NCT01358877 · OUTCOME
Peak Serum Concentration (Cmax) of Pertuzumab
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer · Source last updated 2025-11-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1, 10 and 15 (Cycle length=21 days)
Analysis population: PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
Groups in this outcome
Pertuzumab + Trastuzumab + Chemotherapy
Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 36 |
|---|
Reported measurements
Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 33 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 237 | 118 | Not reported | Not reported | Not reported |
|---|
Cycle 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 29 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 222 | 92.2 | Not reported | Not reported | Not reported |
|---|
Cycle 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 24 |
|---|
Values in mcg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 206 | 94.9 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 118
- value
- 237
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 92.2
- value
- 222
- title
- Cycle 10
- categories
- measurements
- group Id
- OG000
- spread
- 94.9
- value
- 206
- title
- Cycle 15
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
- id
- OG000
- title
- Pertuzumab + Trastuzumab + Chemotherapy
- param Type
- MEAN
- population Description
- PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Cycles 1, 10 and 15 (Cycle length=21 days)
- title
- Peak Serum Concentration (Cmax) of Pertuzumab
- type
- SECONDARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle