Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel (TEAL)
|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: NCT02073487|
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: T-DM1 Drug: Trastuzumab Drug: Lapatinib Drug: Abraxane Drug: Paclitaxel Drug: Pertuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Open Label PhII Trial of Neoadjuvant Trastuzumab Emtansine (Te) in Combination w/Lapatinib (L) Followed by Abraxane (A) Compared w/Trastuzumab Plus Pertuzumab Followed by Paclitaxel in Her2/Neu Over-Expressed Breast Cancer Patients|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2019|
Experimental: T-DM1 + Lapatinib + Abraxane
T-DM1 intravenously (IV) every three weeks plus L orally once daily for 6 weeks followed by abraxane IV weekly for 12 weeks.
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
Active Comparator: Trastuzumab + Pertuzumab + Paclitaxel
Trastuzumab IV weekly plus pertuzumab IV every 3 weeks for 6 weeks, followed by paclitaxel IV weekly for 12 weeks.
anti-Her2 monoclonal antibody
Other Name: Herceptin
chemotherapy - microtubule inhibitor
Other Name: Taxol
anti-HER2 monoclonal antibody
Other Name: Perjeta
- pathological complete response rate (pCR) [ Time Frame: From date of randomization until the date of surgery, approximately 16 weeks ]To evaluate the pathological complete response rate (pCR) in the breast after treatment with Trastuzumab Emtansine plus Lapatinib follow by Abraxane in women with HER2 Neu over-expressed breast cancer patients.
- Clinical Response Rate [ Time Frame: From date of randomization until completion of neoadjuvant treatment, approximately 16 weeks ]To determine the clinical response rate in patients with palpable disease.
- breast imaging response to treatment [ Time Frame: approximately 16 weeks ]To determine the imaging response to neoadjuvant therapy through breast imaging (mammogram, ultrasound and MRI) using RECIST.
- objective response rate [ Time Frame: approximately 16 weeks ]To compare overall objective response rate in both treatment groups.
- toxicity, safety and efficacy of study treatment [ Time Frame: approximately 16 weeks from randomization ]To assess toxicity, safety and efficacy of Trastuzumab Emtansine when combine with Lapatinib follow by Abraxane
- determine predictive markers [ Time Frame: approximately 1 year ]To determine predictive markers for sensitivity and resistance to Trastuzumab Emtansine when combined with Lapatinib follow by 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): NCT02073487
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Houston Methodist Hospital Willowbrook|
|Houston, Texas, United States, 77070|
|Houston Methodist Hospital Sugar Land|
|Sugar Land, Texas, United States, 77479|
|Principal Investigator:||Jenny C Chang, MD||The Methodist Hospital System|