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A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

NCT02999477•Adrienne G. Waks

View on ClinicalTrials.gov

Summary

This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer. The interventions involved in this study are: * Pembrolizumab (MK-3475; Keytruda™) * Nab-Paclitaxel (Abraxane

Detailed Description

This research study is a Pilot Study, which is the first time investigators are examining this study intervention. In this research study, the investigators are looking at how the participants body and tumor respond to the combination of Nab-paclitaxel and Pembrolizumab. Also, the investigators will be examining the participants tumor tissue to learn more about the disease. The FDA (the U.S. Food and Drug Administration) has not approved Pembrolizumab for this specific disease; but it has been approved in the United States for the treatment of other diseases. The FDA has not approved Nab-paclitaxel as a treatment option for this type of breast cancer; but it has been approved in the United States for the treatment of metastatic breast cancer (breast cancer that has spread to other parts of the body). Pembrolizumab is a medicine that may treat cancer by working with the participant's immune system. The immune system is the body's natural defense against disease. The immune system sends types of cells called "T cells" throughout the body to detect and fight infections and diseases, including cancer. For some types of cancer, the T cells do not work as they should and are prevented from attacking the tumors. Pembrolizumab is thought to work by blocking a protein in the T cells called PD-1 ("programmed death 1"), which then allows these cells and other parts of the immune system to attack tumors. Nab-paclitaxel (Abraxane) is part of a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells by blocking the action of proteins called microtubules. The combination of Pembrolizumab and Nab-paclitaxel is investigational. "Investigational" means that the combination of study drugs is being studied. The study drugs, when given separately, work in different ways to stop the cancer cells from growing and spreading. However, it is not known if giving the two study drugs at the same time will have a better anti-cancer effect than giving each treatment on its own.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically or cytologically confirmed invasive breast cancer.
•Participants must have operable breast cancer, with tumors greater than or equal to 2 cm in size; Participants must not have any evidence of distant metastatic disease. Inflammatory breast cancer is permitted.
•All confirmed invasive disease must have been tested for ER, PR, and HER2 and participants must have hormone receptor-positive, HER2-negative breast cancer (ER\>1% or PR\>1%, AND HER2-negative per ASCO CAP guidelines, 2013).
•Participants with multicentric, multifocal, and/or contralateral cancers are allowed as long as one lesion meets eligibility and no biopsied tumor is HER2+.
•Prior systemic therapy: No prior chemotherapy, biologic therapy, hormonal therapy or investigational therapy for this operable breast cancer.
•Prior radiation therapy: No prior radiation to the ipsilateral breast.
•The participant is ≥18 years old
•The participant has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (see Appendix A)
•Participants must have normal organ and marrow function as defined below:
•* Absolute neutrophil count ≥1500/mm3
+19 more criteria

Exclusion Criteria

•The participant has received prior pembrolizumab or any other anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy, or has participated in any prior studies involving pembrolizumab
•Hypersensitivity to pembrolizumab or any of its excipients.
•The participant has any history or evidence of active, non-infectious pneumonitis or interstitial lung disease.
•The participant has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart Association Class III or IV; see Appendix B), active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, chronic liver or renal disease, or severe malnutrition.
•Concurrent use of potent CYP3A4 inhibitors (see Appendix C), such as ketoconazole and erythromycin, should be avoided during the study treatment with nab-paclitaxel.
•Pregnant women are excluded from this study because pembrolizumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab.
•Active infection requiring intravenous antibiotics at week 1 day 1.

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

February 23, 2017

Primary Completion Date

November 20, 2022

Completion Date

January 8, 2026

Last Updated

January 29, 2026

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Pembrolizumab

DRUG

Nab-Paclitaxel

DRUG

Biopsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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