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Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

Phase 2
18 Years
Not Enrolling
Breast Neoplasm

Thank you

Trial Information

Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Lee S Schwartzberg, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Accelerated Community Oncology Research Network, Inc. (ACORN)


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

August 2011

Related Keywords:

  • Breast Neoplasm
  • neoadjuvant chemotherapy
  • HER2 positive breast cancer
  • stage II - III breast cancer
  • Breast Neoplasms
  • Neoplasms



Arena Oncology Associates Great Neck, New York  11021
Augusta Oncology Associates Augusta, Georgia  30901
The West Clinic Memphis, Tennessee  38120
Advanced Medical Specialties Miami, Florida  33176
Cental Georgia Cancer Care Macon, Georgia  31201
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Hematology Oncology Centers of the Northern Rockies, PC Billings, Montana  59101