Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
Eligible patients will be randomised to receive a continuous dose of either SAR439859 or Letrozole once-daily, in combination with a dose of Palbociclib once daily on days 1-21 of every 28-day cycle. Goserelin may also be administered once every 4 weeks in pre/peri menopausal women and men.
Conditions
This trial is treating people with ER+, HER2- breast cancer
Eligibility
Inclusion
- 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 disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Participants should be willing to provide tumor tissue.
- Capable of giving informed consent.
Exclusion
- Known active brain metastases.
- 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 endocrine therapy.
- Pregnant, breastfeeding, or woman of childbearing 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Sanofi Aventis
Scientific Title
A Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
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