Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Sponsor
University of Chicago
Study ID
NCT06291064
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.
  • Breast Surgery — PROCEDURE
    Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.
  • Capecitabine — DRUG
    Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Study Details

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.

Key Dates

First listed
Mar 4, 2024
Start date
Mar 18, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2032

Study Design

Enrollment
85 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) [ Time Frame: 4 - 6 months from start of chemotherapy ]

Central Contacts

Find similar trials

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials

Related Studies