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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer Female; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Invasive Breast Carcinoma; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Treatments: Drug: Capecitabine; Drug: Methotrexate; Drug: Cyclophosphamide; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03518242

NCI-2018-02609 (Registry Identifier)

RG1001403 (Other Identifier)

U025

8424 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with any menopausal status, with newly diagnosed, locally advanced and histologically confirmed invasive breast cancer (Patients with stage 2B [i.e. T3N0], 3A, 3B, and 3C disease)
• Absolute neutrophil count (ANC) > 1500/mm
• Hemoglobin > 9 g/dL
• Platelets >=100,000 cells/mm^3
• Total bilirubin =< 1.2 mg/dL
• International normalized ratio (INR) =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x ULN
• Serum alkaline phosphatase should be 1.5 x ULN
• Patients with positive hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, INR, activated partial thromboplastin time (aPTT), and alkaline phosphatase on at least two consecutive occasions, separated by at least 1 week
• Adequate renal function with serum creatinine < 1.5 x ULN
• Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
• Women of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment
• Left ventricular ejection fraction >= 50%
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Signed written informed consent

Exclusion criteria

• A treatment-free interval of < 6 months with previous chemotherapy
• Active, unresolved infection or systemic disease (e.g. pulmonary or metabolic disease)
• Patients with active liver disease
• Patients with active cardiac disease, including congestive heart failure (or therapy specifically for congestive heart failure [CHF])
• Patients with uncontrolled hypertension (diastolic >100 mmHg or systolic > 160 mmHg)
• Known hypersensitivity to any of the drugs
• Significant current illness (including psychiatric illness)
• Any social situations or other conditions that in the opinion of the investigator limit compliance with study requirements
• Calcium imbalance
• Patients that have received treatment with sorividine or brividine (herpex) or any related analogue within 4 weeks prior to starting the investigational product (IP)
• Eye problems
• Patients on any of the following medications: acitretin, azathioprine, Bacillus Calmette Guerin (BCG) (intravesicular), belimumab, deferiprone, diphyrone, etanercept, foscarnet, gimeracil, levetriracetam, natalizumab, pimercrolimus, retinoids, sulfazalazine, tacrolimus tofacitininb
• Patients receiving any anticoagulation (including warfarin)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment (Specimen collection, chemotherapy)

Experimental group

Description:

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 PO daily on days 1-21, methotrexate PO QD on days 1, 8, and 15, and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity.

Treatment:

Drug: Cyclophosphamide

Drug: Methotrexate

Procedure: Biospecimen Collection

Drug: Capecitabine