Clinical Trials Logo
  1. Home
  2. HER-2 Positive Breast Cancer
  3. NCT01565200

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1 — ZEPHIR  

HER-2 Positive Breast Cancer Clinical Trial

Official title:
Phase II Prospective Imaging Study Evaluating the Utility of Pre-treatment zr89 Labelled Trastuzumab PET/CT and an Early FDG-PET/CT Response to Identify Patients With Advanced HER2+ BC Unlikely to Benefit From a Novel antiHER2 Therapy: TDM1

Clinical Trial Summary

T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor activity evaluated by Recist criteria (35% objective response rate, 44% stable disease, 18% progressive disease) in patients with advanced HER2 positive Breast Cancer pretreated with several cytotoxic drugs, trastuzumab and lapatinib. Rationale I :For TDM1 to be active, the presence of an intact HER2 receptor is "key" since the internalization of the cytotoxic moiety depends on the binding of trastuzumab to the external domain of HER2. The zirconium 89 labelled trastuzumab PET/CT (or HER2 immunoPET/CT) is a non invasive test which shows promise in measuring HER2 expression (extracellular domain) for the entire disease burden and which could identify non responding patients prior to TDM1 administration. Rationale II: As for many such agents, it is desirable to identify early on (here with the use of FDG-PET/CT) which patients are unlikely to benefit from the therapy

Clinical Trial Description

The main objective of the trial is to prospectively evaluate the ability of a zirconium 89 labelled trastuzumab PET, to predict, before initiation of the treatment, treatment failure to a new targeted drug: T-DM1. At the same time, the early FDG-PET/CT, performed after 1 course of T-DM1, will also evaluated for its ability to predict non response to TDM1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01565200
Study type Interventional
Source Jules Bordet Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 2012
Completion date June 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT01305941 - A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases Phase 2
Completed NCT01432223 - Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab Phase 2
Completed NCT01433926 - Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years N/A
Recruiting NCT05871918 - A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer Phase 3
Terminated NCT02598310 - Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer Phase 2
Active, not recruiting NCT02568839 - Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer Phase 2/Phase 3
Completed NCT02675231 - A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer Phase 2
Terminated NCT02154529 - Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01340430 - Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer Phase 2
Active, not recruiting NCT02947685 - Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer Phase 3
Completed NCT02066532 - Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer Phase 1/Phase 2
Completed NCT01583426 - Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) Phase 3
Completed NCT01677455 - An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer Phase 2
Withdrawn NCT01361945 - AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer Phase 1/Phase 2
Active, not recruiting NCT02326974 - T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA Phase 2
Not yet recruiting NCT04644406 - PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
Terminated NCT02131506 - A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer Phase 1
Completed NCT00788931 - A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Phase 1
Completed NCT02488564 - A Study of Liposomal Doxorubicin + Docetaxel + Trastuzumab + Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer Phase 2
Completed NCT02492711 - Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Phase 3