Clinical Trials /

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy

NCT02927249

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Aspirin in Preventing Recurrence of Cancer in Patients With Node Positive HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy
  • Official Title: A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Clinical Trial IDs

  • ORG STUDY ID: A011502
  • SECONDARY ID: NCI-2016-00233
  • SECONDARY ID: U10CA180821-01
  • NCT ID: NCT02927249

Conditions

  • Node Positive HER2 Negative Breast Cancer

Interventions

DrugSynonymsArms
AspirinArm I (aspirin)

Purpose

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.

Detailed Description

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:

1. Distant disease-free survival

2. Overall survival

3. Cardiovascular disease (see Section11.3)

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

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

4. 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.

5. 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.

Trial Arms

NameTypeDescriptionInterventions
Arm I (aspirin)ExperimentalPatients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
    • Aspirin
Arm II (Placebo)Placebo ComparatorPatients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.

    Eligibility Criteria

    1. Documentation of Disease - Histologic Documentation: Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma within one year of diagnosis and free of recurrence. 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.

    2. Disease status - Any ER/PgR status allowed.

    3. Prior Treatment - Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined the treating physician, is allowed. The last dose of chemotherapy or radiation therapy must be at least 60 days prior to study registration. Concurrent hormonal therapy will be allowed.

    4. Regular NSAID/aspirin use (defined as ≥ 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for one year prior to study entry and throughout the study period. Participants will be encouraged to use acetaminophen for minor pain and fever.

    5. Patients must be enrolled within 1 year after diagnosis.

    6. Age > 18 and < 70 years of age.

    7. ECOG performance status 0-2.

    8. 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.

    9. For patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed.

    10. No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.

    11. No history of any prior stroke (hemorrhagic or ischemic).

    12. No concurrent anticoagulation with warfarin or heparin or clopidogrel or oral direct thrombin inhibitors.

    13. No history of atrial fibrillation or myocardial infarction.

    14. 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).

    15. No chronic (duration >30 days) daily use of oral steroids.

    16. No known allergy to aspirin.

    17. No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

    18. Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use.

    19. Required Initial Laboratory Values Platelet count ≥ 100,000/mm3

    Maximum Eligible Age:69 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure: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
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 5 years post-randomization
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:
    Measure: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
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Alliance for Clinical Trials in Oncology

    Trial Keywords

      Last Updated

      December 29, 2016