TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Chicago
- Enrollment
- 85
- Locations
- 5
- Primary Endpoint
- Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Treatment Arm
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.
Intervention: Cyclophosphamide (Drug)
Treatment Arm
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.
Intervention: Epirubicin (Drug)
Treatment Arm
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.
Intervention: Docetaxel (Drug)
Treatment Arm
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.
Intervention: Carboplatin (Drug)
Treatment Arm
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.
Intervention: Breast Surgery (Procedure)
Treatment Arm
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.
Intervention: Capecitabine (Drug)
Outcomes
Primary Outcomes
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells in the breast. This will be determined by percentage of participants that do not have noticeable cancer cells in the breast after completing the chemotherapy regimen.
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells in the lymph nodes. This will be determined by percentage of participants that do not have noticeable cancer cells in the lymph nodes after completing the chemotherapy regimen.
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells based on stage of breast cancer. This will be determined by percentage of participants that do not have noticeable cancer cells in the lymph nodes after completing the chemotherapy regimen.
Secondary Outcomes
- Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen(10 years from start of treatment)
- Clinical Response(4 - 6 months from start of chemotherapy)
- Side Effects of the Study Pre-surgery Chemotherapy Regimen(After 8 cycles of treatment (24 weeks))
- Progressive Disease(After 8 cycles of treatment (24 weeks))
- Invasive Disease Free Survival (iDFS)(10 years from start of treatment)
- Duration of Response(10 years from start of treatment)