Actively Recruiting
Randomised Trial of Early Molecular Relapse Detection Using Circulating Tumour DNA and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in ER Positive HER2 Negative Breast Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2024-12-05
1100
Participants Needed
49
Research Sites
156 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of circulating tumour DNA ctDNA analysis to detect early molecular relapse in patients with estrogen receptor positive ER and HER2 negative breast cancer who are undergoing adjuvant endocrine therapy. This trial aims to determine if treatment with palbociclib plus fulvestrant can delay or prevent relapse in patients who show positive ctDNA results. The study is a Phase 2, multi-centre, randomized, open-label trial focusing on high-risk patients with early-stage breast cancer. The trial has two main phases a surveillance phase and a treatment phase. During the surveillance phase, patients receive ctDNA testing every three months for up to three years to monitor for molecular relapse. If ctDNA is detected without visible disease on imaging, patients enter the treatment phase, where they are randomly assigned to receive either standard endocrine therapy or a combination of palbociclib and fulvestrant for up to 24 months. Palbociclib is taken orally daily for 21 days of each 28-day cycle, while fulvestrant is given as intramuscular injections on specific days of each cycle. Imaging is performed every six months to check for overt disease. Participants undergo regular blood tests for ctDNA monitoring during the surveillance phase and receive clinical assessments, imaging scans, and quality of life questionnaires during the treatment phase. Researchers measure the incidence of positive ctDNA results, relapse-free survival, and monitor adverse events. The total follow-up for relapse-free survival extends up to 60 months from randomization, while safety and quality of life are assessed up to 24 months. If macroscopic disease appears, participants stop trial treatment and receive standard care outside the study.
CONDITIONS
Brief Title
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the trial and sample donation
- Male or female patients aged 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed primary ER positive (Allred score 6/8 or greater or 10% cancer cells) and HER2 negative breast cancer
- High-risk early stage breast cancer based on lymph node involvement, tumour size, histological grade, or genomic risk scores
- Available archival tumour tissue sample
- No evidence of visible distant metastatic or incurable locally advanced disease on imaging
- Receiving standard endocrine therapy for at least 6 months and up to 7 years, with at least 3 more years planned
- Surgery with clear margins completed
- Willing to use adequate contraception if of reproductive potential during treatment and follow-up
- Willing to have frequent blood tests
- Signed informed consent for treatment phase
- Women of childbearing potential must have a negative pregnancy test before randomisation
- Adequate bone marrow and organ function by laboratory tests
- Post-menopausal or pre/peri-menopausal with ovarian suppression if receiving palbociclib plus fulvestrant
You will not qualify if you...
- Receiving or planning treatments other than endocrine therapy or bisphosphonates for breast cancer
- Prior CDK4/6 inhibitor treatment within the past 12 months
- Previous therapeutic dose of fulvestrant
- Other cancer diagnosis within past 5 years except certain skin or cervical cancers
- Participation in therapeutic trials with continued experimental therapy post-surgery
- Treatment with experimental products within 4 weeks prior to trial
- Unresolved side effects from prior cancer therapies beyond grade 1 (except alopecia)
- Significant gastrointestinal conditions affecting oral medication absorption
- Severe uncontrolled medical conditions or safety risks per investigator
- Uncontrolled heart disease including recent heart attack, heart failure, arrhythmia, or long QT syndrome
- History of pneumonitis, interstitial lung disease, or pulmonary fibrosis
- Known HIV or active Hepatitis B or C infection
- Pregnancy or breastfeeding
- History of bleeding disorders or anticoagulant treatments (except some allowed medications)
- Severe liver or kidney impairment
- Bilateral or multifocal tumours not deemed a single primary cancer
- Hypersensitivity to palbociclib plus fulvestrant components
- Major surgery within 4 weeks before treatment or incomplete recovery
- Current use of warfarin or similar anticoagulants
- Use of medications or supplements affecting CYP3A4 that cannot be stopped before treatment
- History of non-compliance with medical regimens
Research Team
P
Project Manager
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