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Neoadjuvant Herceptin in Patients With Breast Cancer

This study has been terminated.
(Study was closed to accrual as of 4/19/2006 / Study did not qualify for reporting.)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00133796
First received: August 22, 2005
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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
BREAST CANCER
 Drug: Herceptin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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

Estimated 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
Active Comparator: One
Herceptin
 Drug: Herceptin
IV
Other Name: Herceptin, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133796

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

No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00133796     History of Changes
Other Study ID Numbers: H-10379
Study First Received: August 22, 2005
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013