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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00270894
• Date of registration: 28/12/2005
• Primary sponsor: Accelerated Community Oncology Research Network
• Public title: Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
• Scientific title: Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
• Date of first enrolment: November 2005
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00270894
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Lee S Schwartzberg, MD, FACP
• Affiliation: Accelerated Community Oncology Research Network, Inc. (ACORN)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasm

Intervention(s)

Drug: cyclophosphamide

Drug: docetaxel

Drug: epirubicin

Drug: trastuzumab

Primary Outcome(s)

Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities [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.]

Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule [Time Frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)]

Secondary Outcome(s)

Clinical Response Prior to Surgery [Time Frame: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.]

Left Ventricular Ejection Fraction (LVEF) [Time Frame: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36]

Overall Survival (OS) [Time Frame: Measured from day 1 of treatment until time of death, assessed up to 48 months.]

Pathologic Response [Time Frame: At completion of neoadjuvant treatment period, up to 24 weeks.]

Progression-free Survival (PFS) [Time Frame: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.]

Secondary ID(s)

ACORN ALSSNBC0401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Aventis Pharmaceuticals