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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1244-1767 | Registry Identifier | ICTRP | |
| BIG 20-01 | Other Identifier | BIG | |
| AFT-55 | Other Identifier | AFT | |
| EORTC-2033 | Other Identifier | EORTC | |
| 2021-000398-10 | EudraCT Number |
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Sponsor decision to prematurely stop the study, not linked to any safety concern
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| Name | Class |
|---|---|
| Breast International Group | OTHER |
| Alliance Foundation Trials, LLC. | OTHER |
| European Organisation for Research and Treatment of Cancer - EORTC | NETWORK |
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This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective was to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival.
The treatment duration per participant was to be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits were scheduled at the start of treatment, then at 4 weeks and 12 weeks after treatment start, and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5. For the follow-up period, visits were scheduled 30 days after last treatment and then every 12 months. Three periods were planned:
Study duration per participant was to be approximately 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amcenestrant with tamoxifen-matching placebo arm | Experimental | Amcenestrant dose, once daily, continuously. Tamoxifen-matching placebo, once daily, continuously. |
|
| Tamoxifen with amcenestrant-matching placebo | Active Comparator | Tamoxifen dose, once daily, continuously. Amcenestrant-matching placebo, once daily, continuously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amcenestrant | Drug | tablet, oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Breast Cancer-free Survival (IBCFS) | IBCFS was defined according to standardized definitions for efficacy outcome measure in adjuvant breast cancer trials (STEEP) criteria version 2.0 as the time interval from the date of randomization to the date of the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence (IIBTR): invasive breast cancer involving the same breast parenchyma as the original primary; local-regional invasive breast cancer recurrence: invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast; distant recurrence: metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer, invasive contralateral breast cancer; death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. | From randomization to the date of first occurrence of IBCFS event (maximum exposure duration: 155 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) | IDFS according to STEEP criteria version 2.0 was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: IIBTR: invasive breast cancer involving the same breast parenchyma as the original primary; local-regional invasive breast cancer recurrence: invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast; distant recurrence: metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; invasive contralateral breast cancer; second non-breast primary invasive cancer; death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. |
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Inclusion Criteria:
Adjuvant AI therapy was discontinued due to AI treatment-related toxicity; Minimum of 6 months duration and maximum of 30 months duration (from initiation of first AI if there was a switch between AIs) of AI therapy was required.
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Etienne Brain, MD PhD | Institut Curie (Saint-Cloud and Paris), 35 rue Dailly, 92210 Saint-Cloud | Study Chair |
| David Cameron, Professor of Oncology | University of Edinburgh Cancer Centre, institute of Genetics and Cancer, Western General Hospital, Crewe Road South, EDINBURGH EH4 2XU Scotland | Study Chair |
| Otto Metzger, MD | Dana-Farber Cancer Institute, 450 Brookline Avenue Yawkey 1250 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :1521622 | Santiago | Reg Metropolitana de Santiago | Chile | |||
| Investigational Site Number :1561599 |
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| Label | URL |
|---|---|
| EFC16133 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Randomization stratified by prior exposure to (neo)adjuvant aromatase inhibitor therapy, (neo)adjuvant chemotherapy & HER2 status, CDK4/6 inhibitor (Yes/No), geographic regions, men' or peri-/pre-menopausal women vs. post-menopausal women. Study was initially planned with two treatment arms (i.e. amcenestrant & tamoxifen), however no participants were exposed to tamoxifen arm due to premature discontinuation & study closure by sponsor thus none of the participants were enrolled in tamoxifen arm.
