MDACC Study Summary ID01-580 (Archived)

Study Summary
No. ID01-580:.......Breast......Aman U. Buzdar......Breast Medical Oncology

Study Summary Title



Study Summary Number:	ID01-580

Study Title:	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients with 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:	- docetax & capecit & all other chemo at MDACC - q 3 wks + 3 days - pac or FEC under care of local doc - FU q 6 wks + 1 wk - after complete chemo & local ther, return q 4 mos for 1st 2 yrs + 2 mos, q 6 mos + 2 mos for next 2 yrs, then yrly + 2-3 mos

Treatment Agents:	Capecitabine Docetaxel Paclitaxel	Home Care:	Doses 2-12 of weekly paclitaxel and all doses of FEC may be administered under the care of the patient's local physician. Patients will be required to return to MDACC every 6 weeks while receiving chemotherapy administered by their local physician.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to compare paclitaxel to the
combination docetaxel and capecitabine in the treatment of breast cancer to see
which treatment is better for preventing recurrence (return of the cancer).
Another important goal is to determine which treatment is more effective at
eradicating tumor in the breast and lymph nodes. This will be studied in
patients who have not had surgery prior to starting chemotherapy. The safety of
the two different treatments will also be studied.

Study Objectives / Outcomes

· Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer
· Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel
· Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details)

Study Status Information



Study Activation / Registration Date:	11/08/2002

IRB Review and Approval Date:	04/03/2002

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) Patients with histologic confirmation of invasive, but non-inflammatory carcinoma of the breast.

2) Stage I (T1N0) are not eligible for the neo-adjuvant portion of the protocol.

3) High-risk patients (patients with any of the following: high proliferation rate - Ki67 >35% or poorly differentiated tumors (black's modified grade 3); ER/PR negative; lymphovascular invasion) with stage I disease are eligible for adjuvant therapy.

4) Patients with pure mucinous carcinomas, tubular carcinomas or pure medullary carcinomas are eligible if the patient's tumor is larger than 3 cm in size or if the patient has tumor involvement of the lymph nodes (>2mm).

5) Patients with bilateral breast cancers are eligible.

6) Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible as are patients with pN3a (ten or more axillary lymph nodes). Patients with infraclavicular lymph node involvement are NOT eligible.

7) Patients must have clinically measurable disease to be treated in the neoadjuvant setting. This includes patients with a non-palpable primary who have histologically proven LN involvement that is clinically palpable and measurable by ultrasound

8) Histologic confirmation of invasive tumor will be done by core needle biopsy for patients with intact primary tumors. If patients have undergone adequate core biopsy prior to evaluation at MDACC, repeat core biopsy is optional.

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

10) Patients with a prior history of breast cancer are eligible if the current primary breast cancer is of a higher stage than the original breast cancer and the patient has not received any of the current study medications including past doxorubicin.

11) 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 billirubin within normal laboratory values. Transaminases (SGPT) may be up to 2.5x upper limit of normal (ULN) if alkaline phosphatase is < ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN.

12) In addition, patients should have adequate renal function, defined as a serum creatinine < 2.5 mg% and/or creatinine clearance greater than 51 ml/min as calculated by Cockroft and Gault Equation: Cockroft and Gault Equation: Creatinine clearance for males = {(140 - age [yrs])(body wt [kg])}/{(72) (serum creatinine [mg/dL])}. Creatinine clearance for females = 0.85 x male value

13) Patients who had surgical therapy prior to referral will be eligible for randomization to systemic chemotherapy administered in the adjuvant setting.

14) Patients who have overexpression of the her-2/neu oncogene are eligible for the study.

Exclusion Criteria:

1) Patients with N2 (clinical staging) or N3 (clinical staging) nodal disease, inflammatory breast cancer, or metastatic disease are not eligible. This includes patients with infraclavicular and/or supraclavicular lymph node involvement. Patients with pN2a (metastasis in four to nine axillary lymph nodes) are eligible.

2) Patients with pN2b (metastasis in clinically apparent internal mammary lymph nodes in the absence of axillary lymph node metastasis) are not eligible. Patients with T4 lesions in the neoadjuvant setting are not eligible. Patients with limited T4 lesions in the adjuvant setting (for example, focal extension into the skin with negative margins) are eligible.

3) Severe hypersensitivity reactions to agents formulated in either cremaphor or polysorbate 80 must be excluded. Patients with hypersensitivity reactions to any of the study medications must be excluded.

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

5) Patients with uncompensated congestive heart failure are not eligible. Patients with myocardial infarction within the past 12 months are ineligible.

6) Patients who are pregnant or lactating are not eligible. Women of childbearing potential must have a negative pregnancy test prior to initiation of chemotherapy. Women of childbearing potential who will not use a reliable and appropriate contraceptive method during the study are not eligible.

7) Patients who have had an organ allograft are ineligible.

8) Patients with serious concurrent infections are ineligible.

9) Sexually active male patients unwilling to practice contraception during the study are ineligible.

10) Patients with pre-existing peripheral neuropathy > grade 1.

Links

Registration Number: NCT00050167
Study Information on Clinical Trials Registry (clinicaltrials.gov)