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Neoadjuvant Herceptin in Patients With Breast Cancer

This study has been terminated.
(Closed to accrual 4/19/2006 / Study doesn't qualify for reporting.)
Genentech, Inc.
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center Identifier:
First received: August 22, 2005
Last updated: February 3, 2017
Last verified: February 2017
The purposes of this study are to better understand how Herceptin causes tumors to become smaller and to find out how effective Herceptin, together with chemotherapy, is in treating advanced breast cancer.

Condition Intervention Phase
Drug: Herceptin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer

Resource links provided by NLM:

Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer [ Time Frame: 1 year ]
    A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin

Secondary Outcome Measures:
  • To determine clinical response to therapy with Herceptin and Taxotere [ Time Frame: one year ]

Enrollment: 40
Study Start Date: October 2001
Study Completion Date: April 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heceptin
Herceptin administered to enrolled subjects
Drug: Herceptin
Other Name: Trastuzumab

Detailed Description:

We want to determine the effects of Herceptin and to determine its efficacy in women with HER-2 overexpressing advanced breast cancer. The end-points will include the comparison of an array of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin.

The other aim of this study would be to determine clinical response to therapy with Herceptin and Taxotere.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must be female.
  • Informed consent must be signed.
  • Women with locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size > 4 cm, and/or are deemed surgically inoperable.
  • Her2/neu overexpressing tumors defined as HercepTest score of 3+, or >/= one-third of invasive tumor showing membranous staining, or fluorescence in situ hybridization (FISH) positive.
  • Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
  • Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal.
  • Performance status (World Health Organization [WHO] scale) < 2 and life expectancy > 6 months.
  • Age > 18.
  • No metastatic disease without concomitant primary breast cancer.
  • No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

  • Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
  • Severe underlying chronic illness or disease.
  • Cardiomyopathy or baseline left ventricular ejection fraction (LVEF) < 50%.
  • Patients on other investigational drugs while on study.
  • Severe or uncontrolled hypertension defined as blood pressure (BP) > 180/100 on three separate occasions.
  • History of congestive heart failure.
  • History of coronary arterial disease.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00133796

United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mothaffar Rimawi
Genentech, Inc.
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center, Baylor College of Medicine
  More Information

Responsible Party: Mothaffar Rimawi, Medical Director, Baylor Breast Care Center Identifier: NCT00133796     History of Changes
Other Study ID Numbers: H-10379
Study First Received: August 22, 2005
Last Updated: February 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Baylor Breast Care Center:
Breast Cancer
Advanced Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on May 24, 2017