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A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 to 69, Male and Female
Study Type
Treatment
NCD ID
NCT02927249
Protocol IDs
A011502 (primary)
NCI-2016-00233
Study Sponsor
Alliance for Clinical Trials in Oncology

Summary

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Objectives

PRIMARY OBJECTIVES:

I. To compare the effect of aspirin (325 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients.

SECONDARY OBJECTIVES:

I. To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: distant disease-free survival; overall survival, cardiovascular disease.

II. To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients.

III. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients.

IV. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers.

V. To collect measures of lifestyle that are potential pro-inflammatory states and potential modifying factors, such as obesity, stress, and sleep loss.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive aspirin orally (PO) once daily (QD) for five years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually for 5 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

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

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
Georgia CORE

 

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