Last updated on February 2019

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


Brief description of study

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 Study 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:
  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.

Clinical Study Identifier: NCT02927249

Contact Investigators or Research Sites near you

Start Over

George S. Howard

Michigan Cancer Specialists
Roseville, MI United States
  Connect »

Tareq Al Baghdadi

Advanced Breast Care Center PLLC
Warren, MI United States
2.44miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Macomb Hematology Oncology PC
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Warren
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Saint John Macomb-Oakland Hospital
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Bhadresh Nayak MD PC-Warren
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, MI United States
5.05miles
  Connect »

George S. Howard

Premier Hematology Oncology Care
Sterling Heights, MI United States
5.05miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Lymphoma Clinic of Michigan
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Ascension Saint John Hospital
Detroit, MI United States
5.61miles
  Connect »

Hadeel Assad

McLaren Cancer Institute-Macomb
Mount Clemens, MI United States
7.13miles
  Connect »

Ding Wang

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, MI United States
8.18miles
  Connect »

George S. Howard

William Beaumont Hospital-Grosse Point
Grosse Pointe, MI United States
8.23miles
  Connect »

George S. Howard

Mitchell Folbe MD PC
Sterling Heights, MI United States
8.97miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Macomb Township
Macomb, MI United States
9.94miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, MI United States
9.94miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.