TriangleNCT01242800 · OUTCOME
3-year Cumulative Incidence of Locoregional Recurrence/Progression
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 at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
What was measured
For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.
Analysis population: All randomized patients at step 2
Groups in this outcome
Arm I (Continued Systemic Therapy)
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
Arm II (Early Local Therapy)
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
| Group | Source count |
|---|---|
| Arm I (Continued Systemic Therapy) | 131 |
| Arm II (Early Local Therapy) | 125 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Continued Systemic Therapy) | 16.3 | Not reported | 10.7 | 24.4 | Not reported |
| Arm II (Early Local Therapy) | 39.8 | Not reported | 31.8 | 49.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.7
- upper Limit
- 24.4
- value
- 16.3
- group Id
- OG001
- lower Limit
- 31.8
- upper Limit
- 49.1
- value
- 39.8
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
- id
- OG000
- title
- Arm I (Continued Systemic Therapy)
- description
- Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
- id
- OG001
- title
- Arm II (Early Local Therapy)
- param Type
- NUMBER
- population Description
- All randomized patients at step 2
- reporting Status
- POSTED
- time Frame
- Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years
- title
- 3-year Cumulative Incidence of Locoregional Recurrence/Progression
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice