Hormone Therapy + Chemotherapy for Breast Cancer
(TAILORx Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Joseph A Sparano
Principal Investigator
ECOG-ACRIN Cancer Research Group
Eligibility Criteria
This trial is for women with node-negative, estrogen-receptor positive breast cancer who have had surgery. They should expect to live at least 10 years and not have received prior radiation or chemotherapy for this cancer. Participants must not be pregnant, breastfeeding, or have serious health issues like heart failure or chronic liver disease.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Anastrozole (Hormone Therapy)
- Combination Chemotherapy (Chemotherapy)
- Exemestane (Hormone Therapy)
- Letrozole (Hormone Therapy)
- Tamoxifen Citrate (Hormone Therapy)
Anastrozole is already approved in Canada, Japan for the following indications:
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School
Cancer and Leukemia Group B
Collaborator
Dr. Richard L. Schilsky
Cancer and Leukemia Group B
Chief Executive Officer since 2012
MD from University of Chicago
Dr. Walter Stadler
Cancer and Leukemia Group B
Chief Medical Officer since 2012
MD from Harvard Medical School
SWOG Cancer Research Network
Collaborator
Dr. Charles D. Blanke
SWOG Cancer Research Network
Chief Executive Officer since 2012
MD from Oregon Health & Science University
Dr. Dawn Hershman
SWOG Cancer Research Network
Chief Medical Officer since 2020
MD from Columbia University
Southwest Oncology Group
Collaborator
Dr. Lyudmila Bazhenova
Southwest Oncology Group
Chief Medical Officer since 2021
MD from University of California, San Diego
Dr. Richard Schilsky
Southwest Oncology Group
Chief Executive Officer since 2013
MD from University of California, San Diego
NSABP Foundation Inc
Collaborator
Priya Rastogi
NSABP Foundation Inc
Chief Executive Officer since 2022
MD from University of Pittsburgh
Charles E. Geyer Jr.
NSABP Foundation Inc
Chief Medical Officer since 2022
MD from Texas Tech University
American College of Surgeons
Collaborator
North Central Cancer Treatment Group
Collaborator
NCIC Clinical Trials Group
Collaborator
Dr. Lesley Seymour
NCIC Clinical Trials Group
Chief Medical Officer since 2014
MD from University of Toronto
Dr. Janet Dancey
NCIC Clinical Trials Group
Chief Executive Officer since 2014
MD from Queen's University