Blood tests may spare breast cancer patients from unnecessary scans
NCT ID NCT04597580
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether simple blood tests can tell if a woman's metastatic breast cancer is stable, so she can skip some routine scans. About 97 women with ER-positive/HER2-negative cancer will give blood samples at each scan visit. The goal is to create a smart algorithm that uses these blood markers to safely decide when imaging is not needed.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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97 people
The number who actually took part.
- Started
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May 2019
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with ER+/HER2- metastatic or locally advanced breast cancer, not amendable for curative surgery, eligible for 1st line endocrine therapy with aromatase inhibitor (AI) + CDK4/6-inhibitor (CDK4/6i).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed metastatic breast cancer (stage 4) or locally advanced disease not amendable to curative resection. Patients who have locoregional disease only an in whom a response to therapy would lead to potentially curative resection are not eligible. * ER+/HER2- breast cancer (assessed locally). NOTE: If immunohistochemical analysis is not available from metastatic tissue, the ER and HER2 status from the primary tumour should be used. * 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 treatment with AI + CDK4/6-inhibitor according to local guidelines. NOTE: ≥ 12 month since termination of adjuvant AI if used NOTE: Patients may have received one prior line of chemotherapy for metastatic breast cancer but should have disease progression at study entry. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 (Oken 1982). * Life expectancy \>3 months. * Age ≥ 18 years * Metastatic disease must be radiologically assessable, by means of at least one of the following techniques: computerised tomography (CT) and/or magnetic resonance imaging (MRI), i.e. lesions can be measurable or non-measurable according to RECIST 1.1, but must be clearly evaluable according to the radiologist and/or treating physician. Patients with bone predominant disease who lack evaluable disease on CT according to RECIST 1.1. must have serial MRI including the representative area in addition to CT TAP. NOTE: Previously irradiated lesions are deemed measurable only if progression is documented at the site after completion of radiation. \- Willing and able to provide informed consent to undergo all trial procedures. Exclusion Criteria: * Known CNS metastases, carcinomatous meningitis or leptomeningeal disease unless treated with radiotherapy and symptomatically stable at least 2 weeks after discontinuation of steroids. For such patients, ongoing monitoring of CNS disease is required as standard of care. No screening is needed for asymptomatic patients. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Oncology, Kalmar Hospital
Kalmar, Sweden
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Department of Oncology, Linköping University Hospital
Linköping, Sweden
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Department of Oncology, Ryhov Hospital
Jönköping, Sweden
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Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
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Department of Oncology, Södersjukhuset
Stockholm, Sweden
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The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
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Wigan Infirmary, Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, United Kingdom
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Other studies related to the condition(s) this trial covers.
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