National Cancer Centre Singapore
Recruiting
Singapore 169610
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
- Trial number:
-
NCT04478266
- Trial phase:
- 3
- Study type:
- targeted, hormonal
- Overall status:
- Recruiting
Study start date
October, 2020
Scientific title
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
Summary
Primary Objective:
To determine whether Amcenestrant (SAR439859) in combination with palbociclib
improvesprogression 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 progression-free survival on next line of therapy
- To evaluate the pharmacokinetics of amcenestrant, 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
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 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 criteria: - 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 - 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.
Study design
Primary purpose:
Treatment,
Allocation:
Randomized,
Intervention model:
Parallel Assignment,
Masking:
Quadruple,
Subject masked:
Yes,
Caregiver masked:
Yes,
Investigator masked:
Yes,
Outcomes assessor masked:
Yes,
Conditions
Breast Cancer
Other study ID numbers
EFC15935; 2020-001824-33; U1111-1233-0486
Choose trial site (199)
Curie Oncology (Novena)
Recruiting
Singapore 329563