Clinical Trial Results:
A Randomized, Double-Blind Pharmacokinetic Study Of PF 05280014 Plus Taxotere® And Carboplatin Versus Herceptin® Plus Taxotere® And Carboplatin For The Neoadjuvant Treatment Of Patients With Operable HER2 Positive Breast Cancer.
Summary
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EudraCT number |
2013-004679-11 |
Trial protocol |
IT SK CZ HU PL |
Global end of trial date |
09 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Mar 2017
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First version publication date |
16 Mar 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B3271004
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 East 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer CT.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer CT.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Mar 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare the percentage of participants with steady state (Cycle 5) trough plasma concentration (Ctrough) >20 μg/mL for PF 05280014 versus trastuzumab-EU in patients with operable HER2-positive breast cancer who received study therapy together with Taxotere and carboplatin in the neoadjuvant setting.
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Protection of trial subjects |
This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants.
A signed and dated informed consent was required before any screening procedures were done, with the exception of radiographic tumor assessments (which were performed as part of routine procedures within 6 weeks prior to randomization and in accordance with protocol method/documentation requirements).
Appropriate documentation indicating that these radiographic tumor assessments were performed as standard of care were available in the patient’s source notes. The investigators explained the nature, purpose, and risks of the study to each participant. Each participant was informed that she could withdraw from the study at any time and for any reason. Each participant was given sufficient time to consider the implications of the study before deciding whether to participate.
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Background therapy |
Taxotere was administered every 3 weeks on Day 1 of each cycle. The starting dose of Taxotere was 75 mg/m2 administered IV over 60 minutes. Carboplatin was administered every 3 weeks on Day 1 of each cycle. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Sep 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belarus: 2
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Country: Number of subjects enrolled |
Czech Republic: 1
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Country: Number of subjects enrolled |
Hungary: 17
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Country: Number of subjects enrolled |
Italy: 15
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Country: Number of subjects enrolled |
Poland: 25
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Country: Number of subjects enrolled |
Russian Federation: 117
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Country: Number of subjects enrolled |
Serbia: 1
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Country: Number of subjects enrolled |
Slovakia: 4
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Country: Number of subjects enrolled |
Ukraine: 40
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Country: Number of subjects enrolled |
United States: 3
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Worldwide total number of subjects |
225
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EEA total number of subjects |
62
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
183
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From 65 to 84 years |
42
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was initiated at 67 sites in 10 countries (across Europe and the United States [US]), of which 21 sites had no enrollment activity. Advertisements approved by ethics committees and investigator databases may be used as recruitment procedures. All advertisements must have been approved by the study Sponsor prior to use. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Informed consent must have been obtained before any study specific procedures were performed (with the exception of certain imaging assessments if meeting the protocol specified criteria); however, it may be obtained more than 28 days before randomization. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Assessor | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PF-05280014 | ||||||||||||||||||||||||||||||
Arm description |
Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
PF-05280014
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The first administration of PF-05280014 on Day 1, Cycle 1 was a loading dose of 8 mg/kg infused over 90 minutes. The duration of infusion could be lengthened according to local standard of care or tolerability. Subsequent infusions followed every 3 weeks (ie, cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability. In the absence of objective disease progression or prohibitive toxicity, patients received PF-05280014 for 6 cycles.
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Arm title
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Trastuzumab-EU | ||||||||||||||||||||||||||||||
Arm description |
Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Trastuzumab-EU
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The first administration of trastuzumab-EU on Day 1, Cycle 1 was a loading dose of 8 mg/kg infused over 90 minutes. The duration of infusion could be lengthened according to local standard of care or tolerability. Subsequent infusions followed every 3 weeks (ie, cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability. In the absence of objective disease progression or prohibitive toxicity, patients received trastuzumab-EU for 6 cycles.
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Baseline characteristics reporting groups
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Reporting group title |
PF-05280014
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Reporting group description |
Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Trastuzumab-EU
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Reporting group description |
Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PF-05280014
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Reporting group description |
Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle. | ||
Reporting group title |
Trastuzumab-EU
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Reporting group description |
Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. |
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End point title |
Percentage of Participants with Steady State Drug Concentration Ctrough (Cycle 6 pre-dose) >20 µg/mL at Cycle 5. | ||||||||||||
End point description |
The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.
