NL-OMON55315
Completed
Phase 3
A randomized, multicenter, double-blind phase 3 study of amcenestrant (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 - EFC15935/AMEERA-5
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Advanced Breast cancer. Metastatic Breastcancer
- Sponsor
- Genzyme Europe BV
- Enrollment
- 17
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
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 disease ie, at least one measurable lesion evaluable per 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 Criteria
- •\-Known active brain metastases
- •\-Prior neo (adjuvant) treatment with any selective estrogen receptor degrader
- •\-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
Outcomes
Primary Outcomes
Not specified
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