Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
|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: NCT01276041|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2011
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: pertuzumab in combination with trastuzumab and paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer|
|Actual Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: pertuzumab in combination with trastuzumab and paclitaxel
This is a phase II study of pertuzumab in combination with trastuzumab and paclitaxel for the treatment of patients with Stage IV HER2 (+) breast cancer.
Drug: pertuzumab in combination with trastuzumab and paclitaxel
The regimen will consist of paclitaxel (80 mg/m2) weekly + trastuzumab every 3 weeks (8 mg/kg loading dose → 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose → 420 mg), all given intravenously (IV). Patients may be given trastuzumab weekly in lieu of every 3 weeks (4 mg/kg loading dose → 2 mg/kg every 3 weeks). Patients will be on treatment until progression of disease.
- The proportion of patients who are progression free at 6 months or later. [ Time Frame: 6 months ]Patients who are considered progression-free at 6 months are deemed successes. Failures are those patients who progressed before the 6 month mark.
- The secondary objectives will be response will include the response rate using the RECIST criteria (version 1.1) [ Time Frame: every 4th cycle CT of chest and abdomen +/- pelvis ]EOD evaluation will consist of a CT of chest and abdomen +/- pelvis. Bone scan and PET are optional. Every 4th cycle, this can be done within +/- 2 weeks.
- The secondary objectives will be safety (including cardiac safety)Study blood will be collected serially for cardiac biomarker analysis (TnI, BNP) and banked for future studies. [ Time Frame: baseline and every 4th cycle of treatment ]We will also assess the LVEF at baseline and after every 4th cycle of treatment with an ECHO with a strain imaging analysis. When an ECHO cannot be done, a MUGA scan may be done.Patients who have surpassed the 6 month period may complete ECHO with strain imaging analysis or MUGA every 6 months +/- 1 month starting from the most recent ECHO scan date. This study will use the NCI Common Toxicity Criteria (CTC) AE version 4.0 for toxicity.
- The secondary objectives will be tolerability. [ 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): NCT01276041
|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 Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan Kettering West Harrison|
|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|