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

NCT03879577 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB18-1178
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; breast cancer stage II; Breast Cancer Stage III; Docetaxel; Herceptin; neoadjuvant treatment; nigeria

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Pathologic Response (pCR)

  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 Outcomes (12)

• Number of Participants With Adverse Events

  4-6 months

• Progression-free Survival (PFS)

  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)

  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.

  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.

  From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy

Study Arms (1)

Neoadjuvant taxotere and trastuzumab

EXPERIMENTAL

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: Docetaxel; Drug: Herceptin; Drug: FEC; Drug: Tamoxifen; Drug: Letrozole; Drug: LHRH agonist

Interventions

Docetaxel DRUG

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

Neoadjuvant taxotere and trastuzumab

Herceptin DRUG

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

Also known as: Trastuzumab

Neoadjuvant taxotere and trastuzumab

FEC 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).

Neoadjuvant taxotere and trastuzumab

Tamoxifen DRUG

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

Neoadjuvant taxotere and trastuzumab

Letrozole DRUG

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

Neoadjuvant taxotere and trastuzumab

LHRH agonist DRUG

Administered to all premenopausal patients.

Neoadjuvant taxotere and trastuzumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ages of 18 to 70 years old
• Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
• Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
• Clinical stages IIA -IIIC (AJCC 2009)
• Chemotherapy-naïve patients (for this malignancy)
• Performance status: ECOG performance status 0-1 (Appendix A)
• 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
• Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
• \. 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)
• \. ECHO: Baseline left ventricular ejection fraction of ≥ 55%

You may not qualify if:

• 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.
• Patients with distant metastasis (brain and/or visceral metastasis)
• Serious, uncontrolled, concurrent infection(s).
• Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
• Participation in any investigational drug study within 4 weeks preceding the start of study treatment
• 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.
• Patients with HER2-negative disease

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University College Hospital, Ibadan, Nigeria

Ibadan, Nigeria

Location

Related Publications (1)

• 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.

  PMID: 32628583 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Trastuzumab; Tamoxifen; Letrozole; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins

Results Point of Contact

• Title: Theodore Karrison (Research Professor)
• Organization: University of Chicago

tkarrison@health.bsd.uchicago.edu

(773) 702-2453

Study Officials

• Olufunmilayo I Olopade, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 19, 2019
• Study Start: November 25, 2019
• Primary Completion: March 30, 2023
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2025-08

Locations

NG (1)