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Trial record 1 of 1 for:    A011502
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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

This study is currently recruiting participants.
Verified September 2017 by Alliance for Clinical Trials in Oncology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02927249
First Posted: October 7, 2016
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
United States Department of Defense
Bayer
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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.

Condition Intervention Phase
Node Positive HER2 Negative Breast Cancer Other: Placebo Drug: Aspirin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2936
Study Start Date: December 2016
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (aspirin)
Patients receive aspirin PO QD for five years in the absence of disease progression or unacceptable toxicity.
Drug: Aspirin
Given PO
Placebo Comparator: Arm II (Placebo)
Patients receive placebo PO QD for five years in the absence of disease progression or unacceptable toxicity.
Other: Placebo
Given PO

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927249


Contacts
Contact: Wendy Chen, M.D., MPH 617-632-3800 DFCIABC@PARTNERS.ORG

  Show 1053 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
United States Department of Defense
Bayer
Investigators
Study Chair: Wendy Chen, M.D., MPH Dana-Farber Cancer Institute
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02927249     History of Changes
Other Study ID Numbers: A011502
NCI-2016-00233 ( Registry Identifier: Clinical Trial Reporting Program )
U10CA180821-01 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2016
First Posted: October 7, 2016
Last Update Posted: October 2, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics