Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 17, 2025
  • participants needed
    372
  • sponsor
    Sanofi
Updated on 17 April 2021
estrogen
breast cancer
endocrine therapy
metastasis
hormone therapy
advanced breast cancer
tamoxifen
adenocarcinoma
fulvestrant
estrogen receptor
anastrozole
breast adenocarcinoma
exemestane
locally advanced breast cancer
letrozole
ESR1
immunological adjuvant

Summary

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

Secondary Objectives:

  • To compare the overall survival in the 2 treatment arms
  • To assess the objective response rate in the 2 treatment arms
  • To evaluate the disease control rate in the 2 treatment arms
  • To evaluate the clinical benefit rate in the 2 treatment arms
  • To evaluate the duration of response in the 2 treatment arms
  • To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
  • To evaluate the pharmacokinetics of amcenestrant as single agent
  • To evaluate health related quality of life in the 2 treatment arms
  • To compare the overall safety profile in the 2 treatment arms

Description

The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days of study treatment), and an end of treatment (EOT) visit at least 30 days (or until the participant receive another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, death or upon participant's request.

An extension of recruitment for Chinese participants is planned in this study: After completion of randomization in the global part of the study, randomization will continue in China until approximately 90 Chinese participants are randomized.

Details
Condition Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer Metastatic
Treatment Letrozole, tamoxifen, anastrozole, exemestane, fulvestrant, SAR439859, Endocrine monotherapy as per physician choice, Amcenestrant
Clinical Study IdentifierNCT04059484
SponsorSanofi
Last Modified on17 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer Metastatic or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer Metastatic or Metastatic Breast Cancer?
Do you have any of these conditions: Breast Cancer Metastatic or Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Metastatic Breast Cancer or Breast Cancer Metastatic or Stage IV Breast Cancer?
Do you have any of these conditions: Breast Cancer Metastatic or Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Breast Cancer Metastatic or Metastatic Breast Cancer or Stage IV Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Breast Cancer Metastatic or Metastatic Breast Cancer or Stage IV Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer Metastatic or Metastatic Breast Cancer?
Is your age greater than or equal to 18 yrs?
Do you have any of these conditions: Stage IV Breast Cancer or Breast Cancer Metastatic or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Metastatic Breast Cancer or Breast Cancer Metastatic or Stage IV Breast Cancer?
Do you have any of these conditions: Breast Cancer Metastatic or Stage IV Breast Cancer or Metastatic Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Stage IV Breast Cancer or Breast Cancer Metastatic?
Do you have any of these conditions: Metastatic Breast Cancer or Breast Cancer Metastatic or Stage IV Breast Cancer?
Do you have any of these conditions: Metastatic Breast Cancer or Breast Cancer Metastatic or Stage IV Breast Cancer?
Do you have any of these conditions: Stage IV Breast Cancer or Metastatic Breast Cancer or Breast Cancer Metastatic?
Do you have Breast Cancer Metastatic?
Gender: Male or Female
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 nave 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

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 above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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