Cancer
Conditions
Interventions
Sponsors
University of Chicago
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women ages 18 to 70 years old 2. Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (= 2cm) 3. Measurable breast tumor using ultrasonography (= 2cm) 4. Patients with histologically confirmed carcinoma of the female breast with positive HER2 status 5. Clinical stages IIA –IIIC. (AJCC 2009) (Appendix A) 6. Chemotherapy-naïve patients (for this malignancy) 7. Performance status: ECOG performance status 0-3 (Appendix B) 8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receiving LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. Women of childbearing potential do not use 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 will agree to continue using an acceptable form of contraception for 7 months from the last drug administration date (Herceptin). 2. Patients with distant metastasis 3. Serious, uncontrolled, concurrent infection(s). 4. Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patients who have received tamoxifen or raloxifene for chemoprevention (e.g., Breast Cancer Prevention Trial or other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled in this study. 5. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS) 6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response in the breast at surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AE) and serious adverse drug reactions (SAE), including clinical laboratory values, vital signs, ECGs, and dose interruptions;The percentage of patients with breast conservative surgery following neoadjuvant therapy;The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module) ;Progression-free survival (PFS) for the subgroup of patients with residual disease at surgery and receive adjuvant T-DM1 | — |
Countries
Nigeria
Contacts
Public ContactChibuzor Nkwodimma
Study Cordinator University College Hospital Ibadan
Outcome results
None listed