NCT02073487

Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L)followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer.

Detailed description

This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L) followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, trastuzumab emtansine plus lapatinib for 6 weeks, followed by trastuzumab emtansine plus lapatinib plus abraxane for 12 weeks; arm 2, trastuzumab plus pertuzumab for six weeks, followed by trastuzumab plus pertuzumab plus paclitaxel for 12 weeks. Patients will undergo surgery after neoadjuvant therapy. All patients will have a core needle biopsy at baseline, after week 6, and at the time of disease progression. Surgical specimens will be obtained after week 18.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	T-DM1	antibody-drug conjugate of trastuzumab and emtansine
DRUG	Trastuzumab	anti-Her2 monoclonal antibody
DRUG	Lapatinib	Dual tyrosine kinase inhibitor (HER2 and EGFR)
DRUG	Abraxane	albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.
DRUG	Paclitaxel	chemotherapy - microtubule inhibitor
DRUG	Pertuzumab	anti-HER2 monoclonal antibody

Timeline

• Start date: 2014-02-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2014-02-27
• Last updated: 2021-09-22
• Results posted: 2021-09-22

Locations

3 sites across 1 country: United States