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

STATUS

Recruiting
End date

Sep 12, 2026
participants needed

810
sponsor

Sanofi

Send

Updated on 19 February 2024

See if I qualify

cancer

breast cancer

measurable disease

metastasis

solid tumour

palbociclib

solid tumors

letrozole

advanced breast cancer

goserelin

her2-negative breast cancer

her2/neu-negative breast cancer

HER2

Summary

Show definitions

Primary Objective:

To determine whether SAR439859 in combination with palbociclib improves progression 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 the pharmacokinetics of SAR439859, goserelin, 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

Description

Study duration per participant is approximately 57 months, which includes a 24-month treatment period

Details

Condition	Breast Cancer, Breast Cancer
Age	18years - 100years
Treatment	Goserelin, Letrozole, SAR439859, Letrozole-matching placebo, SAR439859-matching placebo, Ibrance
Clinical Study Identifier	NCT04478266
Sponsor	Sanofi
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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 or non-measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1
	Eastern Cooperative Oncology Group (ECOG) performance status 0-1
	Participants should be willing to provide tumor tissue
	Capable of giving informed consent
Exclusion Criteria
	Known brain metastases that are untreated, symptomatic or require treatment to control symptoms
	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
	The above information is not intended to contain all considerations relevant
	to a patient's potential participation in a clinical trial

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