Clinical trial NCT00270894: Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Official title: Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: neoadjuvant chemotherapy
HER2 positive breast cancer
stage II - III breast cancer
Lead sponsor: Accelerated Community Oncology Research Network
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-12-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule
timeFrame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)
measure: Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities
timeFrame: 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:
measure: Pathologic Response
timeFrame: At completion of neoadjuvant treatment period, up to 24 weeks.
measure: Clinical Response Prior to Surgery
timeFrame: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36
measure: Progression-free Survival (PFS)
timeFrame: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.
measure: Overall Survival (OS)
timeFrame: Measured from day 1 of treatment until time of death, assessed up to 48 months.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates
state: Georgia
city: Macon
country: United States
facility: Cental Georgia Cancer Care
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies, PC
state: Montana
city: Great Neck
country: United States
facility: Arena Oncology Associates
state: New York
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
Study officials:
affiliation: Accelerated Community Oncology Research Network, Inc. (ACORN)
name: Lee S Schwartzberg, MD, FACP
role: STUDY_CHAIR
References: