Evaluating the effectiveness of Taxotere and Trastuzumab in Nigerian women with HER2-positive breast cancer

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

This study is testing if a combination of two cancer drugs, Taxotere and Trastuzumab, can help Nigerian women with HER2-positive breast cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: University of Chicago (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Ibadan)
• Trial ID: NCT03879577 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial aims to assess the response rate of neo-adjuvant treatment using Docetaxel and Trastuzumab in women with HER2-positive breast cancer in Nigeria. The study will involve chemotherapy and hormonal treatment-naïve patients with significant tumor size, specifically those with clinical stages IIA to IIIC. Participants will receive a combination of chemotherapy agents and hormonal therapy, with the goal of determining the effectiveness of this treatment regimen in this specific population.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 70 years with HER2-positive breast cancer who have not previously undergone chemotherapy or hormonal treatment.

Not a fit: Patients with breast cancer who have already received chemotherapy or hormonal treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for Nigerian women with HER2-positive breast cancer.

How similar studies have performed: Other studies have shown success with similar neo-adjuvant approaches in HER2-positive breast cancer, indicating potential for positive outcomes in this trial.

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

Where this trial is running

Ibadan

• University College Hospital, Ibadan, Nigeria — Ibadan, Nigeria (Recruiting)

Study contacts

• Principal investigator: Olufunmilayo I Olopade, MD — University of Chicago
• Study coordinator: Ilona Siljander, RN

Conditions Breast Cancer; Breast Cancer Female; HER2-positive Breast Cancer; Breast Cancer Stage II; Breast Cancer Stage III; breast cancer; breast cancer stage II; Docetaxel