← Back to Search

Hormone Therapy

Palbociclib + Endocrine Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Otto Metzger, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have Stage I to III histologically confirmed invasive carcinoma of the breast with a minimum tumor size of at least 1.5 cm
Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma for the window phase
Must not have
Patients with Stage IV breast cancer are not eligible
Pregnant women, or women of childbearing potential without a negative pregnancy test within 7 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a combination of endocrine therapy and the drug palbociclib is better than endocrine therapy alone as a treatment for hormone receptor positive breast cancer.

Who is the study for?
This trial is for women aged 18+ with hormone receptor positive, HER2 negative invasive breast cancer that hasn't spread beyond Stage III. Participants must have a tumor size of at least 1.5 cm and be able to take oral medication. Men, pregnant women, those with certain other cancers or illnesses, and anyone who has had prior CDK inhibitor treatment or endocrine therapy within the last five years cannot join.
What is being tested?
The PELOPS study is testing how well breast cancer responds to preoperative endocrine therapy alone versus in combination with Palbociclib. It's designed to compare the effectiveness of these treatments in shrinking tumors before surgery in patients with hormone receptor positive breast cancer.
What are the potential side effects?
Palbociclib can cause side effects like low white blood cell counts (increasing infection risk), fatigue, nausea, sore mouth, hair thinning, diarrhea and vomiting. Endocrine therapies such as Letrozole and Tamoxifen may lead to hot flashes, joint pain or stiffness, weakness, bone loss and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is at Stage I to III and the tumor is at least 1.5 cm big.
Select...
My breast cancer is confirmed as invasive lobular or ductal carcinoma.
Select...
I am postmenopausal, having had no periods for at least a year or have had both ovaries removed.
Select...
I am fully active or can carry out light work.
Select...
I have had DCIS in either the same or the opposite breast.
Select...
My breast cancer is hormone receptor positive and HER2 negative.
Select...
I am a woman aged 18 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My breast cancer is not Stage IV.
Select...
I am not pregnant or have a recent negative pregnancy test.
Select...
I am not on any hormone therapy.
Select...
I am not taking strong medication that affects liver enzymes.
Select...
I do not have any uncontrolled illnesses that would affect my participation.
Select...
I have been treated with a CDK inhibitor before.
Select...
I am not on HIV medication.
Select...
I haven't had hormone therapy in the last 5 years before my current cancer diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15 to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15 to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase
Pathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase
Secondary study objectives
Change in RCB Index Between Arm C and Arm D During the Treatment Phase
Number of Participants With RCB Response in Arm C and Arm D During the Treatment Phase
Odds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Tamoxifen Followed By Endocrine Therapy and PalbociclibExperimental Treatment3 Interventions
Tamoxifen is given in the Window of Treatment phase for 2 weeks followed by Endocrine Therapy in combination with Palbociclib for 24 weeks.
Group II: Letrozole Followed By Endocrine Therapy and PalbociclibExperimental Treatment3 Interventions
Letrozole is given in the Window of Treatment phase for 2 weeks followed by Endocrine Therapy in combination with Palbociclib for 24 weeks.
Group III: Arm B Letrozole Followed By Endocrine TherapyExperimental Treatment2 Interventions
Letrozole is given in the Window of Treatment phase for 2 weeks followed by Endocrine Therapy for 24 weeks.
Group IV: Arm A Tamoxifen followed by Endocrine TherapyExperimental Treatment2 Interventions
Tamoxifen is given in the Window of Treatment phase for 2 weeks followed by Endocrine Therapy for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endocrine Therapy
2013
Completed Phase 3
~680
Letrozole
2002
Completed Phase 4
~3590
Tamoxifen
2005
Completed Phase 4
~30110
Palbociclib
2017
Completed Phase 3
~3790

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,092 Total Patients Enrolled
113 Trials studying Breast Cancer
41,151 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,042 Total Patients Enrolled
144 Trials studying Breast Cancer
20,017 Patients Enrolled for Breast Cancer
Otto Metzger, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
235 Total Patients Enrolled
2 Trials studying Breast Cancer
167 Patients Enrolled for Breast Cancer

Media Library

Letrozole (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02764541 — Phase 2
Breast Cancer Research Study Groups: Arm B Letrozole Followed By Endocrine Therapy, Tamoxifen Followed By Endocrine Therapy and Palbociclib, Letrozole Followed By Endocrine Therapy and Palbociclib, Arm A Tamoxifen followed by Endocrine Therapy
Breast Cancer Clinical Trial 2023: Letrozole Highlights & Side Effects. Trial Name: NCT02764541 — Phase 2
Letrozole (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02764541 — Phase 2
~21 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top