Summary

for people ages 18-69 (full criteria)
at San Francisco, California and other locations
study started
Niharika Dixit

Description

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.

Official Title

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

Details

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.

Secondary objectives

  1. To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon:
  2. Distant disease-free survival
  3. Overall survival
  4. Cardiovascular disease (see Section11.3)
  5. To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients.
  6. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients.
  7. 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.
  8. 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.

Keywords

Node Positive HER2 Negative Breast Cancer Breast Neoplasms Aspirin

Eligibility

For people ages 18-69

  • 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

Locations

  • Zuckerberg San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • University Oncology Associates accepting new patients
    Fresno California 93701 United States
  • California Pacific Medical Center-Pacific Campus accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente-San Francisco accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco California 94080 United States
  • California Cancer Center - North Fresno accepting new patients
    Fresno California 93720 United States
  • Kaiser Permanente-Fresno accepting new patients
    Fresno California 93720 United States
  • Bay Area Breast Surgeons Inc accepting new patients
    Emeryville California 94608 United States
  • Epic Care Partners in Cancer Care accepting new patients
    Emeryville California 94608 United States
  • Alta Bates Summit Medical Center - Summit Campus accepting new patients
    Oakland California 94609 United States
  • Bay Area Tumor Institute accepting new patients
    Oakland California 94609 United States
  • Alta Bates Summit Medical Center-Herrick Campus accepting new patients
    Berkeley California 94704 United States
  • Kaiser Permanente-Richmond accepting new patients
    Richmond California 94801 United States
  • Mills-Peninsula Medical Center accepting new patients
    Burlingame California 94010 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro California 94577 United States
  • Kaiser Permanente-San Rafael accepting new patients
    San Rafael California 94903 United States
  • Kaiser San Rafael-Gallinas accepting new patients
    San Rafael California 94903 United States
  • Eden Hospital Medical Center accepting new patients
    Castro Valley California 94546 United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez California 94553-3156 United States
  • Kaiser Permanente-Redwood City accepting new patients
    Redwood City California 94063 United States
  • Kaiser Permanente-Walnut Creek accepting new patients
    Walnut Creek California 94596 United States
  • Sutter Cancer Research Consortium accepting new patients
    Novato California 94945 United States
  • Palo Alto Medical Foundation Health Care accepting new patients
    Palo Alto California 94301 United States
  • Epic Care-Dublin accepting new patients
    Dublin California 94568 United States
  • Kaiser Permanente-Vallejo accepting new patients
    Vallejo California 94589 United States
  • Sutter Solano Medical Center/Cancer Center accepting new patients
    Vallejo California 94589 United States
  • Kaiser Permanente-Fremont accepting new patients
    Fremont California 94538 United States
  • Palo Alto Medical Foundation-Fremont accepting new patients
    Fremont California 94538 United States
  • Palo Alto Medical Foundation-Camino Division accepting new patients
    Mountain View California 94040 United States
  • Palo Alto Medical Foundation-Gynecologic Oncology accepting new patients
    Mountain View California 94040 United States
  • Palo Alto Medical Foundation-Sunnyvale accepting new patients
    Sunnyvale California 94086 United States
  • Kaiser Permanente Medical Center - Santa Clara accepting new patients
    Santa Clara California 95051 United States
  • Kaiser Permanente-Deer Valley Medical Center accepting new patients
    Antioch California 94531 United States
  • Northbay Cancer Center accepting new patients
    Vacaville California 95687 United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville accepting new patients
    Vacaville California 95687 United States
  • Kaiser Permanente Medical Center-Vacaville accepting new patients
    Vacaville California 95688 United States
  • Saint Helena Hospital accepting new patients
    Saint Helena California 94574 United States
  • Kaiser Permanente-Santa Teresa-San Jose accepting new patients
    San Jose California 95119 United States
  • Kaiser Permanente-Santa Rosa accepting new patients
    Santa Rosa California 95403 United States
  • Saint Joseph Heritage Healthcare-Santa Rosa accepting new patients
    Santa Rosa California 95403 United States
  • Sutter Pacific Medical Foundation accepting new patients
    Santa Rosa California 95403 United States
  • Mercy UC Davis Cancer Center accepting new patients
    Merced California 95340 United States
  • Palo Alto Medical Foundation-Santa Cruz accepting new patients
    Santa Cruz California 95065 United States

Details

Status
accepting new patients
Start Date
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT02927249
Phase
Phase 3
Lead Scientist
Niharika Dixit
Study Type
Interventional
Last Updated
August 6, 2018