NCT01612247

Low Dose Chemotherapy With Aspirin in Patients With Breast Cancer After Neoadjuvant Chemotherapy

Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide and Methotrexate and Aspirin	Cyclophosphamide 50 mg PO daily x 28 days, cycles 1-4 Methotrexate 2.5 mg PO twice daily, days 1 and 2 each week x 4 weeks, cycles 1-4 ASA: 325 mg PO daily x 28 days, cycles 3 and 4 Treatment will be given for a total of 4 cycles.

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-02-01
• Completion: 2014-02-01
• First posted: 2012-06-05
• Last updated: 2012-06-05

Locations

3 sites across 1 country: United States