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CDK4/6 Inhibitor

Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Led By Senthilkumar Damodaran, MD
Research Sponsored by M.D. Anderson Cancer Center
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 up to 30 days
Awards & highlights

Study Summary

This trial is testing how well three different drugs work when given together to treat patients with a specific type of hormone receptor-positive breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days 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
Changes in cancer antigens (CA) 15-3 tumor marker
Circulating tumor deoxyribonucleic acid (ctDNA) ESR1 mutant allele fraction (MAF) and kinetics
Overall survival (OS)
+2 more

Side effects data

From 2012 Phase 3 trial • 514 Patients • NCT00256698
12%
Arthralgia
11%
Fatigue
9%
Nausea
8%
Hot flush
6%
Diarrhoea
6%
Constipation
5%
Urinary tract infection
5%
Dyspnoea
5%
Vomiting
4%
Cough
4%
Back pain
3%
Musculoskeletal pain
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Renal Failure
1%
Cardiac Failure
1%
Femur Fracture
1%
Pneumonia
1%
Sepsis
1%
Back Pain
1%
Dizziness
1%
Syncope
1%
Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fulvestrant + Anastrozole
Anastrozole

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ribociclib, palbociclib, abemaciclib, fulvestrant)Experimental Treatment4 Interventions
Patients receive ribociclib PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive fulvestrant IM for 2 injections over 1-2 minutes each on days 1 and 15 of cycle 1 and day 2 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (ribociclib, palbociclib, abemaciclib, letrozole)Active Control5 Interventions
Patients receive ribociclib orally PO QD, palbociclib PO QD on days 1-21, and/or abemaciclib PO BID on days 1-28. Patients also receive letrozole PO QD or anastrozole PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3700
Abemaciclib
2019
Completed Phase 2
~1550
Palbociclib
2017
Completed Phase 3
~3720
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,642 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,445 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Senthilkumar Damodaran, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04256941 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04256941 — Phase 2

Frequently Asked Questions

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

Are we still enrolling people in this experiment?

"Yes, this study is still recruiting patients. According to the information on clinicaltrials.gov, the trial was originally posted on May 31st, 2019 and was last updated on October 25th, 2022."

Answered by AI

What is the primary disease that Fulvestrant has been shown to improve?

"If a patient's cancer progresses despite tamoxifen therapy, fulvestrant may be an effective treatment option."

Answered by AI

What is the total sample size for this clinical trial?

"That is accurate. The clinicaltrials.gov website says that this research is currently looking for subjects. It was originally posted on 5/31/2019, with the most recent update on 10/25/2022. They want 124 individuals from 1 location."

Answered by AI

Is Fulvestrant a common prescription medication?

"449 different Fulvestrant studies are currently active with 85 of them being in Phase 3. Even though a large quantity of the research is coming out of Shanghai, China, there are 24073 total locations where Fulvestrant trials are taking place."

Answered by AI

Has Fulvestrant been cleared by the FDA for patient use?

"Although there is some evidence backing Fulvestrant's safety, it did not receive a higher score due to the lack of clinical data demonstrating its efficacy."

Answered by AI
~1 spots leftby Mar 2025