Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

NCT ID: NCT00270894

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-08-31

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:

• trastuzumab (Herceptin)
• epirubicin (Ellence)
• cyclophosphamide (Cytoxan)
• docetaxel (Taxotere)

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 (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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant therapy

Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.

Group Type: EXPERIMENTAL

epirubicin

Intervention Type: DRUG

epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles

cyclophosphamide

Intervention Type: DRUG

cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles

docetaxel

Intervention Type: DRUG

docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles

trastuzumab

Intervention Type: DRUG

trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments

Interventions

epirubicin

epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles

Intervention Type: DRUG

cyclophosphamide

cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles

Intervention Type: DRUG

docetaxel

docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles

Intervention Type: DRUG

trastuzumab

trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments

Intervention Type: DRUG

Other Intervention Names

Ellence®; Cytoxan; Taxotere®; Herceptin®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Accelerated Community Oncology Research Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee S Schwartzberg, MD, FACP

Role: STUDY_CHAIR

Accelerated Community Oncology Research Network, Inc. (ACORN)

Locations

Advanced Medical Specialties

Miami, Florida, United States

Augusta Oncology Associates

Augusta, Georgia, United States

Cental Georgia Cancer Care

Macon, Georgia, United States

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States

Hematology Oncology Centers of the Northern Rockies, PC

Billings, Montana, United States

Arena Oncology Associates

Great Neck, New York, United States

The West Clinic

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

ACORN ALSSNBC0401

Identifier Type: -

Identifier Source: org_study_id