RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT02927249 A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Status

Open

Description

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.

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.

Treatment

Experimental: Aspirin Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity. Placebo Comparator: Placebo Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.

Conditions

Other

Phases

III

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Crozier, Jennifer

Practice

Breast

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center

Eligibility

- Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility - Any ER/progesterone receptor (PgR) status allowed - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed - Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever - Patients must be enrolled within 1 year after diagnosis - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed - No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention - No history of any prior stroke (hemorrhagic or ischemic) - No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors - No history of atrial fibrillation or myocardial infarction - No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) - No chronic (duration > 30 days) daily use of oral steroids - No known allergy to aspirin - No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study - Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use

Nct ID Number

NCT02927249

Secondary Trial ID Number

A011502/ABC

Keywords

Treatment

More Information

clinicaltrials.gov

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