|Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
This randomized phase III trial is trying to find out 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 or by stopping them from dividing. 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.
Further Study Information
I. 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 11-25).
II. To create a tissue and specimen bank for patients enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and DNA obtained from peripheral blood.
I. To determine whether adjuvant hormonal therapy is sufficient treatment (i.e. 10 year distant disease-free survival of at least 95%) for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the "Secondary Study Group-1" category (Oncotype DX Recurrence Score =< 10).
II. 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 results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests.
III. To estimate failure rates as a function of 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.
IV. RS gene groups (proliferation gene group, HER2 gene group, ER gene group, invasion gene group, and other genes).
I. 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).
II. 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).
III. 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).
IV. To determine whether age will be inversely associated with a fear of recurrence, independent of treatment assignment.
V. Among participants receiving hormonal treatment alone on arm A and arm B, to determine whether ODRS will be inversely correlated with fear of recurrence.
VI. 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.g., CTCs and plasma tumor DNA) and host factors (e.g., estrogen, insulin-IGF axis, inflammation, etc).
VII. To create a biorepository of metastatic tumor samples in patients who have had a late relapse.
VIII. To determine body mass index (BMI) and comorbidity burden in patients with operable breast cancer five or more years after diagnosis.
IX. To determine whether there is a relationship between late relapse and BMI at diagnosis and at 5 years after diagnosis, and whether BMI-associated inflammatory and/or metabolic biomarkers are associated with early and late recurrence.
OUTLINE: This is a multicenter, partially randomized study. Patients are assigned to 1 of 3 treatment groups based on their risk of distant recurrence determined by Oncotype DX Breast Cancer Assay.
GROUP 1 (SECONDARY STUDY GROUP 1; ONCOTYPE DX RECURRENCE SCORE [ODRS] < 11): Patients receive standard hormonal therapy (e.g., oral tamoxifen alone, oral aromatase inhibitor [e.g., anastrozole, letrozole, or exemestane] alone, or oral tamoxifen followed by oral aromatase inhibitor) at the discretion of the treating physician for 5 or 10 years.
GROUP 2 (PRIMARY STUDY GROUP; ODRS 11-25): Patients are stratified according to tumor size (≤ 2.0 cm vs ≥ 2.1 cm), menopausal status (postmenopausal vs premenopausal vs perimenopausal), planned chemotherapy (taxane-containing [i.e., paclitaxel, docetaxel] vs nontaxane-containing), planned radiotherapy (whole breast with no boost planned vs whole breast with boost planned vs partial breast irradiation planned vs no planned radiation therapy [for patients who have had a mastectomy]) and Oncotype DX Recurrence Score (11-15 vs 16-20 vs 21-25). Patients are then randomized to receive either hormonal therapy alone or combination chemotherapy and hormonal therapy.
ARM I (EXPERIMENTAL): Patients receive hormonal therapy as in group 1 at the discretion of the treating physician.
ARM II (STANDARD): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in group 1 at the discretion of the treating physician.
GROUP 3 (SECONDARY STUDY GROUP 2; ODRS > 25): Patients receive combination chemotherapy as in group 2, arm II followed by hormonal therapy as in group 1.
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. Patients participating in NSABP and/or RTOG partial irradiation trial(s) may receive partial breast radiation.
Tissue obtained at surgery (performed prior to study entry) is examined by the Oncotype DX Recurrence Score Assay and other assays to correlate response with various biomarkers. Patients may complete quality-of-life assessments at baseline and at 3, 6, 12, 24, and 36 months.
After completion of study treatment, patients are followed up periodically for up to 20 years.
Trial Lead Organizations/Sponsors
National Cancer InstituteSouthwest Oncology Group
American College of Surgeons
North Central Cancer Treatment Group
Cancer and Leukemia Group B
National Surgical Adjuvant Breast and Bowel Project
NCIC-Clinical Trials Group
Link to the current ClinicalTrials.gov record.
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.