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

Accelerated Community Oncology Research Network30 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Neoplasm

Interventions

epirubicinDRUG

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

cyclophosphamideDRUG

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

docetaxelDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule

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.

Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)

Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities

Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.

Time frame: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.

Secondary Outcomes

Pathologic Response

Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as \>= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as \< 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and \< 25% increase in sum of diameters.

Time frame: At completion of neoadjuvant treatment period, up to 24 weeks.

Clinical Response Prior to Surgery

Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as \>= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as \< 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and \< 25% increase in sum of diameters.

Data from ClinicalTrials.gov

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