Clinical trial NCT06291064: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)
timeFrame: 4 - 6 months from start of chemotherapy
measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes)
timeFrame: 4 - 6 months from start of chemotherapy
measure: Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage)
timeFrame: 4 - 6 months from start of chemotherapy
Secondary outcomes:
measure: Side Effects of the Study Pre-surgery Chemotherapy Regimen
timeFrame: After 8 cycles of treatment (24 weeks)
measure: Clinical Response
timeFrame: 4 - 6 months from start of chemotherapy
measure: Progressive Disease
timeFrame: After 8 cycles of treatment (24 weeks)
measure: Invasive Disease Free Survival (iDFS)
timeFrame: 10 years from start of treatment
measure: Duration of Response
timeFrame: 10 years from start of treatment
measure: Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen
timeFrame: 10 years from start of treatment
Other outcomes:
Locations:
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex
state: Osun
Study officials:
affiliation: University of Chicago
name: Olufunmilayo Olopade, MD
role: STUDY_CHAIR
References: