TriangleNCT00310180 · OUTCOME
5-year Disease-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
What was measured
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.
Analysis population: All eligible patients who had on-study data and follow-up data were included in the analysis
Groups in this outcome
Arm A
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
Arm B
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
Arm C
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
Arm D
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
| Group | Source count |
|---|---|
| Arm A | 1619 |
| Arm B | 3399 |
| Arm C | 3312 |
| Arm D | 1389 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A | 94.0 | Not reported | 92.6 | 95.1 | Not reported |
| Arm B | 92.8 | Not reported | 91.8 | 93.6 | Not reported |
| Arm C | 93.1 | Not reported | 92.1 | 93.9 | Not reported |
| Arm D | 87.6 | Not reported | 85.5 | 89.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Description
- This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.
- group Ids
- OG001
- OG002
- non Inferiority Comment
- Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.13
- p Value Comment
- One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.08
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.24
- group Description
- This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.
- group Ids
- OG001
- OG002
- non Inferiority Comment
- Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.13
- p Value Comment
- One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.08
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 92.6
- upper Limit
- 95.1
- value
- 94.0
- group Id
- OG001
- lower Limit
- 91.8
- upper Limit
- 93.6
- value
- 92.8
- group Id
- OG002
- lower Limit
- 92.1
- upper Limit
- 93.9
- value
- 93.1
- group Id
- OG003
- lower Limit
- 85.5
- upper Limit
- 89.4
- value
- 87.6
- denoms
- counts
- group Id
- OG000
- value
- 1619
- group Id
- OG001
- value
- 3399
- group Id
- OG002
- value
- 3312
- group Id
- OG003
- value
- 1389
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 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
- id
- OG000
- title
- Arm A
- description
- 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
- id
- OG001
- title
- Arm B
- description
- 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
- id
- OG002
- title
- Arm C
- description
- 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
- id
- OG003
- title
- Arm D
- param Type
- NUMBER
- population Description
- All eligible patients who had on-study data and follow-up data were included in the analysis
- reporting Status
- POSTED
- time Frame
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years
- title
- 5-year Disease-free Survival
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice