TriangleNCT00310180 · OUTCOME
5-year Distant Recurrence-free Interval
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, DRFI rate estimated at 5 years
What was measured
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.
Analysis population: All eligible patients who had on-study data and follow-up data
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 | 99.3 | Not reported | 98.8 | 99.6 | Not reported |
| Arm B | 98.0 | Not reported | 97.4 | 98.4 | Not reported |
| Arm C | 98.2 | Not reported | 97.6 | 98.6 | Not reported |
| Arm D | 93.0 | Not reported | 91.4 | 94.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 98.8
- upper Limit
- 99.6
- value
- 99.3
- group Id
- OG001
- lower Limit
- 97.4
- upper Limit
- 98.4
- value
- 98.0
- group Id
- OG002
- lower Limit
- 97.6
- upper Limit
- 98.6
- value
- 98.2
- group Id
- OG003
- lower Limit
- 91.4
- upper Limit
- 94.4
- value
- 93.0
- 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
- 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.
- 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
- reporting Status
- POSTED
- time Frame
- Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years
- title
- 5-year Distant Recurrence-free Interval
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice