Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Launched by UNIVERSITY OF CHICAGO · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of chemotherapy drugs to see how well they work in treating triple-negative breast cancer in women from Nigeria. The main goal is to find out how many participants achieve a complete response to the treatment, meaning their cancer might be gone after the therapy. Researchers will also look for specific markers in the blood that could help identify if a patient is not responding well to the chemotherapy. The trial will take place at various sites in Nigeria, with support from the University of Chicago for data analysis.

To participate, women must be between 18 and 70 years old and have a confirmed diagnosis of triple-negative breast cancer. Eligible participants should have a tumor that is at least 2 cm in size and have not received any chemotherapy before for this cancer. They need to be in good health overall, without serious medical conditions that could interfere with the study. If eligible, participants can expect to receive the chemotherapy treatment and will be closely monitored throughout the trial, helping researchers learn more about effective treatments for this type of breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women ages of 18 to 70 years old
• • 2. Women who are able and willing to read understand and sign an informed consent document
• • 3. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
• • 4. Patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC). Patients who are low estrogen reception (ER) expression (\< 20%), progesterone receptor (PR) negative and human epidermal growth factor 2 (HER2) negative are eligible.
• • 5. Clinical stages IIA -IIIC (AJCC 2009)
• • 6. Chemotherapy-naïve patients (for this cancer)
• • 7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• • 8. Non-pregnant and not nursing.
• • Granulocyte greater than or equal to 1,500/microliter
• • Platelet count greater than or equal to 100,000/microliter
• • Absolute neutrophil count (ANC) greater than or equal to l500/microliter
• • Hemoglobin greater than or equal to 10g/deciliter
• • Bilirubin less than or equal 1.5 x upper limit of normal
• • aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) less than 2.5 x upper limit of normal
• • 7. Creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation 10. Baseline left ventricular ejection fraction of greater than or equal to 55%
• Exclusion Criteria:
• • 1. Pregnant or lactating women.
• • 2. Patients with distant metastasis (brain and/or visceral metastasis)
• • 3. Serious, uncontrolled, concurrent infection(s).
• • 4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
• • 5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• • 6. Other serious uncontrolled medical conditions that the treating investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.