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

Accelerated Community Oncology Research Network

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasm

Treatments: Drug: cyclophosphamide; Drug: epirubicin; Drug: docetaxel; Drug: trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00270894

ACORN ALSSNBC0401

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Neoadjuvant therapy

Experimental group

Description:

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.

Treatment:

Drug: trastuzumab

Drug: docetaxel

Drug: epirubicin

Drug: cyclophosphamide