Amcenestrant SAR439859 plus palbociclib as first line therapy for patients with ER(+) HER2(-) advanced breast cancer

Phase 1

• Conditions: ER (+), HER2 (-) breast cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10028997Term: Neoplasm malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001824-33-PL
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1333

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 533

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified