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

NCT ID: NCT03879577

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2026-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

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

Herceptin

Intervention Type: DRUG

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

FEC

Intervention Type: DRUG

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).

Tamoxifen

Intervention Type: DRUG

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

Letrozole

Intervention Type: DRUG

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

LHRH agonist

Intervention Type: DRUG

Administered to all premenopausal patients.

Interventions

Docetaxel

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

Intervention Type: DRUG

Herceptin

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

Intervention Type: 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).

Intervention Type: DRUG

Tamoxifen

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

Intervention Type: DRUG

Letrozole

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

Intervention Type: DRUG

LHRH agonist

Administered to all premenopausal patients.

Intervention Type: DRUG

Other Intervention Names

Trastuzumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olufunmilayo I Olopade, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University College Hospital, Ibadan, Nigeria

Ibadan, , Nigeria

Countries

Nigeria

References

Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043.

Reference Type: DERIVED

PMID: 32628583 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB18-1178

Identifier Type: -

Identifier Source: org_study_id