Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Genentech, Inc.
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136539
First received: August 26, 2005
Last updated: February 15, 2013
Last verified: February 2013

August 26, 2005
February 15, 2013
March 1999
November 2006   (final data collection date for primary outcome measure)
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 ]
To determine the response of HER2-positive breast cancer to treatment with Herceptin and taxol prior to surgery.
Complete list of historical versions of study NCT00136539 on ClinicalTrials.gov Archive Site
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To examine the safety of Herceptin and taxol therapy followed by surgery and chemotherapy.
Not Provided
Not Provided
 
Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer
Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Herceptin
    Given intravenously once weekly for 12 weeks prior to surgery.
  • Drug: Taxol
    Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
  • Drug: Adriamycin
    Given every three weeks for 12 weeks after surgery.
  • Drug: Cytoxan
    Given every three weeks for 12 weeks after surgery.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
March 2012
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00136539
98-222
Not Provided
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
Harold J. Burstein, MD, PhD
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Bristol-Myers Squibb
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Harvard Vanguard Medical Associates
  • Brigham and Women's Hospital
Principal Investigator: Harold Burstein, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
February 2013

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