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Breast

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Unique Dataset IDnci-data-87ClinicalTrial.gov IDNCT00310180
DownloadableNo
SponsorNational Cancer Institute (NCI)Data ProviderNational Cancer InstituteTotal Study Enrolled Patients10273RandomizationYesPubMed (PMID)29860917.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, RadiationDataset TypeOther

NCI Description

This dataset contains the analysis data published in PMID 29860917 from trial TAILORx (NCT00310180).

Clinical Trial Title

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category (Oncotype DX Recurrence Score 11-25). II. To create a tissue and specimen bank for patients enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and deoxyribonucleic acid (DNA) obtained from peripheral blood. SECONDARY OBJECTIVES: I. To determine whether adjuvant hormonal therapy is sufficient treatment (i.e. 10 year distant disease-free survival of at least 95%) for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the "Secondary Study Group-1" category (Oncotype DX Recurrence Score less than 10). II. To compare the outcomes projected at 10 years by Adjuvant (with outcomes projected using classical pathologic information including tumor size, hormone receptor status, and histologic grade) with those made by the Genomic Health Oncotype DX test. Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests. III. To estimate failure rates as a function of recurrence score (RS) separately in the chemotherapy (arms C, D) and no chemotherapy (arms A, B) groups. The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect, if any, at the upper range of the RS 11 - 25 group. IV. To determine the prognostic significance of the Oncotype DX recurrence score and of the individual RS gene groups (proliferation gene group, human epidermal growth factor receptor [HER]2 gene group, estrogen receptor [ER] gene group, invasion gene group, and other genes).

Outcome Measures

Primary: 5-year Disease-free Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ] Secondary: 5-year Distant Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years ] 5-year Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years ] 5-year Overall Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years ] 5-year Disease-free Survival by Age and Recurrence Score Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ] To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test [ Time Frame: Assessed at 10 years after study entry ] 5-year Disease-free Survival by Individual RS Gene Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00310180-D1-Data-Dictionary.pdf

DATA: NCT00310180-D1-Dataset.csv

OTHER: README.pdf