Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

August 26, 2005

Last Updated Date

August 24, 2009

Start Date ^ICMJE

March 1999

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine the response of HER2-positive breast cancer to treatment with Herceptin and taxol prior to surgery.

Change History

Complete list of historical versions of study NCT00136539 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To examine the safety of Herceptin and taxol therapy followed by surgery and chemotherapy.

Descriptive Information

Brief Title ^ICMJE

Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

Official Title ^ICMJE

Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Herceptin
Drug: Taxol
Drug: Adriamycin
Drug: Cytoxan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

November 2009

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00136539

Responsible Party

Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute

Study ID Numbers ^ICMJE

98-222

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Genentech
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Harvard Vanguard Medical Associates
Faulkner Hospital

Investigators ^ICMJE

Principal Investigator:

Harold Burstein, MD, PhD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP