NCT03879577

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

Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer
• Breast Cancer Female
• HER2-positive Breast Cancer
• Breast Cancer Stage II
• Breast Cancer Stage III

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-25
• Primary completion: 2023-03-30
• Completion: 2026-09-30
• First posted: 2019-03-19
• Last updated: 2026-01-21
• Results posted: 2026-01-21

Locations

1 site across 1 country: Nigeria

Regulatory

• FDA-regulated drug study