Clinical trial NCT03518242: Molecular Profile of Breast Cancer in Ugandan Patients With Stage IIB-III Breast Cancer
Official title: Defining the Molecular Profile of Breast Cancer in Uganda and Its Clinical Implications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer Female
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Invasive Breast Carcinoma
Prognostic Stage IIB Breast Cancer AJCC v8
Prognostic Stage III Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Prognostic Stage IIIB Breast Cancer AJCC v8
Prognostic Stage IIIC Breast Cancer AJCC v8
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2018-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Distribution of molecular subtypes
timeFrame: Up to 9 months
measure: Sensitivity to polymerase chain reaction (PCR)
timeFrame: Up to 9 months
measure: Specificity of PCR
timeFrame: Up to 9 months
measure: Patient adherence to treatment
timeFrame: Up to 168 days (8 cycles)
measure: Incidence of adverse events
timeFrame: Up to 6 months
measure: Overall Survival
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: New Mulago Hospital
city: Kampala
country: Uganda
facility: Uganda Cancer Institute
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Manoj Menon
role: PRINCIPAL_INVESTIGATOR
References: