Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer (TARMAC)

The University of Chicago

Status and phase: Not yet enrolling; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Epirubicin; Drug: Docetaxel; Procedure: Breast Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06291064

IRB23-0678

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

9. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Participants will receive epirubicin and cyclophosphamide every three weeks for a total of 12 weeks followed by 3-weekly docetaxel for 12 weeks and carboplatin every three weeks for a total of 12 weeks. All premenopausal participants will receive luteinizing hormone-releasing hormone (LHRH) agonist goserelin (Zoladex) for contraception and fertility preservation.

Treatment:

Procedure: Breast Surgery

Drug: Docetaxel

Drug: Epirubicin

Drug: Capecitabine

Drug: Cyclophosphamide

Drug: Carboplatin