Recruiting
PHASE2
INTERVENTIONAL
NCT03879577
Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.
Interventions
Name:
Docetaxel
Type:
DRUG
Description:
Administered to all patients for a minimum of 4 cycles for 12 weeks.
Name:
Herceptin
Type:
DRUG
Description:
Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.
Name:
FEC
Type:
DRUG
Description:
Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
Name:
Tamoxifen
Type:
DRUG
Description:
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
Name:
Letrozole
Type:
DRUG
Description:
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
Name:
LHRH agonist
Type:
DRUG
Description:
Administered to all premenopausal patients.
Primary Outcomes
Measure:
Measure the complete pathologic response (pCR)
TimeFrame:
4-6 months
Description:
Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.
Trial Information
NCT ID
NCT03879577
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
University of Chicago
Last Updated
December 15, 2025