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
- Conditions
- Advanced Breast cancer. Metastatic Breastcancer10006291
- Registration Number
- NL-OMON55315
- Lead Sponsor
- Genzyme Europe BV
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
-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
-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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression Free survival<br /><br><br /><br>Progression-free survival is defined as the time interval from the date of<br /><br>randomization to the date<br /><br>of first documented tumor progression as per Response Evaluation Criteria in<br /><br>Solid Tumors<br /><br>(RECIST 1.1) or death (due to any cause), whichever come first.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondairy endpoints are the overall survival rate, objective response rate,<br /><br>duration of response,clinical benefit rate, progression-free survival on next<br /><br>line of therapy (PFS2), PK plasma concentrations, number of participants with<br /><br>treatment emergent adverse events and SAEs, time to first chemotherapy, and<br /><br>questionnaires EQ5D-5L, QlQ-C30,QlQ-BR45, QLQ-BR23</p><br>