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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15 to 24 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My breast cancer is at Stage I to III and the tumor is at least 1.5 cm big.
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My breast cancer is confirmed as invasive lobular or ductal carcinoma.
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I am postmenopausal, having had no periods for at least a year or have had both ovaries removed.
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I am fully active or can carry out light work.
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I have had DCIS in either the same or the opposite breast.
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My breast cancer is hormone receptor positive and HER2 negative.
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I am a woman aged 18 or older.

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

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

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
~3240
Tamoxifen
2005
Completed Phase 4
~29860
Palbociclib
2017
Completed Phase 3
~3760

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,678 Total Patients Enrolled
110 Trials studying Breast Cancer
36,209 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,677 Total Patients Enrolled
141 Trials studying Breast Cancer
22,422 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

Frequently Asked Questions

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

Is participation in this clinical research experiment available to individuals at present?

"Unfortunately, this clinical trial is not presently accepting patients. It was first listed on May 24th 2016 and its last update was July 15th 2022. Nonetheless, 2883 other trials are currently open for recruitment."

Answered by AI

To what maladies is Palbociclib commonly administered?

"Palbociclib is a therapeutic agent recommended to treat breast cancer, as well as post-surgery care, estrogen receptors, and other related issues."

Answered by AI

To what extent is this medical trial being utilized by participants?

"This research endeavour is no longer accepting patients. It was initially posted on May 24th 2016 and the records were most recently updated on July 15th 2022. Individuals looking for other trials can peruse 2596 clinical studies recruiting breast cancer patients, with 287 of those focused specifically on Palbociclib."

Answered by AI

At what number of venues is this medical research being conducted?

"11 medical centres are now participating in this trial, including Eastern Maine Medical Center in Brewer, DF/BWCC at Milford Regional Medical Centre in Milford and Dana-Farber Cancer Institute of Boston."

Answered by AI

Are there any existing research projects concerning Palbociclib?

"Palbociclib was initially researched at Queen Mary Univerity of London in 1994 and since then has been subject to 357 trials. Of the 287 active studies, a significant proportion is being conducted from Brewer, Maine."

Answered by AI

Has the FDA sanctioned Palbociclib for therapeutic utilization?

"The safety of Palbociclib is estimated at level 2 on a 1-3 scale due to the presence of limited safety data and no clinical proof for its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)
Otto Metzger, MD 2016. "Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02764541.
~22 spots leftby Apr 2025
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