Hefei | 230001 | China |
| Research Site | Jinan | 250001 | China |
| Research Site | Linyi | 276000 | China |
| Research Site | Nanchang | 330006 | China |
| Research Site | Nanchang | 330009 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Nanning | 530021 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shenyang | 110015 | China |
| Research Site | Tianjin | 300060 | China |
| Research Site | Ürümqi | 830000 | China |
| Research Site | Wuhan | 430079 | China |
| Research Site | Xi'an | 710004 | China |
| Research Site | Xi'an | 710061 | China |
| Research Site | Zhengzhou | 450008 | China |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Copenhagen Ø | 2100 | Denmark |
| Research Site | Odense | 5000 | Denmark |
| Research Site | Vejle | 7100 | Denmark |
| Research Site | Avignon | 84918 | France |
| Research Site | Besançon | 25000 | France |
| Research Site | Bordeaux | 33000 | France |
| Research Site | Brest | 29609 | France |
| Research Site | Caen | 14076 | France |
| Research Site | Dijon | 21079 | France |
| Research Site | Le Mans | 72000 | France |
| Research Site | Marseille | 13273 | France |
| Research Site | Montpellier | 34298 | France |
| Research Site | Nice | 06100 | France |
| Research Site | Paris | 75005 | France |
| Research Site | Pierre-Bénite | 69495 | France |
| Research Site | Plerin SUR MER | 22190 | France |
| Research Site | Rennes | 35000 | France |
| Research Site | Saint-Cloud | 92210 | France |
| Research Site | Saint-Herblain | 44805 | France |
| Research Site | Tours | 37000 | France |
| Research Site | Villejuif | 94805 | France |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Dresden | 01307 | Germany |
| Research Site | Freiburg im Breisgau | 79110 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | München | D-80336 | Germany |
| Research Site | Münster | 48149 | Germany |
| Research Site | Velbert | 42551 | Germany |
| Research Site | Budapest | 1062 | Hungary |
| Research Site | Budapest | 1122 | Hungary |
| Research Site | Budapest | 1145 | Hungary |
| Research Site | Győr | 9024 | Hungary |
| Research Site | Kecskemét | 6000 | Hungary |
| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Szolnok | 5000 | Hungary |
| Research Site | Tatabánya | 2800 | Hungary |
| Research Site | Bengaluru | 560099 | India |
| Research Site | Calicut | 673601 | India |
| Research Site | Kolkata | 700160 | India |
| Research Site | Marg Jaipur | 302004 | India |
| Research Site | New Delhi | 110 085 | India |
| Research Site | New Delhi | 110005 | India |
| Research Site | New Delhi | 110017 | India |
| Research Site | New Delhi | 110075 | India |
| Research Site | Surat | 395002 | India |
| Research Site | Thiruvananthapuram | 695011 | India |
| Research Site | Haifa | 3109601 | Israel |
| Research Site | Jerusalem | 9103102 | Israel |
| Research Site | Jerusalem | 91120 | Israel |
| Research Site | Kfar Saba | 44281 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Ramat Gan | 52621 | Israel |
| Research Site | Tel Aviv | 64239 | Israel |
| Research Site | Aviano | 33081 | Italy |
| Research Site | Bergamo | 24127 | Italy |
| Research Site | Candiolo | 10060 | Italy |
| Research Site | Cona | 44124 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Livorno | 57124 | Italy |
| Research Site | Messina | 98158 | Italy |
| Research Site | Milan | 20141 | Italy |
| Research Site | Milan | 20132 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Padova | 35128 | Italy |
| Research Site | Parma | Italy |
| Research Site | Prato | 59100 | Italy |
| Research Site | Tricase, Lecce | 73039 | Italy |
| Research Site | Udine | 33100 | Italy |
| Research Site | Akashi-shi | 673-8558 | Japan |
| Research Site | Bunkyō City | 113-8431 | Japan |
| Research Site | Chiba | 260-8717 | Japan |
| Research Site | Chūōku | 104-0045 | Japan |
| Research Site | Fukuoka | 811-1395 | Japan |
| Research Site | Gifu | 501-1194 | Japan |
| Research Site | Hidaka-shi | 350-1298 | Japan |
| Research Site | Hiroshima | 730-8518 | Japan |
| Research Site | Isehara | 259-1193 | Japan |
| Research Site | Kagoshima | 892-0833 | Japan |
| Research Site | Kashiwa | 277-8577 | Japan |
| Research Site | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Kitaadachi-gun | 362-0806 | Japan |
| Research Site | Kōtoku | 135-8550 | Japan |
| Research Site | Matsuyama | 791-0280 | Japan |
| Research Site | Nagoya | 460-0001 | Japan |
| Research Site | Naha | 901-0154 | Japan |
| Research Site | Niigata | 951-8566 | Japan |
| Research Site | Nishinomiya-shi | 663-8501 | Japan |
| Research Site | Okayama | 700-8558 | Japan |
| Research Site | Osaka | 541-8567 | Japan |
| Research Site | Osakasayama-shi | 589-8511 | Japan |
| Research Site | Sagamihara-shi | 252-0375 | Japan |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Shinagawa-ku | 142-8666 | Japan |
| Research Site | Shinjuku-ku | 160-0023 | Japan |
| Research Site | Shizuoka | 420-8527 | Japan |
| Research Site | Tsu | 514-8507 | Japan |
| Research Site | Yokohama | 241-8515 | Japan |
| Research Site | Alc. Cuauhtémoc | 06700 | Mexico |
| Research Site | Guadalajara Jalisco | 44280 | Mexico |
| Research Site | Guadalajra | 44260 | Mexico |
| Research Site | Mexico City | '14080 | Mexico |
| Research Site | Mexico City | 0 3100 | Mexico |
| Research Site | Mexico City | 6760 | Mexico |
| Research Site | México | 04700 | Mexico |
| Research Site | Monterrey | 64460 | Mexico |
| Research Site | Nuevo León | 66278 | Mexico |
| Research Site | Amsterdam | 1066 CX | Netherlands |
| Research Site | Breda | 4818 CK | Netherlands |
| Research Site | Hengelo | 7555 DL | Netherlands |
