TriangleNCT00545688 · OUTCOME
Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination
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, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
What was measured
Tumor assessments were made based on the 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 \>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% 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. Overall response is derived based on the sum total of breast tumors and all nodes examined.
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 | 99 |
| Trastuzumab+Pertuzumab+Docetaxel | 101 |
| Trastuzumab+Pertuzumab | 102 |
| Pertuzumab+Docetaxel | 91 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 23.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 30.7 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 20.9 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 56.6 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 57.4 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 51.0 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 50.5 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 20.2 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 11.9 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 30.4 | Not reported | Not reported | Not reported | Not reported |
| Pertuzumab+Docetaxel | 28.6 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trastuzumab+Docetaxel | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab+Docetaxel | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Trastuzumab+Pertuzumab | 2.0 | 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
- 23.2
- group Id
- OG001
- value
- 30.7
- group Id
- OG002
- value
- 16.7
- group Id
- OG003
- value
- 20.9
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 56.6
- group Id
- OG001
- value
- 57.4
- group Id
- OG002
- value
- 51.0
- group Id
- OG003
- value
- 50.5
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 20.2
- group Id
- OG001
- value
- 11.9
- group Id
- OG002
- value
- 30.4
- group Id
- OG003
- value
- 28.6
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 2.0
- group Id
- OG003
- value
- 0.0
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 101
- group Id
- OG002
- value
- 102
- group Id
- OG003
- value
- 91
- units
- Participants
- description
- Tumor assessments were made based on the 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 \>0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% 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. Overall response is derived based on the sum total of breast tumors and all nodes examined.
- 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, Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months
- title
- Percentage of Participants Achieving Best Primary Breast Tumor Response (CR, PR, SD or PD) During Neo-Adjuvant Period by Clinical Examination
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice