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Home > "E" Clinical Trials Conditions > Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer  Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , Bristol-Myers Squibb,Genentech,Pharmacia and Upjohn
Synopsis: The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other pojectives: 1)to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, 4) evaluate significance of HER2 expression by two different methods, and 5) determine correlation of cardiac blood tests with echocardiogram results in the detection of cardiac muscle damage.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Histological confirmation of invasive, but non-inflammatory T2-3 (greater than 2 cm), N0-1, M0 carcinoma of the breast. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible. Patients with T1N0 disease are not eligible. - Her-2/neu positivity of 3+ per IHC and/or positive per FISH. - Signed informed consent. - Negative history of other invasive malignancies other than non-melanoma skin cancer and non-invasive cervical cancer. - Adequate bone marrow function: granulocytes > 1,500/mm3 and platelets >100,000/mm3. Adequate liver and renal function: normal bilirubin and creatinine < 2.0 mg%. - Normal cardiac ejection fraction per echocardiogram. - Negative history for congestive heart failure. If history of cardiac arrhythmia, eligible after cleared by cardiology. - Must have measurable residual tumor post baseline biopsy. Patients with multicentric and/or extensive DCIS are eligible.
Total Enrollment: 164
Location and Contact Information:
The University of Texas MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Deborah Francis 713-792-2817
Additional Information:
Study ID Numbers: ID99-146;
Study Start Date: April 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038402
Other Breast Cancer Studies:
1. Phase II trial of oral study drug in patients with advanced metastatic breast cancer who have experienced failure of an anthracycline, a taxane, and capecitabine
2. A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
3. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
4. Biological Therapy in Treating Patients With Metastatic Cancer
5. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
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Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
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