Amcenestrant (SAR439859) plus palbociclib as first line therapy for patients with ER(+) HER2(-) advanced breast cancer
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2031200210
- Lead Sponsor
- Tanaka Tomoyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1066
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 nonmeasurable 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 endocrine therapy
- Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
- 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
- Secondary Outcome Measures
Name Time Method