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End point type |
Primary
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End point timeframe |
Cycle 5
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Statistical analysis title |
Estimated difference (stratified) | ||||||||||||
Statistical analysis description |
Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
190
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Analysis specification |
Pre-specified
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Analysis type |
[1] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.76
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-8.02 | ||||||||||||
upper limit |
6.49 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
3.7
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Notes [1] - The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%. |
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Statistical analysis title |
Estimated difference (unstratified) | ||||||||||||
Statistical analysis description |
Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
190
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Analysis specification |
Pre-specified
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Analysis type |
[2] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-1.18
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-8.59 | ||||||||||||
upper limit |
6.23 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
3.78
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Notes [2] - The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%. |
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End point title |
Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 through 6. | |||||||||||||||||||||||||||||||||
End point description |
Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.
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End point type |
Secondary
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End point timeframe |
Cycles 1 through 6
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No statistical analyses for this end point |
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End point title |
Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes. | ||||||||||||
End point description |
Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
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End point type |
Secondary
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End point timeframe |
Cycle 6/End of treatment
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Statistical analysis title |
Estimated difference (stratified) | ||||||||||||
Statistical analysis description |
Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
186
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Analysis specification |
Pre-specified
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Analysis type |
[3] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-2.81
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-16.58 | ||||||||||||
upper limit |
10.96 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
7.03
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Notes [3] - Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status. |
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Statistical analysis title |
Estimated difference (unstratified) | ||||||||||||
Statistical analysis description |
Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
186
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Analysis specification |
Pre-specified
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Analysis type |
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Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-17.4 | ||||||||||||
upper limit |
11.4 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
7.35
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End point title |
Objective Response Rate (ORR) Defined as the Percentage of Participants having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor. | ||||||||||||
End point description |
ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.
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End point type |
Secondary
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End point timeframe |
Cycle 6/End of treatment
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Statistical analysis title |
Estimated difference (stratified) | ||||||||||||
Statistical analysis description |
Stratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
190
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Analysis specification |
Pre-specified
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Analysis type |
[4] | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
5.96
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-4.01 | ||||||||||||
upper limit |
15.94 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5.09
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Notes [4] - Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status. |
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Statistical analysis title |
Estimated difference (unstratified) | ||||||||||||
Statistical analysis description |
Unstratified estimated difference between PF-05280014 and Trastuzuamb-EU.
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Comparison groups |
PF-05280014 v Trastuzumab-EU
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Number of subjects included in analysis |
190
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Analysis specification |
Pre-specified
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Analysis type |
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Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
6.1
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-4.08 | ||||||||||||
upper limit |
16.27 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
5.19
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End point title |
Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 through 6. | |||||||||||||||||||||
End point description |
The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.
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End point type |
Secondary
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End point timeframe |
Cycles 1 through 6
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No statistical analyses for this end point |
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End point title |
Incidence of Neutralizing Antibodies (NAb) at Cycles 1 through 6. | |||||||||||||||||||||
End point description |
The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.
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End point type |
Secondary
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End point timeframe |
Cycles 1 through 6
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Serious adverse events were captured from the beginning of the study drug treatment up to 6 months after the last dose. Treatment emergent adverse events were captured from the beginning of the study drug treatment up to 50 days after the last dose.
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Adverse event reporting additional description |
Treatment emergent adverse events were defined as any adverse event that occurred or any preexisting adverse event that worsened within the reporting time frame.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
PF-05280014
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Reporting group description |
Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Trastuzumab-EU
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Reporting group description |
Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Oct 2014 |
Amendment 1 was implemented as a result of feedback from the E-DMC and Study B3271002 protocol Amendment 2, as well as Pfizer SOP updates. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
It was decided that the secondary study objective to explore the relationship between drug exposure and pCR for PF-05280014 versus trastuzumab-EU would not be analyzed. |