Goserelin for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Breast Cancer+1 More
Goserelin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination of drugs to see if it can improve progression-free survival for people with ER+, HER2- advanced breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: From Baseline up to end of study (approximately 6.5 years)

Year 4
Disease- and treatment-related quality of life will be assessed using the EORTC breast cancer module (QLQ-BR23) questionnaire
Breast
Disease-specific HRQL will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Year 5
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Year 6
Overall Survival
Year 5
Progression-free survival on next line of therapy (PFS2)
Year 4
Progression-free survival
Year 4
Clinical Benefit Rate
Duration of Response
Objective Response Rate
PK parameter: Plasma concentrations
Time to First Chemotherapy

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Letrozole with Amcenestrant matching placebo Arm
1 of 2
Amcenestrant with Letrozole-matching placebo Arm
1 of 2
Active Control
Experimental Treatment

1068 Total Participants · 2 Treatment Groups

Primary Treatment: Goserelin · Has Placebo Group · Phase 3

Amcenestrant with Letrozole-matching placebo ArmExperimental Group · 4 Interventions: Goserelin, Palbociclib, SAR439859, Letrozole-matching placebo · Intervention Types: Drug, Drug, Drug, Drug
Letrozole with Amcenestrant matching placebo ArmActiveComparator Group · 4 Interventions: Goserelin, Amcenestrant-matching placebo, Palbociclib, Letrozole · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goserelin
FDA approved
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to end of study (approximately 6.5 years)

Who is running the clinical trial?

SanofiLead Sponsor
2,029 Previous Clinical Trials
2,907,301 Total Patients Enrolled
51 Trials studying Breast Cancer
22,652 Patients Enrolled for Breast Cancer
Clinical Sciences & OperationsStudy DirectorSanofi
787 Previous Clinical Trials
1,582,044 Total Patients Enrolled
10 Trials studying Breast Cancer
1,049 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a confirmed diagnosis of ER+/HER2- breast cancer.
You have no performance status.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.