Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
|ClinicalTrials.gov Identifier: NCT01276041|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2011
Last Update Posted : January 30, 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 2019|
|Estimated Study Completion Date :||January 2019|
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.
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|