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Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Study acronym: TAILORx
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 1657 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Study sites revised (1222)
  2. Minor Re-verified, no change to tracked fieldsv1656
  3. Minor Study sites revised (1222)v1655 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (1222)v1654 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites revised (1222)v1653 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Study sites revised (1222)v1652 See this version in full on ClinicalTrials.gov ↗
  2. Minor Study sites revised (1222)v1651 See this version in full on ClinicalTrials.gov ↗
  3. Minor Study sites revised (1222)v1650 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study sites revised (1222)v1649 See this version in full on ClinicalTrials.gov ↗
  5. Minor Study sites revised (1222)v1648 See this version in full on ClinicalTrials.gov ↗
  6. Minor Study sites: 1223 to 1222v1647
  7. Minor Re-verified, no change to tracked fieldsv1646
  8. Minor Study sites revised (1223)v1645 See this version in full on ClinicalTrials.gov ↗
  9. Minor Study sites: 1224 to 1223v1644
  10. Minor Study sites revised (1224)v1643 See this version in full on ClinicalTrials.gov ↗
  11. Minor Study sites: 1225 to 1224v1642
  12. Minor 22 versions Re-verified since Mar 11, 2026, no change to tracked fieldsv1620-v1641
  13. Minor Study sites revised (1225)v1619 See this version in full on ClinicalTrials.gov ↗
  14. Minor 4 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv1615-v1618
  15. Minor Study sites revised (1225)v1614 See this version in full on ClinicalTrials.gov ↗
  16. Minor Study sites revised (1225)v1613 See this version in full on ClinicalTrials.gov ↗
  17. Minor Re-verified, no change to tracked fieldsv1612
  18. Minor Study sites revised (1225)v1611 See this version in full on ClinicalTrials.gov ↗
  19. Minor Study sites: 1226 to 1225v1610
  20. Minor Study sites revised (1226)v1609 See this version in full on ClinicalTrials.gov ↗
  21. Minor Re-verified, no change to tracked fieldsv1608
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00310180
Lead Sponsor National Cancer Institute (NCI)
Collaborators: American College of Surgeons, Cancer and Leukemia Group B, NSABP Foundation Inc, NCIC Clinical Trials Group, North Central Cancer Treatment Group, SWOG Cancer Research Network
Conditions Breast Adenocarcinoma, Hormone Receptor Positive, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIB Breast Cancer AJCC v7
Enrollment 10,273 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov