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Trial record 55 of 172 for:    pertuzumab

A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

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ClinicalTrials.gov Identifier: NCT00875979
Recruitment Status : Completed
First Posted : April 6, 2009
Results First Posted : July 18, 2013
Last Update Posted : December 24, 2013
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breast Cancer
Interventions Drug: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg
Drug: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg
Drug: Pertuzumab 420 mg
Enrollment 67
Recruitment Details There were 2 phases in the study, a Dose Escalation phase (Phase 1b) and a Dose Expansion phase (Phase 2a).
Pre-assignment Details  
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Hide Arm/Group Description Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle. Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Period Title: Dose Escalation Phase - 3.0 mg/kg
Started 3 0
Completed 0 0
Not Completed 3 0
Reason Not Completed
Disease Progression             1             0
Physician Decision             1             0
Patient/Legal Guardian Decision             1             0
Period Title: Dose Escalation Phase - 3.6 mg/kg
Started 0 6
Completed 0 0
Not Completed 0 6
Reason Not Completed
Disease Progression             0             6
Period Title: Dose Expansion Phase - 3.6 mg/kg
Started 0 58
Completed 0 11
Not Completed 0 47
Reason Not Completed
Disease Progression             0             37
Physician Decision             0             3
Patient/legal Guardian Decision             0             3
Started Non-protocol Anti-Cancer Therapy             0             3
Death             0             1
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg Total
Hide Arm/Group Description Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle. Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle. Total of all reporting groups
Overall Number of Baseline Participants 3 64 67
Hide Baseline Analysis Population Description
Treated population: All patients who received at least 1 dose of study drug and had at least 1 follow-up tumor assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 64 participants 67 participants
53.3  (1.5) 52.7  (10.8) 52.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 64 participants 67 participants
Female
3
 100.0%
63
  98.4%
66
  98.5%
Male
0
   0.0%
1
   1.6%
1
   1.5%
1.Primary Outcome
Title Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Time Frame Baseline through the end of the study (up to 2 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated population: All enrolled patients who had baseline measureable disease.
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Overall Number of Participants Analyzed 3 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
66.7
(13.5 to 98.3)
40.6
(28.5 to 53.6)
2.Secondary Outcome
Title Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Time Frame Baseline through the end of the study (up to 2 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated population: All enrolled patients who had baseline measureable disease. Only patients with an objective response were included in the analysis.
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Overall Number of Participants Analyzed 2 26
Median (95% Confidence Interval)
Unit of Measure: Months
8.6 [1] 
(NA to NA)
13.9 [2] 
(6.93 to NA)
[1]
The confidence interval could not be estimated due to the small sample size.
[2]
The upper limit of the confidence interval could not be estimated due to the small sample size.
3.Secondary Outcome
Title Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
Time Frame Baseline through the end of the study (up to 2 years 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Treated population: All enrolled patients.
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Hide Arm/Group Description:
Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
Overall Number of Participants Analyzed 3 64
Median (95% Confidence Interval)
Unit of Measure: Months
13.8 [1] 
(NA to NA)
6.6
(4.21 to 9.46)
[1]
The confidence interval could not be estimated due to the small sample size.
Time Frame From informed consent until treatment start (T), serious adverse events (SAE) related to protocol procedures were reported. From the start up to 30 days after the end of T, all AEs and SAEs were reported. Thereafter, only T-related SAEs were reported.
Adverse Event Reporting Description Safety population: All patients who received at least 1 dose of study drug.
