Neoadjuvant Herceptin in Patients With Breast Cancer

NCT00133796 | Terminated Phase 2 DMC

• 1 other identifier: H-10379
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

BREAST CANCER

Keywords

Breast Cancer; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The effects of Herceptin and its efficacy in women with 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

  1 year

Secondary Outcomes (1)

• To determine clinical response to therapy with Herceptin and Taxotere

  one year

Study Arms (1)

Heceptin

EXPERIMENTAL

Herceptin administered to enrolled subjects

Drug: Herceptin

Interventions

Herceptin DRUG

IV

Also known as: Trastuzumab

Heceptin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mothaffar Rimawi: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mothaffar Rimawi, MD

  Baylor Breast Center, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: October 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: April 1, 2007
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)