Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
18 Years
N/A
Female
Breast Neoplasm
Trial Information
Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
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 (weeks 20 to 24), and a post-surgical/follow-up period
(approximately 3 years). Subjects will be treated on an outpatient basis.
Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for
four cycles followed by a three week break. Subjects will then receive docetaxel every two
weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks
for 4 treatments.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
Outcome Description:
Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.
Outcome Time Frame:
From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
Safety Issue:
No
Principal Investigator
Lee S Schwartzberg, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Accelerated Community Oncology Research Network, Inc. (ACORN)
Authority:
United States: Food and Drug Administration
Study ID:
ACORN ALSSNBC0401
NCT ID:
NCT00270894
Start Date:
November 2005
Completion Date:
August 2011
Related Keywords:
- Breast Neoplasm
- neoadjuvant chemotherapy
- HER2 positive breast cancer
- stage II - III breast cancer
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Arena Oncology Associates | Great Neck, New York 11021 |
| Augusta Oncology Associates | Augusta, Georgia 30901 |
| The West Clinic | Memphis, Tennessee 38120 |
| Advanced Medical Specialties | Miami, Florida 33176 |
| Cental Georgia Cancer Care | Macon, Georgia 31201 |
| Northwest Georgia Oncology Centers, PC | Marietta, Georgia 30060 |
| Hematology Oncology Centers of the Northern Rockies, PC | Billings, Montana 59101 |
