TriangleNCT00950300 · OUTCOME
Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- μg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
What was measured
Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).
Analysis population: Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.
Groups in this outcome
Herceptin IV + Chemotherapy
Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
Herceptin SC + Chemotherapy
Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
| Group | Source count |
|---|---|
| Herceptin IV + Chemotherapy | 235 |
| Herceptin SC + Chemotherapy | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Herceptin IV + Chemotherapy | 57.8 | 30.3 | Not reported | Not reported | Not reported |
| Herceptin SC + Chemotherapy | 78.7 | 43.9 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.44
- estimate Comment
- Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).
- group Description
- PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Geometric mean ratio
- param Value
- 1.33
Complete source fields
- analyses
- ci Lower Limit
- 1.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.44
- estimate Comment
- Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).
- group Description
- PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Geometric mean ratio
- param Value
- 1.33
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 30.3
- value
- 57.8
- group Id
- OG001
- spread
- 43.9
- value
- 78.7
- denoms
- counts
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 234
- units
- Participants
- description
- Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
- id
- OG000
- title
- Herceptin IV + Chemotherapy
- description
- Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
- id
- OG001
- title
- Herceptin SC + Chemotherapy
- param Type
- MEAN
- population Description
- Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.
- reporting Status
- POSTED
- time Frame
- Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)
- title
- Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery
- type
- PRIMARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice