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Hormone Therapy

Ribociclib + Aromatase Inhibitors (and Goserelin for Premenopausal Women) for Breast Cancer (AMALEE Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23.8 months
Awards & highlights

AMALEE Trial Summary

This trial is studying whether a lower dose of the drug ribociclib, when given with another cancer drug and goserelin (in premenopausal women), can help to treat breast cancer.

Who is the study for?
This trial is for women with advanced breast cancer that can't be cured by surgery. They should have hormone receptor-positive, HER2-negative tumors and no prior therapy for advanced disease. Participants must not be pregnant, willing to use contraception, and have a good performance status (able to carry out daily activities). Those with certain heart conditions or recent other treatments are excluded.Check my eligibility
What is being tested?
The study tests two doses of Ribociclib (400 mg vs. 600 mg) taken orally in cycles of 3 weeks on/1 week off, combined with aromatase inhibitors and goserelin in premenopausal women. The goal is to see if the lower dose reduces side effects without losing effectiveness against breast cancer.See study design
What are the potential side effects?
Important risks include QT interval prolongation which affects heart rhythm, neutropenia which lowers white blood cell count increasing infection risk, and potential liver issues. Side effects may vary between individuals.

AMALEE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My breast cancer is ER or PgR positive, confirmed by a recent tissue test.
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My breast cancer is HER2-negative based on the latest tests.
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My breast cancer has spread and cannot be cured with surgery or radiation.

AMALEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23.8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23.8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Change From Baseline in QTc (With Fridericia's Correction) at Cycle 1 Day 15 (at 2 Hours Post-dose)
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
+5 more

AMALEE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ribociclib 400 mgExperimental Treatment4 Interventions
Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
Group II: Ribociclib 600 mgActive Control4 Interventions
Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anastrozole
2019
Completed Phase 4
~10300
Letrozole
2002
Completed Phase 4
~3240
Ribociclib
2018
Completed Phase 3
~2330
Goserelin
2008
Completed Phase 3
~4110

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,011 Total Patients Enrolled
87 Trials studying Breast Cancer
37,436 Patients Enrolled for Breast Cancer

Media Library

Goserelin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03822468 — Phase 2
Breast Cancer Research Study Groups: Ribociclib 600 mg, Ribociclib 400 mg
Breast Cancer Clinical Trial 2023: Goserelin Highlights & Side Effects. Trial Name: NCT03822468 — Phase 2
Goserelin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03822468 — Phase 2

Frequently Asked Questions

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

Is there a compendium of prior research involving Ribociclib?

"The first research involving ribociclib was conducted in 1995 at the National Institutes of Health Clinical Center. To date, 381 studies have been concluded while 253 active trials are currently ongoing, with a noticeable concentration occurring in Houston, TX."

Answered by AI

Is this trial still accepting new participants?

"Clinicaltrials.gov reports that this particular medical trial is no longer in need of participants, despite being initially posted on June 11th 2019 and last edited September 5th 2021. However, there are 2 849 other clinical studies still actively seeking patients."

Answered by AI

In which medical ailments does Ribociclib demonstrate efficacy?

"Ribociclib is mainly prescribed for the treatment of breast cancer. It can also prove beneficial in treating radiation therapy, endometrial thinning, and stage t2b carcinoma of the prostate."

Answered by AI

Are there outposts in North America where this research project is being conducted?

"The research team is based at Northwest Cancer Ctr in Houston, Texas, Mount Sinai School of Medicine CFTY720D2306 in New york City and Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50) in Greenwood Village, Colorado as well as 21 other centers."

Answered by AI

How many participants has the clinical trial enrolled thus far?

"Unfortunately, this trial has since finished recruitment. It was initially posted on June 11th 2019 and last updated September 5th 2022. However, individuals with breast cancer have 2596 alternative clinical trials to choose from while those interested in Ribociclib can look at 253 other potential studies."

Answered by AI

Is there any potential risk associated with the utilization of Ribociclib?

"Ribociclib is thought to be moderately safe with a score of 2; data suggests that the medication has some safety protocols in place, however there is no evidence yet to support its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
2019. "Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03822468.
~64 spots leftby Apr 2025
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