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Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

NCT03284957 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-11-24

Study results available
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Summary

Primary Objectives:

Dose Escalation:

* To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy and in combination with palbociclib
* To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in combination with the selected amcenestrant dose for the combination therapy

Safety Run-In:

\- To confirm the RD of amcenestrant in combination with alpelisib

Dose Expansion:

* Antitumor activity using objective response rate (ORR)
* Overall safety profile of amcenestrant administered in combination with palbociclib, alpelisib, everolimus, and abemaciclib

Secondary Objectives:

* Overall safety profile of amcenestrant monotherapy and in combination
* Pharmacokinetic (PK) profile of amcenestrant administered as monotherapy or in combination and PK profile of palbociclib, alpelisib, everolimus and abemaciclib
* Antitumor activity using ORR, the clinical benefit rate (CBR) and progression free survival (PFS)
* Time to first tumor response
* Residual ER availability with positron emission tomography (PET) scan \[(18)F\] fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant
* Food effect on PK of amcenestrant
* Potential induction/inhibition effect of amcenestrant on cytochrome P450 (CYP) 3A using 4b-OH cholesterol

Conditions

Interventions

DRUG

Amcenestrant

Pharmaceutical form: capsule Route of administration: oral

DRUG

Palbociclib

Pharmaceutical form: capsule Route of administration: oral

DRUG

Alpelisib

Pharmaceutical form: tablet Route of administration: oral

DRUG

Everolimus

Pharmaceutical form: tablet

DRUG

Abemaciclib

Pharmaceutical form: tablet

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2024-11-08
Completion
2024-11-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Italy
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284957 on ClinicalTrials.gov