Clinical trial NCT00133796: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: BREAST CANCER
Keywords: Breast Cancer
Advanced Breast Cancer
Lead sponsor: Baylor Breast Care Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-08-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The effects of Herceptin and its efficacy in women with HER-2 overexpressing advanced breast cancer
timeFrame: 1 year
Secondary outcomes:
measure: To determine clinical response to therapy with Herceptin and Taxotere
timeFrame: one year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor Breast Center
state: Texas
Study officials:
affiliation: Baylor Breast Center, Baylor College of Medicine
name: Mothaffar Rimawi, MD
role: PRINCIPAL_INVESTIGATOR
References: