Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
|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.|
|ClinicalTrials.gov Identifier: NCT02252887|
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic HER2-Positive Breast Cancer||Drug: Gemcitabine Drug: Trastuzumab Drug: Pertuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab- or Pertuzumab-Based Therapy|
|Actual Study Start Date :||January 12, 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Gemcitabine, Trastuzumab, and Pertuzuma
The regimen will consist of gemcitabine at 1000mg/m^2 IV weekly days 1 + 8 q 3 weeks + trastuzumab every 3 weeks (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose followed by 420 mg every 3 weeks), all given intravenously (IV). Trastuzumab may be given IV weekly (4 mg/kg loading dose followed by 2 mg/kg weekly) in lieu of the every 3 week schedule. A loading dose of trastuzumab will not be required for patients who have received it < 6 weeks prior to Cycle 1 Day 1.
- progression free [ Time Frame: 3 months ]Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first. The primary endpoint is PFS and secondary endpoint will include the response rate using the RECIST criteria (version 1.1).
- progression-free survival [ Time Frame: 2 years ]Progression-free survival (PFS) is defined from time from treatment assignment to disease progression or death, whichever comes first.
- response [ Time Frame: 2 years ]Response to treatment will be determined using both RECIST and PRC ( PET Response Criteria criteria).
- overall survival [ Time Frame: 2 years ]Progression-free survival and median overall survival will also be estimated by the Kaplan-Meier method.
- safety [ Time Frame: 2 years ]This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252887
|United States, Connecticut|
|Hartford Healthcare Cancer Institute @ Hartford Hospital|
|Hartford, Connecticut, United States, 06102|
|United States, New Jersey|
|Memorial Sloan Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|Memorial Sloan Kettering Monmouth|
|Middletown, New Jersey, United States, 07748|
|United States, New York|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering at Mercy Medical Center|
|Rockville Centre, New York, United States|
|Principal Investigator:||Chau Dang, MD||Memorial Sloan Kettering Cancer Center|