Study on Palbociclib and Hormone Therapy Before Surgery for Lobular Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT02764541

This clinical trial is exploring how well breast cancer responds to treatment with hormone therapy alone or combined with a drug called Palbociclib before surgery. The study focuses on hormone receptor-positive breast cancer.

Patient Parameters

Parameter	Options

Program Overview

This study is testing a combination of Palbociclib and hormone therapy to see how well they work in treating early-stage hormone receptor-positive breast cancer before surgery. The trial involves 180 participants and includes two phases: an initial 'window treatment' phase with either tamoxifen or letrozole for two weeks, followed by a treatment phase where participants receive either hormone therapy with Palbociclib or hormone therapy alone for 24 weeks. The study aims to compare the effects of these treatments on cancer cell growth and to evaluate the complete response of the cancer to these therapies.

Description

This clinical trial is open to women with early-stage hormone receptor-positive breast cancer. It involves two main parts: a short initial treatment phase and a longer treatment phase. In the first phase, participants will receive either tamoxifen or letrozole for two weeks. In the second phase, participants will be randomly assigned to receive either hormone therapy with Palbociclib or hormone therapy alone for 24 weeks. The study aims to see how these treatments affect cancer cell growth and to measure the complete response of the cancer to these therapies. Participants will need to provide tumor samples at the start and after the initial treatment phase. The study is open to premenopausal and postmenopausal women, with specific criteria for participation.

Eligibility Criteria

Inclusion Criteria

Women aged 18 or older with Stage I to III invasive breast cancer, with a tumor size of at least 1.5 cm.
Cancer must be hormone receptor-positive (ER and/or PR) and HER2 negative.
Premenopausal women must be in chemical menopause and receive LHRH agonists.
Must agree to provide tumor samples at specific points in the study.
Must be able to swallow oral medication.
Must have adequate blood counts and organ function.
Must agree to use effective contraception during and after the study if premenopausal.
Must not be pregnant or breastfeeding.
Must be willing to sign informed consent.

Exclusion Criteria

Cannot be receiving other investigational treatments or have had prior CDK inhibitor therapy.
Cannot have Stage IV breast cancer.
Cannot have a history of severe allergic reactions to similar drugs.
Cannot be taking medications that strongly affect liver enzymes.
Cannot have uncontrolled illnesses or conditions that would interfere with the study.
Cannot be pregnant or breastfeeding.
Cannot have a history of other active cancers, except for certain non-threatening types.
Cannot be HIV-positive and on antiretroviral therapy.
Cannot be receiving hormone replacement therapy or hormonal contraceptives.
Cannot have received hormone therapy within 5 years prior to the current cancer diagnosis.

Locations

FACILITY	ZIP	CITY	STATE
Stamford Hospital	06904	Stamford	Connecticut
Eastern Maine Medical Center	04412	Brewer	Maine
Dana-Farber at St. Elizabeth's Medical Center	02135	Boston	Massachusetts
Beth Israel Deaconess Medical Center	02215	Boston	Massachusetts
Dana-Farber Cancer Institute	02215	Boston	Massachusetts
DF/BWCC at Milford Regional Medical Center	01757	Milford	Massachusetts
DF/BWCC in clinical affiliation with South Shore Hospital	02190	South Weymouth	Massachusetts
Lifespan	02903	Providence	Rhode Island
Sarah Cannon Research Institute	37203	Nashville	Tennessee
Vanderbilt University Medical Center	37232	Nashville	Tennessee

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