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Brief Title: Molecular Profile of Breast Cancer in Ugandan Patients With Stage IIB-III Breast Cancer
Official Title: Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications
Study ID: NCT03518242
Brief Summary: This phase I trial studies the molecular profile of breast cancer in Ugandan patients with stage IIB-III breast cancer. Creating a molecular profile of breast cancer my help doctors learn more about biological factors associated with breast cancer in Ugandan patients with as well as measure the benefits of locally available diagnostic studies and the possibility of providing treatment via oral medication.
Detailed Description: OUTLINE: SPECIMEN COLLECTION: Patients undergo collection of tumor tissue and peripheral blood samples for analysis via next generation sequencing to identify novel pathways in the pathogenesis of breast cancer. TREATMENT: Patients are invited to participate in a treatment study. Patients receive cyclophosphamide orally (PO) daily on days 1-21, methotrexate PO QD on days 1, 8, and 15, and capecitabine PO twice daily (BID) on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed up for 24 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
New Mulago Hospital, Kampala, , Uganda
Uganda Cancer Institute, Kampala, , Uganda
Name: Manoj Menon
Affiliation: Fred Hutchinson Cancer Center
Role: PRINCIPAL_INVESTIGATOR