| Research Site | Leeuwarden | 8934 AD | Netherlands |
| Research Site | Rotterdam | 3015 GD | Netherlands |
| Research Site | Sittard-Geleen | 6162 BG | Netherlands |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Koszalin | 75-581 | Poland |
| Research Site | Krakow | 31-501 | Poland |
| Research Site | Lodz | 90-302 | Poland |
| Research Site | Rzeszów | 35-021 | Poland |
| Research Site | Warsaw | 02-781 | Poland |
| Research Site | Wroclaw | 53-413 | Poland |
| Research Site | Lisbon | 1500-650 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Lisbon | 1998-018 | Portugal |
| Research Site | Krasnodar | 350040 | Russia |
| Research Site | Moscow | 111123 | Russia |
| Research Site | Moscow | 115478 | Russia |
| Research Site | Moscow | 117997 | Russia |
| Research Site | Moscow | 121205 | Russia |
| Research Site | Saint Petersburg | 190103 | Russia |
| Research Site | Saint Petersburg | 195271 | Russia |
| Research Site | Saint Petersburg | 197758 | Russia |
| Research Site | Yaroslavl | 150054 | Russia |
| Research Site | Dammam | 31444 | Saudi Arabia |
| Research Site | Jeddah | 21423 | Saudi Arabia |
| Research Site | Jeddah | 23214 | Saudi Arabia |
| Research Site | Riyadh | 11426 | Saudi Arabia |
| Research Site | Riyadh | 11525 | Saudi Arabia |
| Research Site | Riyadh | 12713 | Saudi Arabia |
| Research Site | Bukit Merah | 169610 | Singapore |
| Research Site | Singapore | 119074 | Singapore |
| Research Site | Singapore | 258499 | Singapore |
| Research Site | Singapore | 308433 | Singapore |
| Research Site | Singapore | 329563 | Singapore |
| Research Site | Daegu | 41404 | South Korea |
| Research Site | Goyang-si | 10408 | South Korea |
| Research Site | Incheon | 22332 | South Korea |
| Research Site | Seongnam-si | 13620 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Barcelona | 08035 | Spain |
| Research Site | Barcelona | 08036 | Spain |
| Research Site | Barcelona | 08907 | Spain |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | El Palmar | 30120 | Spain |
| Research Site | Madrid | 28005 | Spain |
| Research Site | Madrid | 28007 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | San Sebastián | 20014 | Spain |
| Research Site | Seville | 41013 | Spain |
| Research Site | Valencia | 46026 | Spain |
| Research Site | Gothenburg | 413 45 | Sweden |
| Research Site | Örebro | 701 85 | Sweden |
| Research Site | Stockholm | 118 83 | Sweden |
| Research Site | Uppsala | 751 85 | Sweden |
| Research Site | Vaxjo | 35185 | Sweden |
| Research Site | Taichung | 40447 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Tainan | 710 | Taiwan |
| Research Site | Taipei | 10048 | Taiwan |
| Research Site | Taipei | 10449 | Taiwan |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Taipei | 235 | Taiwan |
| Research Site | Taoyuan | 333 | Taiwan |
| Research Site | Cambridge | CB2 0QQ | United Kingdom |
| Research Site | Cardiff | CF14 2TL | United Kingdom |
| Research Site | Edinburgh | EH4 2XR | United Kingdom |
| Research Site | Guildford | United Kingdom |
| Research Site | Leeds | LS9 7TF | United Kingdom |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | Manchester | M20 4BX | United Kingdom |
| Research Site | Northwood | HA6 2RN | United Kingdom |
| Derived |
| Tarantino P, Tolaney SM, Curigliano G. Trastuzumab deruxtecan (T-DXd) in HER2-low metastatic breast cancer treatment. Ann Oncol. 2023 Oct;34(10):949-950. doi: 10.1016/j.annonc.2023.07.003. Epub 2023 Jul 26. No abstract available. |
| Daiichi Sankyo Contact for Clinical Trial Information Phone: 908-992-6400 | View source |
| D9670C00001\_CSP\_Redacted | View source |
| D9670C00001\_CSR Synopsis\_Redacted | View source |
| D9670C00001\_Statistical Analysis Plan (SAP) | View source |
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg per meter square [m^2] orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion every week [qw] in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
| Randomized and Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent-to-treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T-DXd | Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
| BG001 | Chemotherapy | Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population | PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method. | The HER2-low population included the subset of participants in the ITT population with HER2 immunohistochemistry (IHC) 2+/ in situ hybridization (ISH)- and IHC 1+ as determined per the interactive response technology (IRT) data for HER2 IHC expression. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. | Posted | Median | 95% Confidence Interval | months | From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population | PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | ITT population: all randomized participants. HER2 IHC >0 <1+ population: subset of participants included in ITT population with HER2 IHC >0 <1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. HER2-low population: subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. Only participants with data collected in specified categories are reported. