Study on Neoadjuvant Endocrine Therapy, Palbociclib, and Avelumab for Estrogen Receptor Positive Breast Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT03573648

This clinical trial is testing a combination of treatments, including endocrine therapy, palbociclib, and avelumab, to see if they can effectively treat estrogen receptor positive breast cancer before surgery.

Patient Parameters

Parameter	Options

Program Overview

The study involves patients with estrogen receptor positive breast cancer who will first receive either standard endocrine therapy or a combination of endocrine therapy and palbociclib. After one cycle of treatment, all patients will receive avelumab for three more cycles. The aim is to see if this combination can help control the cancer before patients undergo breast surgery.

Description

Participants in this study will receive either standard endocrine therapy or a combination of endocrine therapy and palbociclib for the first 28 days. After this period, a biopsy, MRI, and blood tests will be conducted. Then, all participants will receive avelumab along with their initial treatment for three more cycles, each lasting 28 days. The type of endocrine therapy will depend on whether the participant is premenopausal or postmenopausal. Premenopausal women will take tamoxifen daily and receive either Leuprolide or Goserelin injections. Postmenopausal women will take letrozole daily. The treatment will continue as long as the cancer does not progress and the patient can tolerate the therapy. If the cancer grows by 25% or more, the treatment will stop, and the patient will undergo surgery. Otherwise, after completing all four cycles, patients will have an MRI and then proceed to surgery.

Eligibility Criteria

Inclusion Criteria

Have Stage II-III estrogen receptor positive breast cancer.
Tumor must be detectable by ultrasound or touch.
Be 18 years or older.
Have a performance status score of 1 or less, indicating good overall health.
Have adequate organ and bone marrow function based on recent tests.
Agree to use effective contraception during the study and for 30 days after.
Women of childbearing potential must have a negative pregnancy test before starting the study.
Be able to understand and sign a consent form to participate.

Exclusion Criteria

Have metastatic or inflammatory breast cancer.
Not be sensitive to endocrine therapy, making this approach unsuitable.
Have had endocrine therapy in the last 10 years.
Have used CDK4/6 inhibitors or immune checkpoint inhibitors before.
Be taking SSRIs or certain other medications unless approved by the study chair.
Be on other investigational drugs or immunosuppressive therapy recently.
Have allergies to similar drugs used in the study.
Have had another cancer diagnosis or treatment within the last 3 years, except for certain skin or cervical cancers.
Have autoimmune diseases or uncontrolled illnesses that could interfere with the study.
Have had a recent vaccination or organ transplant.
Be pregnant or nursing.

Locations

FACILITY	ZIP	CITY	STATE
University of Alabama at Birmingham	35233	Birmingham	Alabama
Sibley Memorial Hospital	20016	Washington D.C.	District of Columbia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	21287	Baltimore	Maryland
Allegheny Health Network	15224	Pittsburgh	Pennsylvania

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