The study was conducted at 2 active centers in Chile and China. A total of 6 participants were screened between 17 February 2022 and 11 August 2022, of which 3 participants were randomized and exposed to study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amcenestrant 200 mg + Tamoxifen-Matching Placebo | Participants received amcenestrant 200 mg along with tamoxifen-matching placebo orally (PO), once a day (QD) from Day 1 to Day 28 of each 28-day treatment cycle and were followed-up until diagnosis of disease recurrence per invasive breast cancer-free survival (IBCFS) definition (recurrence of one of following: Ipsilateral invasive breast tumor recurrence (IIBTR); local-regional invasive breast cancer recurrence; distant recurrence, invasive contralateral breast cancer, death) or any other withdrawal criterion whichever occurs first (maximum exposure duration: 155 days). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2022 |
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Double-dummy
| Tamoxifen |
| Drug |
tablet, oral |
|
| Amcenestrant-matching placebo | Drug | tablet, oral |
|
| Tamoxifen-matching placebo | Drug | tablet, oral |
|
| From randomization to the date of first occurrence of IDFS event (maximum exposure duration: 155 days) |
| Distant Recurrence-free Survival (DRFS) | DRFS according to STEEP criteria version 2.0 was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: distant recurrence or death attributable to any cause (including breast cancer, non-breast cancer, or unknown cause). | From randomization to the date of the first occurrence of distant recurrence or death due to any cause, whichever occurs first (maximum exposure duration: 155 days) |
| Locoregional Recurrences-free Survival (LRRFS) | LRRFS was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: local/regional ipsilateral recurrence, invasive contralateral breast cancer or death attributable to any cause (including breast cancer, non-breast cancer, or unknown cause). | From randomization to the date of the first occurrence of local/regional ipsilateral recurrence or breast cancer or death due to any cause, whichever occurs first (maximum exposure duration: 155 days) |
| Overall Survival (OS) | Overall survival was defined as the time interval from the date of randomization to the date of documented death (due to any cause). | From randomization to the date of death due to any cause (maximum exposure duration: 155 days) |
| Breast Cancer-specific Survival (BCSS) | BCSS was defined as the time interval from the date of randomization to the date of documented death attributable to breast cancer cause. | From randomization to the date of death due to breast cancer (maximum exposure duration: 155 days) |
| Change From Baseline in Overall Side Effect Bother As Measured By Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5) Scale Scores | FACT-GP5 is a single-item from the Functional Assessment of Cancer Therapy-General (FACT-G) scale in which participants report their bother by side effects of treatment response. Responses were given on a 5- point Likert-type scale with score range from 0 (not at all bothered by side effect) to 4 (very much bothered by side effects). Higher scores indicate a higher degree of side effect bother. End of treatment (EOT) visit was 30 days after the last IMP administration. | Baseline, Cycle 3, 4, 5, 6, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23): Systemic Therapy Side Effects Scale Score | QLQ-BR23: 23-item disease-specific participant reported outcome measure of disease-related symptoms, treatment-related symptoms, and functioning relevant to participants with breast cancer. It consisted of 4 functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and 4 symptoms scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptom). Systemic therapy side effects scale consisted of 7 items & each item was rated on a 4-point scale with responses as: 1= not at all, 2= a little, 3= quite a bit, 4= very much. A linear transformation was applied to raw scores so that all transformed scores are within 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. Negative change from baseline= improvement of side effects, positive change = deterioration. EOT visit was 30 days after last IMP administration. | Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
| Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30): Global Health Status/Quality of Life (GHQ) Scale Score | EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant. EOT visit was 30 days after last IMP administration. | Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
| Plasma Concentration of Amcenestrant | Pre-dose on Cycle 2 Day 1, Cycle 7 Day 1, Cycle 13 Day 1 and Cycle 25 Day 1 |
| Haikou |
| 570311 |
| China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on the randomized population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Amcenestrant 200 mg + Tamoxifen-Matching Placebo | Participants received amcenestrant 200 mg along with tamoxifen-matching placebo orally PO, QD from Day 1 to Day 28 of each 28-day treatment cycle and were followed-up until diagnosis of disease recurrence per IBCFS definition (recurrence of one of following: IIBTR; local-regional invasive breast cancer recurrence; distant recurrence, invasive contralateral breast cancer, death) or any other withdrawal criterion whichever occurs first (maximum exposure duration: 155 days). |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Race data was collected for 1 participant only; and was not presented in order to protect participant confidentiality. | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Invasive Breast Cancer-free Survival (IBCFS) | IBCFS was defined according to standardized definitions for efficacy outcome measure in adjuvant breast cancer trials (STEEP) criteria version 2.0 as the time interval from the date of randomization to the date of the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence (IIBTR): invasive breast cancer involving the same breast parenchyma as the original primary; local-regional invasive breast cancer recurrence: invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast; distant recurrence: metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer, invasive contralateral breast cancer; death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. | No invasive breast cancer event data was collected because of the early termination of the study by the Sponsor and thus IBCFS was not analyzed. Therefore, no data is reported for this outcome measure. | Posted | From randomization to the date of first occurrence of IBCFS event (maximum exposure duration: 155 days) |
|
| |||||||||||||||||||
| Secondary | Invasive Disease-Free Survival (IDFS) | IDFS according to STEEP criteria version 2.0 was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: IIBTR: invasive breast cancer involving the same breast parenchyma as the original primary; local-regional invasive breast cancer recurrence: invasive breast cancer in the axilla, regional lymph nodes, chest wall, and skin of the ipsilateral breast; distant recurrence: metastatic disease-breast cancer that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer; invasive contralateral breast cancer; second non-breast primary invasive cancer; death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. | No Invasive disease event data was collected because of the early termination of the study by the Sponsor and thus IDFS was not analyzed. Therefore, no data is reported for this outcome measure. | Posted | From randomization to the date of first occurrence of IDFS event (maximum exposure duration: 155 days) |
