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A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with = 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCT ID
NCT02954874
Protocol IDs
S1418 (primary)
NCI-2016-01595
S1418/BR006
Study Sponsor
National Cancer Institute

Summary

This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVES:

I. To compare invasive disease-free survival (IDFS) of patients with triple-negative breast cancer (TNBC) who have either >= 1 cm residual invasive breast cancer and/or positive lymph nodes (> ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 (pembrolizumab) adjuvant therapy compared to no MK-3475 (pembrolizumab), in both the entire study population and also in the PD-L1 positive subset.

SECONDARY OBJECTIVES:

I. To compare the effects of MK-3475 (pembrolizumab) on overall survival (OS) and distant recurrence-free survival (DRFS) between the two randomized arms for the PD-L1 positive patients and then all patients.

II. To assess the toxicity and tolerability of MK-3475 (pembrolizumab) in this patient population with or without radiation therapy.

TERTIARY OBJECTIVES:

I. To examine the association between biomarkers of inflammation and quality of life and patient reported outcomes between the two groups during and at the end of therapy.

II. To examine the long-term and late effects of treatment on patient-reported outcomes.

III. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (OBSERVATION): Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, and every 6 months for 4 years, then annually for 5 years.

ARM II (PEMROLIZUMAB): Patients receive pembrolizumab intravenously (IV) over 30 minutes on days 1 and 22. Courses repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity.

All patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment.

After completion of study treatment, patients are followed up to 10 years.

Treatment Sites in Georgia

Atlanta Cancer Care - Conyers


1498 Klondike Road
Suite 106
Conyers, GA 30094
404-303-3355
www.atlantacancercare.com

Doctors:

Richard A. Carter MD

Atlanta Cancer Care - Decatur


2545 Lawrenceville Highway
Suite 300
Decatur, GA 30033
404-303-3355
www.atlantacancercare.com

Doctors:

Lijo Simpson MD

Atlanta Cancer Care - Stockbridge


7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com

Doctors:

Gurinderjit K. Sidhu MD
Lijo Simpson MD

Augusta Oncology Associates PC-D'Antignac


1303 D'Antignac Street
Suite 1000
Augusta, GA 30901


Cancer Center at DeKalb Medical Center


2675 North Decatur Road
Suite 410
Decatur, GA 30033
404-501-7789
www.dekalbmedical.org

Doctors:

Jayanthi Srinivasiah MD

Cancer Treatment Centers of America


600 Celebrate Life Parkway
Newnan, GA 30265
www.cancercenter.com

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Georgia Cancer Specialists - CenterPointe


1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com

Doctors:

Rodolfo E. Bordoni MD
Pradeep C. Jolly MD

Georgia Cancer Specialists - Macon-Coliseum


308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com

Doctors:

Cheryl F. Jones MD
Premila Malhotra MD

Pearlman Cancer Center at South Georgia Medical Center


2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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