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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012019-17 | EudraCT Number |
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This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m^2 iv, increased to 100 mg/m^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T+P Concomitant Anthracycline-based chemotherapy | Experimental | 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab (T) and pertuzumab (P) every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
| T+P Sequential Anthracycline-based chemotherapy | Experimental | FEC every three weeks for three cycles, followed by docetaxel, trastuzumab (T) and pertuzumab (P) every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. |
|
| T+P Concomitant Non-Anthracycline chemotherapy | Experimental | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab (P) every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | 840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events. | From baseline up to approximately 3.5 years |
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period. | From baseline up to approximately 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner. | At surgery, after 18 weeks (6 cycles) of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banja Luka | 78000 | Bosnia and Herzegovina | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29223479 | Derived | Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Waldron-Lynch M, Eng-Wong J, Kirk S, Cortes J. Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer. Eur J Cancer. 2018 Jan;89:27-35. doi: 10.1016/j.ejca.2017.10.021. Epub 2017 Dec 8. | |
| 28057664 |
Not provided
Not provided
Not provided
This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | T+P Concomitant Anthracycline-based Chemotherapy | 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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|
| Trastuzumab | Drug | 8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks. |
|
|
| FEC | Drug | 5-fluorouracil 500 mg/m^2, epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2. |
|
| Docetaxel | Drug | 75 mg/m^2 for the first dose; 100 mg/m^2 if no dose limiting toxicity occurs. |
|
| TCH | Drug | Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m^2. All treatments were given every three weeks by the IV route. |
|
| Efficacy: Clinical Response Rate | Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions. | During each 3-week cycle of 6 total cycles: up to 18 weeks |
| Efficacy: Time to Clinical Response | Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions. | Up to 18 weeks |
| Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment. | At approximately 18 weeks |
| Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day. | From baseline to end of study up to 5 years |
| Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free. | From baseline to end of study up to 5 years |
| Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day. | From baseline to end of study up to 5 years |
| Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Percentage of participants with signs or symptoms of cardiac events. | From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) |
| Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Percentage of participants with LVEF events without signs or symptoms of cardiac events. | From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) |
| Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage. | From baseline up to approximately 3.5 years |
| Sarajevo |
| 71000 |
| Bosnia and Herzegovina |
| Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| São Paulo | São Paulo | 01317-000 | Brazil |
| Vancouver | British Columbia | V5Z 4E6 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Pula | 52100 | Croatia |
| Heidelberg | 69120 | Germany |
| Kiel | 24105 | Germany |
| Regensburg | 93053 | Germany |
| Trier | 54290 | Germany |
| Troisdorf | 53840 | Germany |
| Ulm | 89075 | Germany |
| Heraklion | 71110 | Greece |
| Thessaloniki | 56429 | Greece |
| Rome | Lazio | 00168 | Italy |
| Monza | Lombardy | 20900 | Italy |
| S. Fermo Della Battaglia (CO) | Lombardy | 22020 | Italy |
| Mexico City | 06760 | Mexico |
| Xalapa | 91130 | Mexico |
| Auckland | 1023 | New Zealand |
| Aveiro | 3814-501 | Portugal |
| Lisbon | 1099-023 | Portugal |
| Bucharest | 050098 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Iași | 700106 | Romania |
| Belgrade | 11000 | Serbia |
| Belgrade | 11080 | Serbia |
| Durban | 4058 | South Africa |
| Durban | 4091 | South Africa |
| Pretoria | 0002 | South Africa |
| Daegu | 702-210 | South Korea |
| Seoul | 152-703 | South Korea |
| Barcelona | Barcelona | 08035 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Madrid | Madrid | 28222 | Spain |
| Eskilstuna | 63188 | Sweden |
| Stockholm | 17176 | Sweden |
| Sundsvall | 85186 | Sweden |
| Umeå | 90185 | Sweden |
| Baden | 5405 | Switzerland |
| Zurich | 8008 | Switzerland |
| Zurich | 8091 | Switzerland |
| Taichung | 404 | Taiwan |
| Taipei | 00112 | Taiwan |
| Nassau | N9311 | The Bahamas |
| Bournemouth | BH7 7DW | United Kingdom |
| Derby | DE1 2QY | United Kingdom |
| Guildford | GU2 5XX | United Kingdom |
| Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| Truro | TR1 3LJ | United Kingdom |
| Westcliffe-on-sea | SS0 0RY | United Kingdom |
| Derived |
| Swain SM, Schneeweiss A, Gianni L, Gao JJ, Stein A, Waldron-Lynch M, Heeson S, Beattie MS, Yoo B, Cortes J, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017 Apr 1;28(4):761-768. doi: 10.1093/annonc/mdw695. |
| 25005255 | Derived | Schneeweiss A, Chia S, Hegg R, Tausch C, Deb R, Ratnayake J, McNally V, Ross G, Kiermaier A, Cortes J. Evaluating the predictive value of biomarkers for efficacy outcomes in response to pertuzumab- and trastuzumab-based therapy: an exploratory analysis of the TRYPHAENA study. Breast Cancer Res. 2014 Jul 8;16(4):R73. doi: 10.1186/bcr3690. |
| 23704196 | Derived | Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22. |
| FG001 |
| T+P Sequential Anthracycline-based Chemotherapy |
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. |
| FG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who were randomized and received study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | T+P Concomitant Anthracycline-based Chemotherapy | 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
| BG001 | T+P Sequential Anthracycline-based Chemotherapy | FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. |
| BG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events. | Safety population included all participants who were randomized and received study drug. | Posted | Number | percentage of participants | From baseline up to approximately 3.5 years |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period. | Safety population included all participants who were randomized and received study drug. | Posted | Number | percentage of participants | From baseline up to approximately 18 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner. | Intent to treat (ITT) population included all participants who were randomized to treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At surgery, after 18 weeks (6 cycles) of treatment |
| |||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Clinical Response Rate | Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions. | ITT population included all participants who were randomized to treatment. | Posted | Number | percentage of participants | During each 3-week cycle of 6 total cycles: up to 18 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Time to Clinical Response | Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions. | ITT population included all participants who were randomized to treatment. | Posted | Median | 95% Confidence Interval | weeks | Up to 18 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment. | Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned. | Posted | Number | percentage of participants | At approximately 18 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day. | ITT population included all participants who were randomized to treatment. | Posted | Number | percentage of participants | From baseline to end of study up to 5 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free. | ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period. | Posted | Number | percentage of participants | From baseline to end of study up to 5 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day. | ITT population included all participants who were randomized to treatment. | Posted | Number | percentage of participants | From baseline to end of study up to 5 years |
| ||||||||||||||||||||||||||||||||||
| Secondary | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Percentage of participants with signs or symptoms of cardiac events. | Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period. | Posted | Number | percentage of participants | From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Percentage of participants with LVEF events without signs or symptoms of cardiac events. | Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period. | Posted | Number | percentage of participants | From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage. | Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable. | Posted | Mean | Standard Deviation | percentage (ejection fraction) | From baseline up to approximately 3.5 years |
|
Up to approximately 5 years
Safety population included all participants who were randomized and received study drug.
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+P Concomitant Anthracycline-based Chemotherapy | 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. | 23 | 72 | 72 | 72 | ||
| EG001 | T+P Sequential Anthracycline-based Chemotherapy | FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. | 18 | 75 | 73 | 75 | ||
| EG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. | 31 | 76 | 76 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Conduction disorder | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Breast necrosis | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Palmar -plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| 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 |
|---|---|
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
| OG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
| OG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
| OG002 | T+P Concomitant Non-Anthracycline Chemotherapy | Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. |
|
|
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
|
|