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Study record managers: refer to the Data Element Definitions if submitting registration or information. To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category Oncotype DX Recurrence Score To create a tissue and specimen bank for patients enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and deoxyribonucleic acid DNA obtained from peripheral blood.
To determine whether adjuvant hormonal therapy is sufficient treatment i. To compare the outcomes projected at 10 years by Adjuvant with outcomes projected using classical pathologic information including tumor size, hormone receptor status, and histologic grade with those made by the Genomic Health Oncotype DX test. Classical pathologic information and outcome will also be used to create and refine models that would use classical information instead of or in combination with genomic tests. To estimate failure rates as a function of recurrence score RS separately in the chemotherapy arms C, D and no chemotherapy arms A, B groups.
The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect, if any, at the upper range of the RS 11 - 25 group. To determine the prognostic ificance of the Oncotype DX recurrence score and of the individual RS gene groups proliferation gene group, human epidermal growth factor receptor [HER]2 gene group, estrogen receptor [ER] gene group, invasion gene group, and other genes.
To evaluate the effects of chemotherapy and hormonal therapy vs hormonal therapy alone on perceived cognitive impairment, fatigue, fear of recurrence among pre-menopausal patients, endocrine symptoms and sexual dysfunction, and overall health-related quality of life HRQL. To determine whether perceived cognitive impairment, fatigue, fear of recurrence, endocrine symptoms, and overall HRQL are similar for patients receiving chemotherapy plus hormonal therapy in secondary study group 2 as for those in the primary study group arm D vs C.
To determine whether perceived cognitive impairment, fatigue, fear of recurrence, endocrine symptoms, and overall HRQL are similar for patients receiving hormonal therapy alone in secondary study group 1 as for those in the primary study group arms A vs B.
To determine whether age will be inversely associated with a fear of recurrence, independent of treatment asment. Among participants receiving hormonal treatment alone on arm A and arm B, to determine whether Oncotype DX Recurrence score will be inversely correlated with fear of recurrence.
To create a biospecimen repository including plasma, serum and CellSearch cassettes containing circulating tumor cells CTC for evaluating determinants of late relapse, including candidate biomarkers reflecting occult tumor burden e. To create a biorepository of metastatic tumor samples in patients who have had a late relapse. To determine body mass index BMI and comorbidity burden in patients with operable breast cancer five or more years after diagnosis.
Patients are ased to 1 of 3 treatment groups.
Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Patients in all groups who have had breast-conservation surgery are also treated with radiotherapy. Radiotherapy should begin within 4 weeks of registration for patients receiving hormonal therapy alone or within 8 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up every months for 5 years and then annually for 15 years. Some patients then continue to receive hormone therapy for an additional 5 years. Secondary Outcome Measures : 5-year Distant Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years ] Distant recurrence-free interval DRFI is defined as time from date of randomization or registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death is the first manifestation of distant recurrence.
DFS is evaluated by recurrence score vs. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment and meet the following criteria:. Tumor size 1. Patients with the following medical conditions should not be enrolled on the study:.
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. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. First Posted : March 12, Last Update Posted : June 23, Study Description. 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 DXand whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 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. Show detailed description. Hide detailed description. Detailed Description:. MedlinePlus related topics: Breast Cancer Hormones.
FDA Resources. Arms and Interventions. Undergo radiation therapy or partial breast irradiation. Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Patients receive standard combination chemotherapy at the discretion of the treating physician. Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are ased to receive both types of treatment.
Outcome Measures. Primary Outcome Measures : 5-year Disease-free Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ] Disease-free survival DFS is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer excluding non-melanoma skin cancersor death without evidence of recurrence. Overall survival OS is defined as time from date of randomization or registration to date of death from any cause.
Disease-free survival DFS is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer excluding non-melanoma skin cancersor death without evidence of recurrence. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations.
Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. JAMA Oncol. J Clin Oncol. Epub Apr 9.
Noninferiority trials with nonadherence to the ased randomized treatment. Clin Trials. Epub Aug N Engl J Med. Epub Jun 3. Epub Sep National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Phase 3.
Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Actual Primary Completion Date :. Estimated Study Completion Date :.
Experimental: Group 2, Arm I experimental Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Active Comparator: Group 2, Arm II standard Patients receive standard combination chemotherapy at the discretion of the treating physician. Mission Hills, California, United States, Colorado Springs, Colorado, United States, Eastern Connecticut Hematology and Oncology Associates. Washington, District of Columbia, United States, Jacksonville, Florida, United States, Arlington Heights, Illinois, United States, Hinsdale Hematology Oncology Associates Incorporated.
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