Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

— TARMAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291064
• Other study ID #: IRB23-0678
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2032

Study information

• Verified date: February 2024
• Source: University of Chicago
• Contact: Ilona Siljander
• Phone: 773-834-6542
• Email: isiljander1[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: June 2032
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)	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.	4 - 6 months from start of chemotherapy
Primary	Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes)	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.	4 - 6 months from start of chemotherapy
Primary	Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage)	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.	4 - 6 months from start of chemotherapy
Secondary	Side Effects of the Study Pre-surgery Chemotherapy Regimen	Percentage of participants experiencing Grades 3 and 4 blood, gastrointestinal, neurological and cardiovascular toxicities.	After 8 cycles of treatment (24 weeks)
Secondary	Clinical Response	Percentage of participants achieving clinical response (CR and PR) during neoadjuvant period by breast ultrasound	4 - 6 months from start of chemotherapy
Secondary	Progressive Disease	Percentage of participants with progressive disease during pre-surgery treatment period	After 8 cycles of treatment (24 weeks)
Secondary	Invasive Disease Free Survival (iDFS)	Time to cancer returning or death	10 years from start of treatment
Secondary	Duration of Response	Time to cancer worsening or death	10 years from start of treatment
Secondary	Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen	Percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50%.	10 years from start of treatment