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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Olufunmilayo I Olopade, MD — University of Chicago
• Study coordinator: Ilona Siljander, RN
• Email: isiljander@medicine.bsd.uchicago.edu
• Phone: 1-773-702-4298

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.