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

January 2, 2026 updated by: University of Chicago

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
      • Ibadan, Nigeria
        • University College Hospital, Ibadan, Nigeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women ages of 18 to 70 years old
  2. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  3. Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
  4. Clinical stages IIA -IIIC (AJCC 2009)
  5. Chemotherapy-naïve patients (for this malignancy)
  6. Performance status: ECOG performance status 0-1 (Appendix A)
  7. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
  8. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT < 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator)

9. ECHO: Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

  1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
  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 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.
  7. Patients with HER2-negative disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant taxotere and trastuzumab

Investigators will give patients docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done.

Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive

Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks.

Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study.
Drug: LHRH agonist
Administered to all premenopausal patients.
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: 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.
Other Names:
  • Trastuzumab
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Pathologic Response (pCR)
Time Frame: 4-6 months
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.
4-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 4-6 months
Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.
4-6 months
Progression-free Survival (PFS)
Time Frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Time from enrollment to disease recurrence or death from any cause.
From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Duration of Response (DOR)
Time Frame: Up to 10 years
Time from pathological complete response to disease recurrence or death
Up to 10 years
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy.
Time Frame: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy.
Time Frame: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy.
Time Frame: From start date of therapy to 6 months post-therapy
Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy.
Time Frame: From start date of therapy to 6 months post-therapy
Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC
Time Frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).
From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Blood Concentrations of Herceptin SC Given in Combination With Docetaxel
Time Frame: 21 days
Blood concentrations of Herceptin SC at multiple time points using the peak exposure
21 days
Drug Plasma Concentration of Herceptin SC Given in Combination With FEC
Time Frame: 21 days
Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH
21 days
The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients
Time Frame: Through study completion an average of two years
The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%.
Through study completion an average of two years
The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients
Time Frame: Through study completion an average of two years
The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.
Through study completion an average of two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Olufunmilayo I Olopade, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Actual)

March 30, 2023

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-1178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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