Status:
COMPLETED
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Lead Sponsor:
Accelerated Community Oncology Research Network
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients: * trastuzuma...
Detailed Description
This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period...
Eligibility Criteria
Inclusion
- Non-pregnant females =/\> 18 years of age
- Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
- Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
- Normal cardiac function and adequate hematologic function
- Human epidermal growth factor receptor 2 protein (HER2) positive
- No evidence of metastatic disease
- ECOG Performance Status 0 - 1
- Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
Exclusion
- Treated with other investigational drugs within 30 days
- Uncontrolled intercurrent disease or active infection
- Known sensitivity to e. coli-derived proteins or polysorbate 80
- Psychiatric illness or social situation that would limit study compliance
- Pre-existing peripheral neuropathy \> Grade 1
- Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
- Bilateral synchronous breast cancer
- Inflammatory breast cancer
- Women who are pregnant or breast feeding
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00270894
Start Date
November 1 2005
End Date
August 1 2011
Last Update
March 20 2012
Active Locations (7)
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1
Advanced Medical Specialties
Miami, Florida, United States, 33176
2
Augusta Oncology Associates
Augusta, Georgia, United States, 30901
3
Cental Georgia Cancer Care
Macon, Georgia, United States, 31201
4
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060