TDM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer (STELA)
This open-label, single-center study will assess the safety and tolerability of combining trastuzumab emtansine (T-DM1) to Lapatinib and Abraxane in patients with metastatic HER2-positive breast cancer. Patients will receive Abraxane on Day 1 of each 1-week cycle and T-DM1 on Day 1 of each 3-week cycle. Patients with take Lapatinib orally daily. Anticipated time on study treatment is up to 12 weeks for patients metastatic breast cancer, until disease progression or unacceptable toxicity occurs. Subjects may continue on treatment past 12 weeks if responding to study treatment.
The purpose of this study is to test the safety of Trastuzumab Emtansine in combination with Abraxane and Lapatinib at different dose levels. The investigators are proposing in this phase Ib study to assess the maximum tolerated dose (MTD) of Trastuzumab Emtansine in combination with Lapatinib plus Abraxane in metastatic Her2 over-expressed breast cancer.
The investigators hypothesize that combining antibody-drug conjugate trastuzumab-emtansine and lapatinib together with Abraxane will improve clinical efficacy by affecting both PI3K and ERK1,2 MAPK pathways.
|Metastatic Breast Cancer||Drug: TDM1 Drug: Lapatinib Drug: Abraxane||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ib Trial of Trastuzumab Emtansine In Combination With Lapatinib Plus Abraxane In Metastatic Her 2 Neu Over-Expressed Breast Cancer Patients|
- 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.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: TDM1 with Lapatinib followed by Abraxane
TDM1 with Laptinib followed by Abraxane
•Drug: abraxane Intravenous repeating dose weekly
Other Names:Drug: Lapatinib
Oral repeating dose daily
Other Name: TykerbDrug: Abraxane
Intravenous repeating dose weekly
Please refer to this study by its ClinicalTrials.gov identifier: NCT02073916
|Contact: Houston Methodist Cancer Centeremail@example.com|
|United States, Texas|
|Houston Methodist Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Cancer Center 713-441-0629 firstname.lastname@example.org|
|Principal Investigator: Jenny CN Chang, MD|
|Sub-Investigator: Angel A Rodriguez, MD|
|Sub-Investigator: Tejal Patel, MD|
|Sub-Investigator: Daniel Lehane, MD|
|Sub-Investigator: Monisha Singh, MD|
|Sub-Investigator: Jorge Darcourt, MD|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital System|