At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adenocarcinoma of the breast, completely resected
- ✓Estrogen and/or progesterone receptor positive
- ✓Negative axillary lymph nodes
- ✓HER2/neu negative by FISH or IHC (0 or 1+)
- ✕Prior invasive malignancy within 5 years (except skin cancer or cervical CIS)
- ✕Previous ipsilateral or contralateral invasive breast cancer, or bilateral synchronous cancers
- ✕Previous ipsilateral or contralateral DCIS
- ✕Prior chemotherapy for this malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
In Brief
A Phase 3 clinical trial evaluating Anastrozole, Exemestane, and 5 other interventions for Breast Adenocarcinoma and 6 related conditions. Active but no longer recruiting, targeting 10,273 participants across 1,222 sites in 8 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years.
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. 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 this group receive combination chemotherapy followed by hormone therapy similar to the patients in group two who are assigned to receive both types of treatment.
Interventions
Given PO
Given PO
Correlative studies
Given PO
Ancillary studies
Undergo radiation therapy or partial breast irradiation
Given PO