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Trastuzumab and Vinorelbine in Advanced Breast Cancer

This study has been terminated.
(Not enough confirmed responses to continue treatment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185509
First Posted: August 20, 2010
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Metastatic Breast Cancer
Interventions: Drug: trastuzumab
Drug: vinorelbine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from November 2010 through July 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trastuzumab and Vinorelbine - Cohort A Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Trastuzumab and Vinorelbine - Main Cohort Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.

Participant Flow:   Overall Study
    Trastuzumab and Vinorelbine - Cohort A   Trastuzumab and Vinorelbine - Main Cohort
STARTED   11   20 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   11   20 
Progression/Relapse                9                15 
Physician Decision                2                2 
Withdrawal by Subject                0                1 
Death                0                1 
Intercurrent Illness                0                1 
[1] Since treatment was not of fixed duration, all participants were considered as 'Not Completed'.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis dataset is comprised of all treated patients.

Reporting Groups
  Description
Trastuzumab and Vinorelbine - Cohort A Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Trastuzumab and Vinorelbine - Main Cohort Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Total Total of all reporting groups

Baseline Measures
   Trastuzumab and Vinorelbine - Cohort A   Trastuzumab and Vinorelbine - Main Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   20   31 
Age 
[Units: Years]
Median (Full Range)
 50 
 (26 to 78) 
 54 
 (34 to 66) 
 54 
 (26 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11 100.0%      20 100.0%      31 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   20   31 
Estrogen Receptor Status at Metastatic Diagnosis 
[Units: Participants]
Count of Participants
     
Positive   9   8   17 
Negative   2   5   7 
Unknown   0   7   7 
Progesterone Receptor Status at Metastatic Diagnosis 
[Units: Participants]
     
Positive   4   4   8 
Negative   7   9   16 
Unknown   0   7   7 


  Outcome Measures
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1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67). ]

2.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67). ]

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months. ]

4.  Secondary:   Circulating Tumor Cells (CTCs)   [ Time Frame: Assessed at baseline ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  

5.  Secondary:   Circulating Tumor Cells (CTCs)   [ Time Frame: Assessed at 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  

6.  Secondary:   Circulating Tumor Cells (CTCs)   [ Time Frame: Assessed when patient comes off-study ]
Results not yet reported.   Anticipated Reporting Date:   09/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study terminated early due to insufficient response per statistical design.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Ian Krop, MD, PhD
Organization: Dana-Farber Cancer Institute
phone: 617.632.6973
e-mail: Ian_Krop@dfci.harvard.edu



Responsible Party: Ian E. Krop, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01185509     History of Changes
Other Study ID Numbers: 10-207
H4913s ( Other Identifier: Genentech, Inc )
First Submitted: August 18, 2010
First Posted: August 20, 2010
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: August 28, 2017