TriangleNCT00545688 · OUTCOME
Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography
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
- Not reported
- Time frame
- Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
What was measured
Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (\>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.
Analysis population: ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.
Groups in this outcome
Trastuzumab+Docetaxel
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
Trastuzumab+Pertuzumab+Docetaxel
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
Trastuzumab+Pertuzumab
Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
Pertuzumab+Docetaxel
Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
| Group | Source count |
|---|---|
| Trastuzumab+Docetaxel | 71 |
| Trastuzumab+Pertuzumab+Docetaxel | 58 |
| Trastuzumab+Pertuzumab | 61 |
| Pertuzumab+Docetaxel | 47 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 18.3 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 19.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 13.1 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 19.1 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 49.3 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 46.6 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 36.1 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 46.8 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 31.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 32.8 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 44.3 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 34.0 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 1.4 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 1.7 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 6.6 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18.3
- group Id
- OG001
- value
- 19.0
- group Id
- OG002
- value
- 13.1
- group Id
- OG003
- value
- 19.1
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 49.3
- group Id
- OG001
- value
- 46.6
- group Id
- OG002
- value
- 36.1
- group Id
- OG003
- value
- 46.8
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 31.0
- group Id
- OG001
- value
- 32.8
- group Id
- OG002
- value
- 44.3
- group Id
- OG003
- value
- 34.0
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 1.4
- group Id
- OG001
- value
- 1.7
- group Id
- OG002
- value
- 6.6
- group Id
- OG003
- value
- 0.0
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 61
- group Id
- OG003
- value
- 47
- units
- Participants
- description
- Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of '0' is noted at a given cycle as compared to baseline measurement which is greater than (\>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline.
- groups
- description
- Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
- id
- OG000
- title
- Trastuzumab+Docetaxel
- description
- Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17.
- id
- OG001
- title
- Trastuzumab+Pertuzumab+Docetaxel
- description
- Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m\^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m\^2 for three cycles (Cycles 6-8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17.
- id
- OG002
- title
- Trastuzumab+Pertuzumab
- description
- Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m\^2 on Day 1 of Cycle 1 followed by 100 mg/m\^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred. Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5-7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21.
- id
- OG003
- title
- Pertuzumab+Docetaxel
- param Type
- NUMBER
- population Description
- ITT Population; Analysis was performed according to initial randomization. Number of participants analyzed = participants evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
- title
- Percentage of Participants Achieving Best Primary Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Disease Progression [PD]) During Neo-Adjuvant Treatment by X-Ray/Mammography
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice