Gender
Female
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers
No
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
