MDACC Study Summary ID99-146 (Archived)

Study Summary
No. ID99-146:.......Breast......Aman U. Buzdar......Breast Medical Oncology

Study Summary Title



Study Summary Number:	ID99-146

Study Title:	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

Physician

New Patient Referral



Name:	Aman U. Buzdar	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Breast Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2817 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Every 3 weeks

Treatment Agents:	Herceptin Taxol	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to see if the addition of Herceptin
to standard chemotherapy prior to surgery would shrink the tumor more. Another
goal will be to see whether adding Herceptin would be better at preventing
tumor recurrence (coming back). The safety of giving Herceptin with standard
chemotherapy will be studied. Another goal is to learn the effect of the
treatment on your heart function some months after the completion of your
therapy.

Study Objectives / Outcomes

To confirm the ability to downstage primary tumors overexpressing the Her2 receptor by the addition of Herceptin to standard chemotherapy in the neoadjuvant setting.

Determine the potential of the addition of Herceptin to increase the possibility of breast conservation.

Evaluate the impact of this regimen on both disease-free and overall survival for all patients treated.

Studying and comparing the safety and toxicity profiles with the addition of Herceptin to standard chemotherapy (treated in control in the earlier phase).

Evaluate the biologic significance of Her2 expression detected by immunohistochemistry
(IH) and Fluorescent in-situ hybridization (FISH).

Study Status Information



Study Activation / Registration Date:	04/09/2001

IRB Review and Approval Date:	07/07/1999

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) All patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast with T2-3 (greater than 2 cm), N0-1, M0 will be eligible. Patients with T1N1 (after histological confirmation of nodal disease) will be eligible for the study.

2) Histologic confirmation of invasive tumor will be done by core needle biopsy. On the tissue obtained, estrogen and progesterone receptors (ER/PR) as well as Her-2/neu (will be determined by IH and/or FISH) and p53 will be done (for research evaluation). Tumor proliferation rate will be evaluable by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67. Residual tumor tissue will be saved in the tissue bank for further future studies.

3) All patients who are Her-2/neu positive will be eligible for the study. Her-2/neu positivity for protocol purposes will be determined by IHC and patients with tumors that are 3+ or FISH + will be eligible.

4) Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.

5) All patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >1,500/mm3, and platelet count > 100,000 mm3. Patients must have adequate liver function, with a bilirubin within normal laboratory values. In addition, patients should have adequate renal function, defined as serum creatinine <2.0 mg%.

6) Patients must have a normal cardiac ejection fraction as determined by baseline echocardiogram. Tape must be saved for review by central cardiologist.

7) Patients who underwent biopsy outside will be eligible if they had a measurable residual tumor.

8) Patients with multicentric disease and extensive DCIS will be eligible for study.

9) Patients with a history of cardiac arrhythmia will be eligible for study after being cleared by cardiology.

Exclusion Criteria:

1) Patients with T1N0 disease are not eligible for the study.

2) Those patients with history of other invasive malignancies will be excluded except non-melanoma skin cancer and non-invasive cervical cancer.

3) Patients with a history of congestive heart failure will be excluded.

4) Patients who had surgical therapy prior to referral will be ineligible.

Links

Registration Number: NCT00038402
Study Information on Clinical Trials Registry (clinicaltrials.gov)