Personalised Disease Monitoring in Metastatic Breast Cancer (PDM-MBC)
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ClinicalTrials.gov Identifier: NCT04597580 |
Recruitment Status :
Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : August 28, 2023
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Condition or disease |
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Breast Cancer Metastatic Estrogen Receptor-positive Breast Cancer |
One hundred patients with estrogen receptor positive (ER+)/ Human epidermal growth factor receptor negative (HER2-) metastatic or locally advanced breast cancer, eligible for 1st line endocrine therapy with AI + CDK4/6i will be included. Patients will receive standard therapy (AI + CDK4/6i) and follow-up will proceed according to local guidelines, namely cross sectional imaging with CT thorax/abdomen/pelvis +/- MRI as required and analysis of CA 15-3, every 3 cycles for the first year and every 3-4 cycles thereafter. Participation in the study will include serial blood sampling for the bespoke study biomarkers. Decisions on progression will be made according to the routine imaging tests and the biomarkers will be subsequently analysed.
The investigators hypothesise that the biomarkers ctDNA, TK1 and CA15-3, alone or in combination, will accurately correlate with disease status in patients receiving AI + CDK4/6i for metastatic breast cancer such that routine imaging can be delayed until predefined levels of biomarker progression.
Primary aim: To develop a biomarker-based prediction model to be used in patients with metastatic breast cancer, receiving first line therapy with AI and CDK4/6i, that provides the physician with a recommendation whether or not a radiological examination is required, based on the likelihood that the scan will actually show progressive disease.
Secondary aims
- To define the lead time between rising biomarker and subsequent progression on imaging
- To define the clinical utility of the bespoke biomarkers for disease monitoring
- The relative value of analysing TK1 "on CDK4/6i treatment" versus "off CDK4/6i treatment" for disease monitoring
- To define the economic impact of implementation of the chosen prediction model
Study Type : | Observational |
Actual Enrollment : | 97 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Personalised Disease Monitoring During Treatment With an Aromatase Inhibitor + Cyclin Dependent Kinase (CDK) 4/6 Inhibitor as 1st Line Endocrine Therapy in Patients With ER-positive/HER2-negative Metastatic Breast Cancer |
Actual Study Start Date : | May 8, 2019 |
Estimated Primary Completion Date : | May 31, 2026 |
Estimated Study Completion Date : | January 31, 2030 |
- Change in blood levels of ctDNA, CA15-3 and TK-1 assays from baseline to disease progression [ Time Frame: 3-5 years ]ctDNA, CA15-3 and TK-1 assays will be performed at baseline, 2 weeks and at every imaging timepoint to develop a statistical algorithm to predict disease progression taht can be tested prospectively in future studies.
- Best time for TK1 analysis during CDK4/6i treatment ("on treatment" vs "off treatment") [ Time Frame: 3-5 years ]The relative value of analysing TK1 "on CDK4/6i treatment" versus "off CDK4/6i treatment" for disease monitoring
- The economic impact of implementation of the chosen prediction model [ Time Frame: 3-5 years ]Cost effectiveness analysis of the using the prediction model
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Advanced breast cancer
- ER-positive/HER2-negative
- For patients who have had a prior non-breast malignancy within the last 5 years (excluding in situ carcinoma of the cervix and basal cell carcinoma of the skin) biopsy of a metastatic site is required to confirm the diagnosis of metastatic ER+/HER2- breast cancer.
- Eligible for 1st line endocrine therapy with an aromatase inhibitor and a CDK4/6 inhibitor
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
- Age ≥ 18 years
- Life expectancy > 3 months
- Radiologically assessable disease
Exclusion Criteria:
- Known central nervous system (CNS) metastases, carcinomatous meningitis or leptomeningeal disease unless treated with radiotherapy and symptomatically stable at least 2 weeks after discontinuation of steroids
- Concurrent disease(s) or familial, sociological or geographical condition that would, in the investigator's opinion, preclude compliance with study procedures
- Any serious medical disorder that would compromise the patient's safety
- Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of Informed Consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597580
Sweden | |
Department of Oncology, Sahlgrenska University Hospital | |
Gothenburg, Sweden | |
Department of Oncology, Ryhov Hospital | |
Jönköping, Sweden | |
Department of Oncology, Kalmar Hospital | |
Kalmar, Sweden | |
Department of Oncology, Linköping University Hospital | |
Linköping, Sweden | |
Department of Oncology, Södersjukhuset | |
Stockholm, Sweden | |
United Kingdom | |
The Christie NHS Foundation Trust | |
Manchester, United Kingdom, M20 4BX | |
Wigan Infirmary, Wrightington, Wigan and Leigh NHS Foundation Trust | |
Wigan, United Kingdom |
Principal Investigator: | Dr Sacha Howell, MD, PhD | University of Manchester and The Christie NHS Foundation Trust | |
Principal Investigator: | Maria Ekholm, MD, PhD | University of Gothenburg and Region Jönköping |
Responsible Party: | The Christie NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT04597580 |
Other Study ID Numbers: |
CTFSp161 |
First Posted: | October 22, 2020 Key Record Dates |
Last Update Posted: | August 28, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasm Metastasis Precision Medicine disease monitoring |
Biomarkers, Tumor Circulating Tumor DNA Thymidine Kinase |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |