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Neoadjuvant Therapy With Herceptin and Taxol for Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Genentech
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
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Therapy With Herceptin and Taxol for Stage II/III Breast Cancer

Resource links provided by NLM:

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
Study Completion Date: March 2012
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Harold J. Burstein, MD, PhD
Dana-Farber Cancer Institute
Genentech
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Harvard Vanguard Medical Associates
Brigham and Women's Hospital
Investigators
Principal Investigator: Harold Burstein, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Harold J. Burstein, MD, PhD, Associate Professor of Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00136539     History of Changes
Other Study ID Numbers: 98-222
Study First Received: August 26, 2005
Last Updated: February 15, 2013
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013