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Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

NCT03879577 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-01-21

Study results available
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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.

Conditions

Interventions

DRUG

Docetaxel

Administered to all patients for a minimum of 4 cycles for 12 weeks.

DRUG

Herceptin

Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.

DRUG

FEC

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).

DRUG

Tamoxifen

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

DRUG

Letrozole

Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.

DRUG

LHRH agonist

Administered to all premenopausal patients.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Olufunmilayo I Olopade, MD · University of Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2023-03-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03879577 on ClinicalTrials.gov