 
Arm/Group Title Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Hide Arm/Group Description Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle. Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
All-Cause Mortality
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   22/64 (34.38%) 
Cardiac disorders     
Pericardial effusion  1  0/3 (0.00%)  1/64 (1.56%) 
Tachycardia  1  0/3 (0.00%)  1/64 (1.56%) 
Gastrointestinal disorders     
Nausea  1  0/3 (0.00%)  2/64 (3.13%) 
Vomiting  1  0/3 (0.00%)  2/64 (3.13%) 
Abdominal pain  1  0/3 (0.00%)  2/64 (3.13%) 
Colitis  1  0/3 (0.00%)  1/64 (1.56%) 
Diarrhoea  1  0/3 (0.00%)  1/64 (1.56%) 
Gastritis  1  0/3 (0.00%)  1/64 (1.56%) 
Ileus  1  0/3 (0.00%)  1/64 (1.56%) 
General disorders     
Fatigue  1  0/3 (0.00%)  1/64 (1.56%) 
Pyrexia  1  0/3 (0.00%)  1/64 (1.56%) 
Pain  1  0/3 (0.00%)  1/64 (1.56%) 
Hepatobiliary disorders     
Hepatic cirrhosis  1  0/3 (0.00%)  1/64 (1.56%) 
Infections and infestations     
Cellulitis  1  0/3 (0.00%)  3/64 (4.69%) 
Breast cellulitis  1  0/3 (0.00%)  1/64 (1.56%) 
Pneumonia  1  0/3 (0.00%)  3/64 (4.69%) 
Osteomyelitis  1  0/3 (0.00%)  1/64 (1.56%) 
Localised infection  1  0/3 (0.00%)  1/64 (1.56%) 
Skin infection  1  0/3 (0.00%)  1/64 (1.56%) 
Staphylococcal bacteraemia  1  0/3 (0.00%)  1/64 (1.56%) 
Urinary tract infection  1  0/3 (0.00%)  1/64 (1.56%) 
Metabolism and nutrition disorders     
Diabetic foot  1  0/3 (0.00%)  1/64 (1.56%) 
Failure to thrive  1  0/3 (0.00%)  1/64 (1.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour haemorrhage  1  0/3 (0.00%)  1/64 (1.56%) 
Nervous system disorders     
Cerebral haemorrhage  1  0/3 (0.00%)  1/64 (1.56%) 
Ataxia  1  0/3 (0.00%)  1/64 (1.56%) 
Aphasia  1  0/3 (0.00%)  1/64 (1.56%) 
Renal and urinary disorders     
Renal failure acute  1  0/3 (0.00%)  1/64 (1.56%) 
Haematuria  1  0/3 (0.00%)  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/3 (0.00%)  3/64 (4.69%) 
Dyspnoea  1  0/3 (0.00%)  3/64 (4.69%) 
Pneumonitis  1  0/3 (0.00%)  1/64 (1.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   64/64 (100.00%) 
Blood and lymphatic system disorders     
Thrombocytopenia  1  0/3 (0.00%)  21/64 (32.81%) 
Anaemia  1  2/3 (66.67%)  7/64 (10.94%) 
Neutropenia  1  0/3 (0.00%)  5/64 (7.81%) 
Eye disorders     
Lacrimation increased  1  1/3 (33.33%)  5/64 (7.81%) 
Dry eye  1  0/3 (0.00%)  4/64 (6.25%) 
Gastrointestinal disorders     
Nausea  1  2/3 (66.67%)  32/64 (50.00%) 
Diarrhoea  1  1/3 (33.33%)  25/64 (39.06%) 
Constipation  1  1/3 (33.33%)  21/64 (32.81%) 
Vomiting  1  0/3 (0.00%)  18/64 (28.13%) 
Dyspepsia  1  1/3 (33.33%)  11/64 (17.19%) 
Abdominal pain  1  0/3 (0.00%)  7/64 (10.94%) 
Dry mouth  1  1/3 (33.33%)  6/64 (9.38%) 
Gingival bleeding  1  0/3 (0.00%)  6/64 (9.38%) 
Abdominal pain upper  1  0/3 (0.00%)  4/64 (6.25%) 
General disorders     
Fatigue  1  3/3 (100.00%)  39/64 (60.94%) 
