TriangleNCT00310180 · STUDY IN CONTEXT
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- trial label
- Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0000
- source section id
- NCT00310180-om-0000
- source outcome index
- 0
- endpoint
- 5-year Disease-free Survival
- endpoint definition
- 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.
- time origin
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who had on-study data and follow-up data were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0001
- source section id
- NCT00310180-om-0001
- source outcome index
- 1
- endpoint
- 5-year Distant Recurrence-free Interval
- endpoint definition
- 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.
- time origin
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who had on-study data and follow-up data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0002
- source section id
- NCT00310180-om-0002
- source outcome index
- 2
- endpoint
- 5-year Recurrence-free Interval
- endpoint definition
- 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.
- time origin
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who had on-study data and follow-up data were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0003
- source section id
- NCT00310180-om-0003
- source outcome index
- 3
- endpoint
- 5-year Overall Survival
- endpoint definition
- 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.
- time origin
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who had on-study data and follow-up data were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0004
- source section id
- NCT00310180-om-0004
- source outcome index
- 4
- endpoint
- 5-year Disease-free Survival by Age and Recurrence Score Groups
- endpoint definition
- 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.
- time origin
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients who had on-study data and follow-up data were included in the analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0005
- source section id
- NCT00310180-om-0005
- source outcome index
- 5
- endpoint
- To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test
- endpoint definition
- Adjuvant! is not currently available; additional work combining classical information with genomic tests will be reported separately.
- time origin
- Assessed at 10 years after study entry
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Outcome will never be analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A
- regimen
- Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 1619
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 3399
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm C
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 3312
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Arm D
- regimen
- Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 1389
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A
- regimen
- Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 1619
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 3399
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm C
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 3312
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Arm D
- regimen
- Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 1389
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A
- regimen
- Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 1619
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
- analyzed count
- 3399
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm C
- regimen
- Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 3312
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Arm D
- regimen
- Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
- analyzed count
- 1389
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00310180-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- harm key
- EG000
- source section id
- NCT00310180-ae
- event group key
- EG000
- event group label
- Arm A
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- event definition
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- harm key
- EG001
- source section id
- NCT00310180-ae
- event group key
- EG001
- event group label
- Arm B
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- event definition
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- harm key
- EG002
- source section id
- NCT00310180-ae
- event group key
- EG002
- event group label
- Arm C
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- event definition
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer
- nct id
- NCT00310180
- harm key
- EG003
- source section id
- NCT00310180-ae
- event group key
- EG003
- event group label
- Arm D
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 5
- collection period
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- event definition
- Both the chemotherapy and endocrine therapy given on this study were standard therapies for this population. To simplify the effort required for participating sites, adverse event data were not collected.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice