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

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

March 22, 2013

Start Date ^ICMJE

October 2001

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00133796 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Neoadjuvant Herceptin in Patients With Breast Cancer

Official Title ^ICMJE

A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

BREAST CANCER

Intervention ^ICMJE

Drug: Herceptin

Other Name: Herceptin, Trastuzumab

Study Arm (s)

Active Comparator: One

Herceptin

Intervention: Drug: Herceptin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00133796

Other Study ID Numbers ^ICMJE

H-10379

Has Data Monitoring Committee

Yes

Responsible Party

Baylor Breast Care Center

Study Sponsor ^ICMJE

Baylor Breast Care Center

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Principal Investigator:

Mothaffar Rimawi, MD

Baylor Breast Center, Baylor College of Medicine

Information Provided By

Baylor Breast Care Center

Verification Date

March 2013

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

To Top