Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
2018-03-02
NCT00310180Uploaded 04-24-2019
Access via NCI by Request
PDS UID: nci-data-393
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
Provider Information
Provider Data DescriptionThis dataset contains the analysis data published in PMID 29860917 from trial TAILORx (NCT00310180).
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsBreast 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
Intervention TypeDrug: Anastrozole
Drug: Exemestane
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen Citrate
Drug(s)Drug: Anastrozole
Drug: Exemestane
Drug: Letrozole
Drug: Tamoxifen Citrate
Total Enrolled10273
RandomizationRandomized
Blinding MethodNone
Arms InterventionGroup 1 (Oncotype DX recurrence score =< 10) - Experimental
Group 2, Arm I (experimental) - Experimental
Group 2, Arm II (standard) - Active Comparator
Group 3 (Oncotype DX recurrence score >= 26) - Experimental
Secondary IDNCI-2009-00707
PubMed (PMID)35175284
34137783
34090143
33626896
32271671
31566680
31409130
31157962
29860917
26412349
Collaborator(s)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
Region(s)United States
Australia
Canada
Ireland
New Zealand
Peru
Puerto Rico
United Kingdom
Age Range18 Years to 75 Years (ADULT, OLDER_ADULT)
Files: NCT00310180-D1
Data DictionaryNCT00310180-D1-Data-Dictionary.pdf
DATANCT00310180-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00310180-D4
Data DictionaryNCT00310180-D4-Data-Dictionary.pdf
DATANCT00310180-D4-Dataset.csv
OTHERREADME.pdf
Files: NCT00310180-D5
Data DictionaryNCT00310180-D5-Data-Dictionary.pdf
DATANCT00310180-D5-Dataset.csv
OTHERREADME.pdf
Files: NCT00310180-D6
Data DictionaryNCT00310180-D6-Data-Dictionary.pdf
DATANCT00310180-D6-Dataset.csv
OTHERREADME.pdf
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use