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Overall Survival (OS) in the Intent-to-Treat Population | OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | PFS per RECIST 1.1 assessed by Investigator was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. | Posted | Number | percentage of participants | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population | DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method. | The HER2-low population included the subset of participants in the ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per the IRT data for HER2 IHC expression. Only participants with response in each specified category are reported. | Posted | Median | Inter-Quartile Range | months | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population | ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to <10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters. | The ITT population included all randomized participants. The HER2 IHC >0 <1+ population included subset of participants included in ITT population with HER2 IHC >0 <1+ as determined by central laboratory testing and who have had at least 24 weeks of follow-up at time of interim futility PCD. Only participants with data collected in specified categories are reported. | Posted | Number | percentage of participants | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population | DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method. | The ITT population included all randomized participants. Only participants with response in each specified category are reported. | Posted | Median | Inter-Quartile Range | months | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method. | The HER2-low population included subset of participants in ITT population with HER2 IHC 2+/ISH- and IHC 1+ as determined per IRT data for HER2 IHC expression. The ITT population included all randomized participants. Only participants with data collected in specified categories are reported. | Posted | Median | 95% Confidence Interval | months | Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiation of the study drug until the 40-day (+7 days) safety follow-up visit. | The Safety population included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a | Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum. | The Pharmacokinetic population included all participants who received at least 1 dose of T-DXd per the protocol for whom any post-dose data were available. Only participants with data collected in specified timepoints are reported. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91 | EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization. | The ITT population included all randomized participants. Only participants with data collected in specified categories are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 91 |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58 | EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization. | The ITT population included all randomized participants. Only participants with data collected in specified categories are reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) and Week 58 |
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| Secondary | Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score | Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration. | The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan | Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration. | The ADA population included all participants who received at least 1 dose of T-DXd and who had a non-missing ADA result at any time. | Posted | Count of Participants | Participants | From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months) |
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| Secondary | Time to First Subsequent Treatment or Death (TFST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | TFST was defined as time from randomization to the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause. | Not Posted | Dec 2025 | From Day 1 up to 64 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Second Subsequent Treatment or Death (TSST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population | TSST was defined as time from randomization to the start date of the second subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause. | Not Posted | Dec 2025 | From Day 1 up to 64 months | Participants |
From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months).
The Safety population included all participants who received at least 1 dose of study drug. All-cause mortality was reported in ITT population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T-DXd | Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. | 161 | 436 | 88 | 434 | 427 | 434 |
| EG001 | Chemotherapy | Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. | 174 | 430 | 67 | 417 | 383 | 417 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Femoral hernia strangulated | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Tooth disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Human ehrlichiosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Meningoencephalitis bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Proteus infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Toxic cardiomyopathy | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Uterine perforation | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraneoplastic dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2024 | Jun 9, 2025 | SAP_003.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
| D000069287 | Capecitabine |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| White |
|
| Other |
|
| Not reported |
|
| Not Hispanic or Latino |
|
| Missing |
|
|
|
Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
| OG001 | Chemotherapy | Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
|
|
|
|
|
|
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.
|
|
|
|
|
|
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
|
|
|
| Chemotherapy |
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
|
|
| Chemotherapy |
Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met. |
|
|
|
|
|