Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Official title

TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

Overview

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC). All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Interventions

• Drug Cyclophosphamide
  Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.
• Drug Epirubicin
  Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.
• Drug Docetaxel
  Docetaxel is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Carboplatin. Dosing will start after treatment with Epirubicin and Cyclophosphamide (EC) is completed.
• Drug Carboplatin
  Carboplatin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Docetaxel. Dosing will start after treatment with EC is completed.
• Procedure Breast Surgery
  Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.
• Drug Capecitabine
  Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Primary outcome measures

• Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) [Time frame: 4 - 6 months from start of chemotherapy]
• Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes) [Time frame: 4 - 6 months from start of chemotherapy]
• Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage) [Time frame: 4 - 6 months from start of chemotherapy]

Secondary outcome measures (6)

• Side Effects of the Study Pre-surgery Chemotherapy Regimen [Time frame: After 8 cycles of treatment (24 weeks)]
• Clinical Response [Time frame: 4 - 6 months from start of chemotherapy]
• Progressive Disease [Time frame: After 8 cycles of treatment (24 weeks)]
• Invasive Disease Free Survival (iDFS) [Time frame: 10 years from start of treatment]
• Duration of Response [Time frame: 10 years from start of treatment]
• Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen [Time frame: 10 years from start of treatment]

Eligibility criteria

Inclusion criteria

• Women ages of 18 to 70 years old
• Women who are able and willing to read understand and sign an informed consent document
• Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
• 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.
• Clinical stages IIA -IIIC (AJCC 2009)
• Chemotherapy-naïve patients (for this cancer)
• Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• 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

• Pregnant or lactating women.
• Patients with distant metastasis (brain and/or visceral metastasis)
• Serious, uncontrolled, concurrent infection(s).
• Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Nigeria · 4 centers

• Lagos State University Teaching Hospital — Ikeja
• Lagos University Teaching Hospital — Yaba
• Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife
• University of Ibadan Hospital — Ibadan

Identifiers

NCT: NCT06291064 · IRB23-0678

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