Chills  1  2/3 (66.67%)  20/64 (31.25%) 
Pyrexia  1  1/3 (33.33%)  19/64 (29.69%) 
Mucosal inflammation  1  0/3 (0.00%)  16/64 (25.00%) 
Asthenia  1  1/3 (33.33%)  11/64 (17.19%) 
Oedema peripheral  1  0/3 (0.00%)  7/64 (10.94%) 
Chest pain  1  0/3 (0.00%)  4/64 (6.25%) 
Influenza like illness  1  0/3 (0.00%)  4/64 (6.25%) 
Infections and infestations     
Urinary tract infection  1  0/3 (0.00%)  8/64 (12.50%) 
Upper respiratory tract infection  1  0/3 (0.00%)  5/64 (7.81%) 
Sinusitis  1  0/3 (0.00%)  5/64 (7.81%) 
Cellulitis  1  0/3 (0.00%)  4/64 (6.25%) 
Injury, poisoning and procedural complications     
Contusion  1  0/3 (0.00%)  4/64 (6.25%) 
Investigations     
Aspartate aminotransferase increased  1  0/3 (0.00%)  19/64 (29.69%) 
Alanine aminotransferase increased  1  0/3 (0.00%)  18/64 (28.13%) 
Blood alkaline phosphatase increased  1  0/3 (0.00%)  6/64 (9.38%) 
Blood bilirubin increased  1  0/3 (0.00%)  4/64 (6.25%) 
Haemoglobin decreased  1  0/3 (0.00%)  4/64 (6.25%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/3 (66.67%)  22/64 (34.38%) 
Hypokalaemia  1  0/3 (0.00%)  6/64 (9.38%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/3 (33.33%)  13/64 (20.31%) 
Muscle spasms  1  0/3 (0.00%)  13/64 (20.31%) 
Pain in extremity  1  0/3 (0.00%)  12/64 (18.75%) 
Musculoskeletal pain  1  0/3 (0.00%)  10/64 (15.63%) 
Back pain  1  0/3 (0.00%)  9/64 (14.06%) 
Myalgia  1  1/3 (33.33%)  7/64 (10.94%) 
Neck pain  1  0/3 (0.00%)  6/64 (9.38%) 
Bone pain  1  0/3 (0.00%)  5/64 (7.81%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  4/64 (6.25%) 
Nervous system disorders     
Dysgeusia  1  2/3 (66.67%)  16/64 (25.00%) 
Peripheral sensory neuropathy  1  1/3 (33.33%)  16/64 (25.00%) 
Headache  1  2/3 (66.67%)  16/64 (25.00%) 
Dizziness  1  0/3 (0.00%)  7/64 (10.94%) 
Neuropathy peripheral  1  0/3 (0.00%)  7/64 (10.94%) 
Psychiatric disorders     
Insomnia  1  0/3 (0.00%)  15/64 (23.44%) 
Depression  1  1/3 (33.33%)  9/64 (14.06%) 
Anxiety  1  0/3 (0.00%)  5/64 (7.81%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/3 (33.33%)  24/64 (37.50%) 
Dyspnoea  1  2/3 (66.67%)  14/64 (21.88%) 
Epistaxis  1  2/3 (66.67%)  16/64 (25.00%) 
Rhinorrhoea  1  1/3 (33.33%)  7/64 (10.94%) 
Dysphonia  1  0/3 (0.00%)  6/64 (9.38%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/3 (33.33%)  15/64 (23.44%) 
Pruritus  1  1/3 (33.33%)  10/64 (15.63%) 
Alopecia  1  0/3 (0.00%)  7/64 (10.94%) 
Nail disorder  1  0/3 (0.00%)  5/64 (7.81%) 
Vascular disorders     
Hypertension  1  0/3 (0.00%)  7/64 (10.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00875979     History of Changes
Other Study ID Numbers: BO22495
TDM4373g ( Other Identifier: Genentech )
First Submitted: April 2, 2009
First Posted: April 6, 2009
Results First Submitted: February 22, 2013
Results First Posted: July 18, 2013
Last Update Posted: December 24, 2013