T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA)
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|ClinicalTrials.gov Identifier: NCT02073916|
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: T-DM1 Drug: Lapatinib Drug: Abraxane||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
Experimental: T-DM1 + Lapatinib + Abraxane
T-DM1 with Laptinib followed by Abraxane
antibody-drug conjugate of trastuzumab and emtansine
Dual tyrosine kinase inhibitor (HER2 and EGFR)
Other Name: Tykerb
albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
Other Name: nab-paclitaxel
- Maximum Tolerable Dose [ Time Frame: approximately 16 weeks ]Maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
- Dose Limiting Toxicities [ Time Frame: From date of randomization through study follow up (approximately 16 weeks) ]Describe the dose-limiting toxicity (DLT) associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
- Measure toxicities associated with treatment combination [ Time Frame: From date of randomization through study follow up (approximately 16 weeks) ]Describe and measure other toxicities associated with Trastuzumab Emtansine in combination with Lapatinib plus Abraxane as assessed by CTCAE v4.0.
- Anti-tumor activity through imaging [ Time Frame: approximately 16 weeks from randomization ]Document anti-tumor activity of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer as assessed by RECIST 1:1 criteria
- Plasma pharmacokinetics and pharmacodynamic effect of treatment combination [ Time Frame: Day 1 and 1,2,4,and 24hours ]Determine the plasma pharmacokinetics of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane.
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): NCT02073916
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital System|