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Protocol Summary


Protocol No.
PSCI-17-032
Prinicipal Investigator
Truica, Cristina
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
A011502
Title
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: THE ABC Trial
Objective
Primary Objective
To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage HER2 negative breast cancer patients.

Secondary Objectives
2.2.1 To compare the effect of aspirin versus placebo in early stage HER2 negative breast cancer patients upon:
a) Distant disease-free survival
b) Overall survival
c) Cardiovascular disease (see Section 11.3)
-To compare the toxicity of aspirin versus placebo in early stage HER2 negative breast cancer patients.
-To assess adherence to aspirin and placebo among early stage HER2 negative breast cancer patients.
-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.
-To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation for whom there is greater benefit of aspirin versus placebo upon iDFS.
Applicable Disease Sites
Breast - Female

Breast - Male
Status
Open
Participating Institutions
Hershey Medical Center

St. Joseph Cancer Center