Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Genentech Bristol-Myers Squibb Massachusetts General Hospital Beth Israel Deaconess Medical Center Harvard Vanguard Medical Associates Faulkner Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00136539

Purpose

The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.

Condition	Intervention	Phase
Breast Cancer	Drug: Herceptin Drug: Taxol Drug: Adriamycin Drug: Cytoxan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet Trastuzumab

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment:	41
Study Start Date:	March 1999
Estimated Study Completion Date:	November 2009
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Given intravenously once weekly for 12 weeks prior to surgery.

Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.

Given every three weeks for 12 weeks after surgery.

Detailed Description:

Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10).

After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy).

Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total).

After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram.

At the time of surgery, re-assessment of the tumor will be done.

Blood work will be performed on day one of each chemotherapy cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have Stage II or III histologically diagnosed breast cancer
Primary invasive breast cancers that overexpress the HER2/neu oncogene
Age older than 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of < 1
White blood cell (WBC) > 4000/mm3
Platelet count > 100,000/mm3
Bilirubin < 1 x upper limit of normal (ULN)
SGOT < 1 x ULN
Creatinine < 1.5mg/dl
Normal cardiac function and electrocardiogram (EKG) showing absence of ischemic changes or ventricular hypertrophy

Exclusion Criteria:

Excisional biopsy, sentinel node dissection or axillary node dissection.
Prior history of breast cancer unless: diagnosed at least 2 years ago, present cancer is not in a previously irradiated breast, no prior therapy with anthracycline or taxane, no prior high-dose chemotherapy with stem cell or bone marrow transplant.
Pregnant or breast-feeding women
Uncontrolled infection
Active or severe cardiovascular or pulmonary disease
Peripheral neuropathy of any etiology that exceeds grade 1
Prior history of malignancy treated without curative intent
Uncontrolled diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136539

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Genentech

Bristol-Myers Squibb

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Harvard Vanguard Medical Associates

Faulkner Hospital

Investigators

Principal Investigator:

Harold Burstein, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Harold J. Burstein, MD, PhD )
Study ID Numbers:	98-222
Study First Received:	August 26, 2005
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00136539 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Breast Cancer
Early Stage Breast Cancer
HER2-positive
HER2-positive breast cancer

Herceptin
Taxol
Stage II Breast Cancer
Stage III Breast Cancer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Antimitotic Agents
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009