Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT02927249|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Node Positive HER2 Negative Breast Cancer||Other: Placebo Drug: Aspirin||Phase 3|
This is a randomized double-blind placebo-controlled phase III trial of aspirin (300 mg daily) in early stage node-positive HER2 negative breast cancer patients. Patients will be randomized 1:1 within stratum defined by: Hormone Receptor status (HR positive vs HR negative), body mass index (<30 vs ≥ 30 kg/m2) and stage (Stage II vs III).
The primary objective of this trial is to compare the effect of aspirin versus placebo upon invasive disease free survival (iDFS).
Primary objective To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients.
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 (see Section11.3)
- To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients.
- To assess adherence to aspirin and placebo among early stage node-positive 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.
Patients are followed up to 10 years after study enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2936 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||April 2021|
Experimental: Arm I (aspirin)
Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
Placebo Comparator: Arm II (Placebo)
Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
- Invasive disease-free survival (iDFS) [ Time Frame: Time from randomization to first occurrence of any one of the following: distant recurrence, locoregional recurrence, ipsilateral or contralateral breast cancer, second primary (non-breast) invasive cancer or death or any cause, assessed up to 5 years ]
- Overall survival (OS) [ Time Frame: Up to 5 years post-randomization ]
- Distant disease free survival (DDFS) [ Time Frame: Time from randomization to the first occurrence of any one of the following events for invasive disease: distant recurrence, second primary (non-breast) invasive cancer or death from any cause, assessed up to 5 years ]
- Incidence of cardiovascular disease (including cerebrovascular events, myocardial infarction, or coronary artery disease requiring stent placement, angioplasty, or bypass surgery) [ Time Frame: Up to 5 years ]
- Incidence of toxicities, graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.3 [ Time Frame: Up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927249
|Contact: Wendy Chen, M.D., MPH||617-632-3800||DFCIABC@PARTNERS.ORG|
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|Study Chair:||Wendy Chen, M.D., MPH||Dana-Farber Cancer Institute|