Phase 2 Study of SAR439859 versus Physician’s Choice in Premenopausal and Postmenopausal Locally Advanced or Metastatic ER-positive Breast Cancer

Phase 1

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

• Registration Number: EUCTR2018-004593-98-ES
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 282

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
-For patients with tumor accessible for paired biopsy at study entry: baseline samples, formalin fixed paraffin embedded (FFPE) archived biopsy samples (within 3 months prior initiation of study treatment) can be used, but preferably fresh biopsies from primary tumor or recurrence or metastasis, will be collected.
- Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
Participants must have progressed after at least 6 months of a continuous prior endocrine therapy for advanced breast cancer
- Participants must be postmenopausal women,
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 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 127

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 bone-only metastasis .
- 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 antiviral agents, antifungal, and antioxidant agents less than 2 weeks before randomization .
- Treatment with strong or moderate CYP3A 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, renall and liver functions.

Study & Design

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