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, National Cancer Institute (NCI); results first posted 2019-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial). Trials, record NCT00310180. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00310180
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
- NCT number
- NCT00310180
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 10,273 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- 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
- Interventions
- Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment, Radiation Therapy, Tamoxifen Citrate
- First posted
- 2006-04-03
- Last updated
- 2026-10-01
- Results first posted
- 2019-03-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year Disease-free Survival | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years | Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method, and compared between the two randomized arms (arm B vs. arm C) using stratified log rank test and stratified Cox proportional hazard model. |
| Secondary | 5-year Distant Recurrence-free Interval | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years | Distant recurrence-free interval (DRFI) is defined as time from date of randomization or registration to the date of distant recurrence of breast cancer, or of death with distant recurrence, if death is the first manifestation of distant recurrence. The distribution of DRFI (eg, 5-year DRFI rate) is estimated using Kaplan-Meier method. |
| Secondary | 5-year Recurrence-free Interval | Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years | Recurrence-free interval (RFS) is defined as time from date of randomization or registration to the date of first recurrence of breast cancer (ipsilateral breast tumor recurrence, local/regional recurrence, distant recurrence) or to the date of death with recurrence, if death is the first manifestation of recurrence. The distribution of RFS (eg, 5-year RFS rate) is estimated using Kaplan-Meier method. |
| Secondary | 5-year Overall Survival | Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years | Overall survival (OS) is defined as time from date of randomization or registration to date of death from any cause. The distribution of OS (eg, 5-year OS rate) is estimated using Kaplan-Meier method. |
| Secondary | 5-year Disease-free Survival by Age and Recurrence Score Groups | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years | Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. DFS is evaluated by recurrence score (0-10 vs. 11-15 vs. 16-20 vs. 21-25 vs. \>25) and age groups (\<=50 vs. 51-65 vs. 65-75). The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. |
| Secondary | To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test | Assessed at 10 years after study entry | Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately. |
| Secondary | 5-year Disease-free Survival by Individual RS Gene Groups | Assessed every 6 months within 5 years from registration and then annually up to 20 years | Disease-free survival (DFS) is defined to be time from randomization to first event, where the first event is any of ipsilateral breast tumor recurrence, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancers), or death without evidence of recurrence. The distribution of DFS (eg, 5-year DFS rate) is estimated using Kaplan-Meier method. 5-year DFS by individual RS gene groups (Proliferation Gene Group, HER2 Gene Group, ER Gene Group, Invasion Gene Group, and Other Genes) will be estimated in each arm. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 5-year Disease-free Survival | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years | All eligible patients who had on-study data and follow-up data were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | 5-year Distant Recurrence-free Interval | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years | All eligible patients who had on-study data and follow-up data | percentage of participants | NUMBER |
| SECONDARY | 5-year Recurrence-free Interval | Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years | All eligible patients who had on-study data and follow-up data were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | 5-year Overall Survival | Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years | All eligible patients who had on-study data and follow-up data were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | 5-year Disease-free Survival by Age and Recurrence Score Groups | Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years | All eligible patients who had on-study data and follow-up data were included in the analysis | percentage of participants | NUMBER |
| SECONDARY | To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test | Assessed at 10 years after study entry | Outcome will never be analyzed. | ||
| SECONDARY | 5-year Disease-free Survival by Individual RS Gene Groups | Assessed every 6 months within 5 years from registration and then annually up to 20 years |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 5-year Disease-free Survival | Arm A | 94.0 | 95% Confidence Interval 92.6 to 95.1 | percentage of participants | |
| 5-year Disease-free Survival | Arm B | 92.8 | 95% Confidence Interval 91.8 to 93.6 | percentage of participants | |
| 5-year Disease-free Survival | Arm C | 93.1 | 95% Confidence Interval 92.1 to 93.9 | percentage of participants | |
| 5-year Disease-free Survival | Arm D | 87.6 | 95% Confidence Interval 85.5 to 89.4 | percentage of participants | |
| 5-year Distant Recurrence-free Interval | Arm A | 99.3 | 95% Confidence Interval 98.8 to 99.6 | percentage of participants | |
| 5-year Distant Recurrence-free Interval | Arm B | 98.0 | 95% Confidence Interval 97.4 to 98.4 | percentage of participants | |
| 5-year Distant Recurrence-free Interval | Arm C | 98.2 | 95% Confidence Interval 97.6 to 98.6 | percentage of participants | |
| 5-year Distant Recurrence-free Interval | Arm D | 93.0 | 95% Confidence Interval 91.4 to 94.4 | percentage of participants | |
| 5-year Recurrence-free Interval | Arm A | 98.8 | 95% Confidence Interval 98.1 to 99.2 | percentage of participants | |
| 5-year Recurrence-free Interval | Arm B | 96.9 | 95% Confidence Interval 96.2 to 97.4 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 1,629 | |
| Overall Study | STARTED | Arm B | 3,458 | |
| Overall Study | STARTED | Arm C | 3,449 | |
| Overall Study | STARTED | Arm D | 1,737 | |
| Overall Study | No On-study Data | Arm A | 0 | |
| Overall Study | No On-study Data | Arm B | 2 | |
| Overall Study | No On-study Data | Arm C | 10 | |
| Overall Study | No On-study Data | Arm D | 172 | |
| Overall Study | Ineligible | Arm A | 3 | |
| Overall Study | Ineligible | Arm B | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | 0 | 0 |
| Total, all-cause mortality | Arm B | 0 | 0 |
| Total, all-cause mortality | Arm C | 0 | 0 |
| Total, all-cause mortality | Arm D | 0 | 0 |
| Total, other adverse events | Arm A | 0 | 0 |
| Total, other adverse events | Arm B | 0 | 0 |
| Total, other adverse events | Arm C | 0 | 0 |
| Total, other adverse events | Arm D | 0 | 0 |
| Total, serious adverse events | Arm A | 0 | 0 |
| Total, serious adverse events | Arm B | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180820 | ECOG-ACRIN Network Group Operations Center | ODwyer, Peter J; SCHNALL, MITCHELL D. | ECOG-ACRIN MEDICAL RESEARCH FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00310180
GET https://conductscience.org/api/trials/v1/NCT00310180/results?page=2