drugset
drugset / Trial / NCT00310180

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

NCT00310180 ↗

Phase 3 Active not recruiting 10273 enrolled National Cancer Institute (NCI) American College of Surgeons · collabCancer and Leukemia Group B · collabNCIC Clinical Trials Group · collabNSABP Foundation Inc · collabNorth Central Cancer Treatment Group · collabSWOG Cancer Research Network · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-04-07
Primary completion
2018-03-02
Completion
2030-09-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Anastrozole Other / unclassified — Oral
Background Exemestane Small molecule — Oral
Background Letrozole Other / unclassified — Oral
Background Tamoxifen Small molecule — Oral

Indications

breast adenocarcinoma hormone receptor-positive breast cancer