A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.
PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a partially blinded, partially randomized, multicenter study. Patients are assigned to 1 of 3 groups based on circulating tumor cells (CTCs) after 1 course of chemotherapy.
All patients undergo blood collection before their first dose of first-line chemotherapy* to determine baseline CTC count. Patients with < 5 CTCs at baseline are assigned to group I. Patients with ≥ 5 CTCs at baseline undergo a second blood draw on day 22 (after completion of 1 course of chemotherapy). Patients with < 5 CTCs after completing 1 course of chemotherapy are assigned to group 2. Patients with ≥ 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3.
NOTE: *Chemotherapy may be initiated while waiting for the baseline CTC result.
Group 1 (low risk of early progression): Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.
Group 2 (moderate risk of early progression): Patients continue to receive their current chemotherapy regimen without change.
Group 3 (high risk of early progression): Patients are stratified according to HER-2 status (positive vs negative) and disease type (bone-only vs measurable disease). Patients are randomized to 1 of 2 treatment arms.
Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level.
In groups 2 and 3, blood is collected periodically during chemotherapy and then at the completion of chemotherapy. Samples are examined for CTCs via the CellSearchâ„¢ blood test. Blood is also tested for CA 15-3 and carcinoembryonic antigen (CEA).
After completion of study therapy, patients are followed for up to 5 years.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Meets 1 of the following criteria:
HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay
Planning to undergo first-line chemotherapy for metastatic disease
Patients with brain metastases must have stable disease for > 90 days after completion of prior radiotherapy to the brain
No leptomeningeal disease
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed
At least 1 year since prior adjuvant chemotherapy
At least 2 weeks since prior minor surgery and recovered
At least 4 weeks since prior major surgery and recovered
No prior chemotherapy for metastatic disease
Concurrent hormonal therapy and/or bisphosphonate therapy allowed
Concurrent trastuzumab and/or bevacizumab allowed
Loma Linda, California 92354, United States
Los Angeles, California 90089-9181, United States
Aurora, Colorado 80045, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
Orlando, Florida 32803-1273, United States
Valdosta, Georgia 31602, United States
Boise, Idaho 83706, United States
Indianapolis, Indiana 46256, United States
La Porte, Indiana 46350, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Lebanon, New Hampshire 03756-0002, United States
Albuquerque, New Mexico 87110, United States
East Syracuse, New York 13057, United States
The Bronx, New York 10461, United States
White Plains, New York 10601, United States
Portland, Oregon 97213-2967, United States
Reading, Pennsylvania 19612-6052, United States
Scranton, Pennsylvania 18508, United States
Jackson, Tennessee 38301, United States
San Antonio, Texas 78229-3900, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States
Green Bay, Wisconsin 54301-3526, United States
Manitowoc, Wisconsin 54221-1450, United States