Overview

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Goserelin
Letrozole
Palbociclib
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 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.