MiRaDoR
Research type
Research Study
Full title
A proof of concept study to evaluate treatments’ efficacy by monitoring Minimal Residual Disease using ctDNA in HR-positive/HER2-negative early breast cancer population.
IRAS ID
1007314
Contact name
Susana Vitorino
Contact email
Sponsor organisation
Medica Scientia Innovation Research, S.L. (MEDSIR)
Eudract number
2022-002616-24
Clinicaltrials.gov Identifier
Research summary
The study aims to evaluate treatments’ anticancer efficacy by monitoring the number of cancer cells left in the body after anticancer treatment. The patient population will comprise men/women aged ≥18 years with early-stage HR-positive/HER2-negative breast cancer at high risk of relapse but with no evidence that cancer has spread. The study is a phase 2, open-label, multicentre, non-comparative trial comprising two phases. Patients will first enter a surveillance phase. Blood will be collected periodically to monitor the absence or presence of circulating tumour DNA (ctDNA) in the bloodstream whilst participants continue to take ET as prescribed. If the ctDNA result turns positive, then patients will be screened to enter the treatment phase. Surveillance phase: number of visits is between 7-14 over about 1-5 years. Blood samples will be taken every 3 months during the first year and every 6 months from the second year. Upon confirmed positive ctDNA, the participant will be allocated to one of four treatment arms. This can include either the control arm where participants will continue taking the same ET as previously prescribed or a medication called giredestrant, either as monotherapy (on its own) or in combination with abemaciclib or inavolisib. Apart from abemaciclib, the study drugs are not yet approved by the MHRA. In preclinical studies, giredestrant and inavolisib showed strong anti-tumour activity. Participants will receive study treatment every day from Day 1, continuously in cycles of 28 days for 2-5 years. Participants may continue to receive study drugs for a prolonged period. Once the treatment is complete, participants will have a safety follow-up visit/s. The following study procedures will be performed during the treatment phase: (a) physical examinations (b) ECGs (c) blood tests, (d) urine tests (e) CT/MRI/Bone scans (f) ultrasound (g) mammogram
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0130
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion