Patients with metastatic breast cancer treated with approved trastuzumab and pertuzumab
Research type
Research Study
Full title
A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients. (The DEMETHER Study).
IRAS ID
1010630
Contact name
Carlos Martinelli
Contact email
Sponsor organisation
Medica Scientia Innovation Research (MEDSIR)
Eudract number
2023-507306-13
Research summary
This is a Phase II study which examines recurring unresectable or metastatic breast cancer in both adult (+18) male and female participants that are human epidermal growth factor receptor 2- positive (HER2) The study aims to address the unmet medical need in patients who experience progression following endocrine therapy by evaluating the advantage and safety of using Trastuzumab Deruxtecan as Induction Treatment followed by a maintenance course of Trastuzumab and Pertuzumab. The study will provide valuable insights into the potential benefits and risks.
Participants will be enrolled into a single group which will dispense Trastuzumab Deruxtecan (T-DXd) as an induction treatment followed by PHESGO which is a combination of Trastuzumab and Pertuzumab treatment. Inclusion into the study requires participants to be over 18 years of age, open to both male and female, have been diagnosed with locally recurrent or metastatic breast cancer which is HER 2- positive in origin.
We have two NHS hospital sites selected to participate in the study with Barts Health NHS Trust being the CI site. These sites have been chosen for their experience in the treatment of the above mentioned cancer type and Barts Health accommodates the chief investigator of the study.
Typically Participants enrolled onto the study will undertake a full screening visit, CT scan, haematology, blood chemistry, Medical history review, physical examination, a review of current medications, ECG and adverse events that the participant may experience during the course of the study. Once enrolled the patient attends clinical for the induction phase which lasts for 6 cycles (every 3 weeks). Once the induction phase has been completed the patient will move onto the maintenance phase until completion of 3 years in treatment. The maintenance treatment will be administered every 3 weeks. A safety follow up will be conducted 28 days after the last dose administered to the patient.REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0022
Date of REC Opinion
27 Jan 2025
REC opinion
Further Information Favourable Opinion