| ||||||||||||||||||||
| Secondary | Distant Recurrence-free Survival (DRFS) | DRFS according to STEEP criteria version 2.0 was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: distant recurrence or death attributable to any cause (including breast cancer, non-breast cancer, or unknown cause). | No distant recurrence event data was collected because of the early termination of the study by the Sponsor and thus DRFS was not analyzed. Therefore, no data is reported for this outcome measure. | Posted | From randomization to the date of the first occurrence of distant recurrence or death due to any cause, whichever occurs first (maximum exposure duration: 155 days) |
|
| |||||||||||||||||||
| Secondary | Locoregional Recurrences-free Survival (LRRFS) | LRRFS was defined as the time interval from the date of randomization to the date of the first occurrence of one of the following events: local/regional ipsilateral recurrence, invasive contralateral breast cancer or death attributable to any cause (including breast cancer, non-breast cancer, or unknown cause). | No locoregional recurrences event data was collected because of the early termination of the study by the Sponsor and thus LRRFS was not analyzed. Therefore, no data is reported for this outcome measure. | Posted | From randomization to the date of the first occurrence of local/regional ipsilateral recurrence or breast cancer or death due to any cause, whichever occurs first (maximum exposure duration: 155 days) |
|
| |||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was defined as the time interval from the date of randomization to the date of documented death (due to any cause). | Analysis was performed on randomized population. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of death due to any cause (maximum exposure duration: 155 days) |
|
| ||||||||||||||||
| Secondary | Breast Cancer-specific Survival (BCSS) | BCSS was defined as the time interval from the date of randomization to the date of documented death attributable to breast cancer cause. | Analysis was performed on randomized population. | Posted | Median | 95% Confidence Interval | months | From randomization to the date of death due to breast cancer (maximum exposure duration: 155 days) |
|
| ||||||||||||||||
| Secondary | Change From Baseline in Overall Side Effect Bother As Measured By Functional Assessment of Cancer Therapy Item GP-5 (FACT-GP5) Scale Scores | FACT-GP5 is a single-item from the Functional Assessment of Cancer Therapy-General (FACT-G) scale in which participants report their bother by side effects of treatment response. Responses were given on a 5- point Likert-type scale with score range from 0 (not at all bothered by side effect) to 4 (very much bothered by side effects). Higher scores indicate a higher degree of side effect bother. End of treatment (EOT) visit was 30 days after the last IMP administration. | Evaluable data was collected for 2 participants only; and thus, was not presented to protect participant confidentiality. | Posted | Baseline, Cycle 3, 4, 5, 6, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC-QLQ-BR23): Systemic Therapy Side Effects Scale Score | QLQ-BR23: 23-item disease-specific participant reported outcome measure of disease-related symptoms, treatment-related symptoms, and functioning relevant to participants with breast cancer. It consisted of 4 functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and 4 symptoms scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptom). Systemic therapy side effects scale consisted of 7 items & each item was rated on a 4-point scale with responses as: 1= not at all, 2= a little, 3= quite a bit, 4= very much. A linear transformation was applied to raw scores so that all transformed scores are within 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. Negative change from baseline= improvement of side effects, positive change = deterioration. EOT visit was 30 days after last IMP administration. | Evaluable data was collected for 1 participant only; and was not presented to protect participant confidentiality. | Posted | Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
| ||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30): Global Health Status/Quality of Life (GHQ) Scale Score | EORTC-QLQ-C30: cancer-specific instrument with 30 questions for evaluation of new chemotherapy & assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were rated on a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were rated on a 7-point scale (1/Very Poor to 7/Excellent). All scales were transformed from raw scores to linear scales ranging 0 to 100. A high score represented a favorable outcome with a best quality of life for participant. EOT visit was 30 days after last IMP administration. | Evaluable data was collected for 1 participant only; and was not presented to protect participant confidentiality. | Posted | Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 34, 40, 46, 52, & 58 and at end of treatment (maximum exposure: any day up to 155 days) |
| ||||||||||||||||||||
| Secondary | Plasma Concentration of Amcenestrant | Data was not collected and analyzed for this outcome measure due to the early termination of the study by the Sponsor. | Posted | Pre-dose on Cycle 2 Day 1, Cycle 7 Day 1, Cycle 13 Day 1 and Cycle 25 Day 1 |
|
|
Adverse Events (AE) data was collected from first dose of study drug administration up to 30 days after the last treatment administration (maximum exposure duration:155 days)
Analysis was performed on all randomized 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 | Amcenestrant 200 mg + Tamoxifen-Matching Placebo | Participants received amcenestrant 200 mg along with tamoxifen-matching placebo orally PO, QD from Day 1 to Day 28 of each 28-day treatment cycle and were followed-up until diagnosis of disease recurrence per IBCFS definition (recurrence of one of following: IIBTR; local-regional invasive breast cancer recurrence; distant recurrence, invasive contralateral breast cancer, death) or any other withdrawal criterion whichever occurs first (maximum exposure duration: 155 days). | 0 | 3 | 0 | 3 | 2 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nail Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Glucose Intolerance | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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Due to premature discontinuation and closure of study decided by the Sponsor, only safety data were summarized and reported, and no efficacy data was collected.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Mar 31, 2023 |
| Prot_SAP_000.pdf |
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| 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 |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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