Clinical Trials Directory

Trials / Completed

CompletedNCT03518242

Molecular Profile of Breast Cancer in Ugandan Patients With Stage IIB-III Breast Cancer

Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCyclophosphamideGiven PO
DRUGMethotrexateGiven PO
DRUGCapecitabineGiven PO
PROCEDUREBiospecimen CollectionUndergo biospecimen collection

Timeline

Start date
2018-06-06
Primary completion
2022-05-04
Completion
2022-05-04
First posted
2018-05-08
Last updated
2022-06-08

Locations

2 sites across 1 country: Uganda

Regulatory

Source: ClinicalTrials.gov record NCT03518242. Inclusion in this directory is not an endorsement.