Overview
Primary Objective:
To determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease.
Secondary Objective:
- To compare the overall survival in both treatment arms
- To evaluate the objective response rate in both treatment arms
- To evaluate the duration of response in both treatment arms
- To evaluate the clinical benefit rate in both treatment arms
- To evaluate the pharmacokinetics of SAR439859, goserelin, and palbociclib
- To evaluate health-related quality of life in both treatment arms
- To evaluate the time to first chemotherapy in both treatment arms
- To evaluate safety in both treatment arms
Description
Study duration per participant is approximately 57 months, which includes a 24-month treatment period
Eligibility
Inclusion criteria :
- Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
- Confirmed diagnosis of ER+/HER2- breast cancer
- No prior systemic treatment for loco-regional recurrent or metastatic disease
- Measurable or non-measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Participants should be willing to provide tumor tissue
- Capable of giving informed consent
Exclusion criteria:
- Known brain metastases that are untreated, symptomatic or require treatment to control symptoms
- Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
- Inadequate organ and marrow function
- Disease recurrence while on, or within 12 months of completion of (neo)adjuvant aromatase inhibitor-containing therapy
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
- Male participants who disagree to follow contraception
- Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
- Participants with significant concomitant illness
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.