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