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.)
Information provided by (Responsible Party):
Baylor Breast Care Center
First received: August 22, 2005
Last updated: March 22, 2013
Last verified: March 2013
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.
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of the Effects of Herceptin in Patients With Locally Advanced HER-2/NEU Overexpressing Breast Cancer
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- To determine clinical response to therapy with Herceptin and Taxotere [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2005 (Final data collection date for primary outcome measure)
Active Comparator: One
Other Name: Herceptin, Trastuzumab
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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133796
|Baylor Breast Center
|Houston, Texas, United States, 77030 |
Baylor Breast Care Center
||Mothaffar Rimawi, MD
||Baylor Breast Center, Baylor College of Medicine
No publications provided
||Baylor Breast Care Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 22, 2005
||March 22, 2013
||United States: Food and Drug Administration
Keywords provided by Baylor Breast Care Center:
Advanced Breast Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Neoplasms by Site