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

August 22, 2005
March 22, 2013
October 2001
September 2005   (final data collection date for primary outcome measure)
  • 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 ]
The effects of Herceptin and its efficacy in women w/ HER-2 overexpressing advanced breast cancer. A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin.
Complete list of historical versions of study NCT00133796 on ClinicalTrials.gov Archive Site
To determine clinical response to therapy with Herceptin and Taxotere [ Time Frame: one year ] [ Designated as safety issue: Yes ]
The other aim of this study would be to determine clinical response to therapy with Herceptin and Taxotere.
Not Provided
Not Provided
 
Neoadjuvant Herceptin in Patients With Breast Cancer
A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
BREAST CANCER
Drug: Herceptin
IV
Other Name: Herceptin, Trastuzumab
Active Comparator: One
Herceptin
Intervention: Drug: Herceptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
April 2007
September 2005   (final data collection date for primary outcome measure)

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.
Female
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00133796
H-10379
Yes
Baylor Breast Care Center
Baylor Breast Care Center
Genentech
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center, Baylor College of Medicine
Baylor Breast Care Center
March 2013

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