MDACC Study Summary 2003-0999

Study Summary
No. 2003-0999:.......Breast......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2003-0999

Study Title:	Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones

Physician

New Patient Referral



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

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8754 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients may receive chemotherapy or hormonal therapy in their referring hospitals. Patients will be seen 3, 6, 9, and 12 months point.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A. Treatment will take place in an outpatient clinic .


Description/ Intervention:	The goal of this study is to compare different imaging techniques in measuring the response of bone disease to treatment. Another goal is to compare different evaluation techniques (evaluation criteria) in reading the images. The change in the response of blood serum markers and the reliability of biochemical markers will also be studied

Study Objectives / Outcomes

PRIMARY OBJECTIVES:

1. To estimate and compare the sensitivity and specificity of computed tomography (CT), plain radiography

(XR), and skeletal scintigraphy (SS) with each other for the assessment of response of bone metastasis in patients with breast cancer.

2. To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients for the assessment of the behavior of osseous metastasis in breast cancer patients.

SECONDARY OBJECTIVES:
To evaluate the progression free survival (PFS) and overall survival (OS) of each response group (CR, PR, SD, PD) assessed by imaging and response criteria.

Study Status Information



Study Activation / Registration Date:	09/03/2004

IRB Review and Approval Date:	05/05/2004

Study Type:	Cancer Control

Recruitment Status:	Closed

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) Newly diagnosed bone (from calvarium to pelvis include ribs and sternum) and nonosseous (it should be measurable by CT) metastasis or primary breast tumor (with a confirmation of no surgical treatment for 12 months) from breast cancer. If the bone metastasis is not confirmed by imaging, bone biopsy is needed. Please see diagnostic flow sheet. (APPENDIX B)

2) Zubrod performance status 2 or less. (APPENDIX A)

3) Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.)

4) Patients must sign an informed consent document indicating awareness that this study is not focusing on the verification of treatment agents but on verification of modalities to assess bone tumor response, in keeping with institutional policy.

Exclusion Criteria:

1) Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer.

2) Patients who have the history of radiation therapy for bone disease.

3) History or presence of brain/leptomeningeal metastasis.

4) History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ

Links

Registration Number: NCT00420433
Study Information on Clinical Trials Registry (clinicaltrials.gov)