NCT01358877 · OUTCOME
Trough Serum Concentration (Cmin) 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
- micrograms per milliliter (mcg/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1, 10 and 15 (Cycle length=21 days)
Analysis population: Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. 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 | 31 |
|---|
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 68.0 | 16.6 | Not reported | Not reported | Not reported |
|---|
Cycle 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 31 |
|---|
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 88.1 | 34.4 | Not reported | Not reported | Not reported |
|---|
Cycle 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 27 |
|---|
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pertuzumab + Trastuzumab + Chemotherapy | 95.5 | 51.5 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.6
- value
- 68.0
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 34.4
- value
- 88.1
- title
- Cycle 10
- categories
- measurements
- group Id
- OG000
- spread
- 51.5
- value
- 95.5
- 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
- Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. 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
- Trough Serum Concentration (Cmin) of Pertuzumab
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter (mcg/mL)
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