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Hormone Therapy

Goserelin for Breast Cancer (AMEERA-5 Trial)

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

AMEERA-5 Trial 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

AMEERA-5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

12-month Progression-free Survival (PFS) Rate

Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30) Domain Scores

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer Specific Module (EORTC QLQ-BR45) Domain Scores

+13 more

AMEERA-5 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Amcenestrant + PalbociclibExperimental Treatment4 Interventions

Participants received amcenestrant 200 mg tablet along with letrozole-matching placebo once daily, continuously and palbociclib 125 mg PO, QD from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death, or study cut-off date, whichever comes first (maximum exposure: 109 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.

Group II: Letrozole + PalbociclibActive Control4 Interventions

Participants received letrozole 2.5 milligrams (mg) capsule along with amcenestrant-matching placebo once daily, continuously and palbociclib 125 mg orally (PO), once daily (QD) from Day 1 to Day 21 of each 28-day treatment cycle until disease progression, death or study cut-off date, whichever comes first (maximum exposure: 112 weeks). Goserelin once every 4 weeks in pre/peri menopausal women and men.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Goserelin

2008

Completed Phase 3

~7100

Palbociclib

2017

Completed Phase 3

~3760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,511,412 Total Patients Enrolled

51 Trials studying Breast Cancer

23,161 Patients Enrolled for Breast Cancer

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,018,231 Total Patients Enrolled

10 Trials studying Breast Cancer

1,049 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions does Goserelin commonly help alleviate?

"Goserelin is a medication that has many applications, including being used as part of radiation therapy and to treat conditions like endometrial thinning, stage t2b carcinoma of the prostate, and tamoxifen."

Answered by AI

How many individuals are enrolling in this clinical trial?

"Presently, this study is not enrolling patients. The clinical trial was initially posted on October 14th 2020 but the most recent update occurred on September 21st 2022. Right now, there are 2695 trials actively recruiting breast cancer patients and 314 Goserelin studies admitting participants."

Answered by AI

Are there any other studies that have been done using Goserelin?

"As of right now, 314 different clinical trials are underway studying Goserelin. 78 of those active trials are in their third phase. The majority of these experiments originate from Shanghai, China; however, there are 21247 total locations running tests for this medication."

Answered by AI

Are participants being signed up for this experiment currently?

"Unfortunately, this particular study is no longer looking for candidates. The trial was originally posted on October 14th 2020 and updated September 21st 2022. However, there are presently 2695 trials actively admitting patients with breast cancer and 314 trials for Goserelin that are still recruiting patients."

Answered by AI

Are there any dangers associated with Goserelin that patients should be made aware of?

"Goserelin safety is estimated to be a 3. This corresponds to it being in Phase 3 of clinical trials, where there is evidence of efficacy as well as multiple rounds of data supporting its safety."

Answered by AI