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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Given PO
Given PO
Given PO
Undergo biospecimen collection
New Mulago Hospital
Kampala, Uganda
Uganda Cancer Institute
Kampala, Uganda
Distribution of molecular subtypes
Will classify Ugandan women into four categories based on molecular subtypes: estrogen receptor (ER) negative (-)/progesterone receptor (PR) - /HER2 - (triple negative), ER-/PR-/HER positive (+) (HER2), ER+/PR+/HER2- (luminal A), and ER/PR+/HER2 + (luminal B) and compare to aggregate data from previously published data on a cohort of African-American women using chi square tests.
Time frame: Up to 9 months
Sensitivity to polymerase chain reaction (PCR)
Sensitivity, defined as the proportion of women with a particular receptor detected by PCR, among those women who had the receptor detected by immunohistochemistry (IHC), to polymerase chain reaction (PCR) will be estimated with 95% confidence intervals (CIs), using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between reverse transcription (RT)-PCR and IHC.
Time frame: Up to 9 months
Specificity of PCR
Specificity, defined as the proportion of women with a receptor not detected by PCR, among women who did not have the receptor detected by IHC, to PCR will be estimated with 95% CIs, using IHC as the gold standard. Will also calculate the percent agreement between PCR and IHC, and compute the kappa statistic with 95% CIs to assess receptor status agreement between RT-PCR and IHC.
Time frame: Up to 9 months
Patient adherence to treatment
Patient adherence as the proportion of women completing 8 cycles of therapy compared to historical controls from the UCI cancer registry database using chi square tests
Time frame: Up to 168 days (8 cycles)
Incidence of adverse events
Will describe the extent of adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Will also compare patient adherence and adverse events using chi square tests and compare survival using log-rank tests.
Time frame: Up to 6 months
Overall Survival
Will use Kaplan-Meier methodology.
Time frame: Up to 1 year
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