Enrollment complete
(PROTOCOL PACCT-1) PROGRAM FOR THE ASSESSMENT OF CLINICAL CANCER TESTS (PACCT-1): TRIAL ASSIGNING INDIVIDUALIZED OPTIONS FOR TREATMENT: THE TAILORX TRIAL
NCT No.: NCT00310180
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: Colorado
Acronym:
Official Title
(PROTOCOL PACCT-1) PROGRAM FOR THE ASSESSMENT OF CLINICAL CANCER TESTS (PACCT-1): TRIAL ASSIGNING INDIVIDUALIZED OPTIONS FOR TREATMENT: THE TAILORX TRIAL
Purpose
This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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The patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy;
A tissue specimen from the primary breast cancer has been located and is ready to be shipped to the appropriate laboratory after consent is obtained and within 3 days following pre-registration; NOTE: For determination of the Oncotype Recurrence Score, tissue must be shipped to Genomic Health; if the Oncotype DX Recurrence Score was previously performed by Genomic Health (prior to pre-registration), tissue must be submitted to the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility upon randomization;
Leukocyte count >= 3500/mm^3;
Platelets >= 100,000/mm^3;
Serum creatinine =< 1.5 mg/dL
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Exclusion Criteria
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Criteria re: other prior treatments:
No prior chemotherapy for this malignancy
No prior radiation therapy for this malignancy; this includes no prior MammoSite Brachytherapy radiation therapy (RT);
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to pre-registration to rule out pregnancy
Women of childbearing potential must be strongly advised to utilize an accepted and effective form of non-hormonal contraception (e.g. intrauterine device, condoms, diaphragm, abstinence);
Patients must not have previously had the Oncotype DX Assay performed, with the exception of patients who have had the assay performed and have a recurrence score of 11-25
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Keywords and/or Specific Medical Conditions
- Obstetrics and Gynecology
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Sponsors
- National Cancer Institute (NCI)
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