Clinical Trials List
Protocol NumberACT16105
NCT Number(ClinicalTrials.gov Identfier)NCT04059484
2019-11-01 - 2022-12-31
Phase II
Recruiting5
ICD-10C50.919
Malignant neoplasm of unspecified site of unspecified female breast
An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies
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Trial Applicant
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Sponsor
Sanofi
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Ting Hsu Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- Kuo-Ting Lee Division of General Surgery
- Jui-Hung Tsai Division of Hematology & Oncology
- Yao-Lung Kuo Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Jung Chen Division of General Surgery
- Chen-Teng Wu Division of General Surgery
- Yao-Chung Wu Division of General Surgery
- HWEI-CHUNG WANG Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林季宏 Division of Hematology & Oncology
- 陳怡君 Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- MING-YANG WANG Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張平穎 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 廖國秀醫師 Division of Hematology & Oncology
- 何景良 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 賴學緯 Division of Others
- 吳宜穎 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 于承平醫師 Division of Hematology & Oncology
- 于承平 Division of Hematology & Oncology
- 陳宇欽 Division of Hematology & Oncology
- 廖國秀 Division of General Surgery
- 賴學緯醫師 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies
Objectives
Primary Objective:
To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer
Test Drug
SAR439859
SAR439859
SAR439859
Active Ingredient
SAR439859
SAR439859
SAR439859
Dosage Form
capsule
capsule
capsule
Dosage
100
100
100
Endpoints
Primary Outcome Measures :
Progression free survival (PFS) [ Time Frame: Up to 18 months after the first randomized participant ]
PFS is defined as the time interval from the date of randomization to the date of documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever comes first.
Progression free survival (PFS) [ Time Frame: Up to 18 months after the first randomized participant ]
PFS is defined as the time interval from the date of randomization to the date of documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever comes first.
Inclution Criteria
Inclusion criteria :
18 years or older.
Histological or cytological diagnosis of adenocarcinoma of the breast.
Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
ER positive status.
HER2 negative status.
Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
In the main study, a prior treatment with a CDK 4/6 inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
Male or Female.
18 years or older.
Histological or cytological diagnosis of adenocarcinoma of the breast.
Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
ER positive status.
HER2 negative status.
Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
In the main study, a prior treatment with a CDK 4/6 inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
Male or Female.
Exclusion Criteria
Exclusion criteria:
Eastern Cooperative Oncology Group performance status ≥2.
Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules.
Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed.
Severe uncontrolled systemic disease at screening .
Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader (SERD) compound, except fulvestrant if stopped for at least 3 months before randomization.
Treatment with drugs that have the potential to inhibit UGT less than 2 weeks before randomization.
Treatment with strong CYP3A inducers within 2 weeks before randomization.
Ongoing treatment with drugs that are substrate of P-glycoprotein (P gp) (dabigatran, digoxin, fexofenadine), or of Breast Cancer Resistance Protein (BCRP) (rosuvastatin, sulfasalazine).
Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
Inadequate hematological, coagulation, renal and liver functions.
Eastern Cooperative Oncology Group performance status ≥2.
Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules.
Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed.
Severe uncontrolled systemic disease at screening .
Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader (SERD) compound, except fulvestrant if stopped for at least 3 months before randomization.
Treatment with drugs that have the potential to inhibit UGT less than 2 weeks before randomization.
Treatment with strong CYP3A inducers within 2 weeks before randomization.
Ongoing treatment with drugs that are substrate of P-glycoprotein (P gp) (dabigatran, digoxin, fexofenadine), or of Breast Cancer Resistance Protein (BCRP) (rosuvastatin, sulfasalazine).
Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
Inadequate hematological, coagulation, renal and liver functions.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
282 participants
