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Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer

NCT03573648 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-19

No results posted yet for this study

Summary

Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.

Conditions

Interventions

DRUG

Avelumab

Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.

DRUG

Endocrine therapy

The endocrine therapy given will depend on menopausal status. Premenopausal women will receive tamoxifen AND either Goserelin or Leuprolide: * Tamoxifen (20mg) will be given orally daily x 4 cycles. (Other Names: Nolvadex) * Goserelin (3.6mg) will be given subcutaneously (under the skin) on Day 1 of each cycle x 4 cycles. (Other Names: Zoladex) * Leuprolide (3.75mg) will be given intramuscularly (in the buttock, thigh, or upper arm) on Day 1 of each cycle x 4 cycles. (Other Names: Leuprorelin, Lupron, Eligard) Postmenopausal women will receive letrozole: \- Letrozole (2.5mg) will be given orally daily each cycle x 4 cycles. (Other Names: Femara)

DRUG

Palbociclib

Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Allegheny Health Network

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Cesar A. Santa-Maria, MD, MSCI · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2026-09-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573648 on ClinicalTrials.gov