Overview

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

Status:
Active, not recruiting
Trial end date:
2022-05-24
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborators:
GlaxoSmithKline
National Cancer Institute (NCI)
Treatments:
Capecitabine
Cyclophosphamide
Methotrexate
Criteria
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)