Expired Study
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Houston, Texas 77030


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

H-10379


NCT ID:

NCT00133796


Secondary ID:


Study Acronym:


Brief Title:

Neoadjuvant Herceptin in Patients With Breast Cancer


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor Breast Care Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Study was closed to accrual as of 4/19/2006


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Mothaffar Rimawi, MD
Principal Investigator
Baylor Breast Center, Baylor College of Medicine

Study Dates

Start Date:October 2001
Completion Date:April 2007
Completion Type:Actual
Primary Completion Date:September 2005
Primary Completion Type:Actual
Verification Date:March 2013
Last Changed Date:March 22, 2013
First Received Date:August 22, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine clinical response to therapy with Herceptin and Taxotere
Time Frame:one year
Safety Issues:True
Outcome Type:Primary Outcome
Measure:A comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Herceptin
Time Frame:one year
Safety Issues:True
Outcome Type:Primary Outcome
Measure:The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer
Time Frame:1 year
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Herceptin
Description:IV
Arm Name:One
Other Name:Herceptin, Trastuzumab

Study Arms

Study Arm Type:Active Comparator
Arm Name:One
Description:Herceptin

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor Breast Care Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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