Oncology Clinical Trial Finder
Breast Cancer

Terminated • Phase III • Stage III, IV • ER positive • PR positive • HER2 negative • CDK4/6 inhibitor absent • Medical Oncology • Post-Menopausal • Interventional

The following is imported from ClinicalTrials.gov:

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

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (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.

Study duration per participant was approximately 59 months, which includes a 33- month treatment period.

Breast Cancer

Study Design
Study type:


Estimated enrollment:

1068 participant

Actual study start date:

October 14, 2020

Eligibility Criteria
Ages eligible for study:

18 - 999

Sexes eligible for study:


Arms and Intervention
  • Amcenestrant-matching placebo

  • SAR439859

  • Palbociclib

  • Letrozole

  • Goserelin

  • Letrozole-matching placebo

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 childbearing 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial Information at Site
Last Updated:
Trial Information
ClinicalTrial.gov ID:


Estimated Enrollment:


Last Updated:


Principal Investigator

Clinical Sciences & Operations

Trial Sponsor


Study Location (589)

Investigational Site Number 8400002

Boston, Massachusetts, United States

Investigational Site Number 8400003

New York, New York, United States

Investigational Site Number 8400001

Seattle, Washington, United States

Investigational Site Number 8400009

Charleston, South Carolina, United States

Investigational Site Number 8400004

Dallas, Texas, United States

Investigational Site Number 8400015

Boston, Massachusetts, United States


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