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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03518242.
PRIMARY OBJECTIVES:
I. Characterize the molecular portrait and subtype prevalence, via targeted exome sequencing, of women presenting with an initial diagnosis of early stage, locally advanced, or metastatic breast cancer in Uganda.
II. Evaluate the potential to use widely available molecular technology to improve the diagnosis of breast cancer in resource-limited settings.
III. Determine the feasibility of an oral regimen for the treatment of locally advanced breast cancer among hormone receptor-positive Ugandan women.
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.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorManoj P. Menon
