Phase 2 Study of SAR439859 versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3)

Phase 1

• Conditions: Cancer.; MedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004593-98-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 489

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 269

Exclusion Criteria

- Eastern Cooperative Oncology Group performance status >/= 2
- Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859. 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 screeening.
- 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 least3 months before randomization.
- Treatment with drugs that have the potential to inhibit UGT less than 2 weeks before randomization .
- Treatment with strong or moderate CYP3A/CYP2C8 inducers within 2 weeks before randomization.
- Ongoing treatment with drugs that are substrate of P-glycoprotein (P gp) (dabigatran, digoxin, fexofenadine).
- Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
- Inadequate hematological, coagulation, renal and liver functions.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified