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Blood test maps hidden resistance signal in advanced breast cancer

NCT ID NCT07817212

Diagnosis Sponsor: Institut fuer Frauengesundheit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

People with hormone receptor-positive, HER2-negative advanced breast cancer often start treatment with a CDK4/6 inhibitor plus an aromatase inhibitor. Over time, some tumors develop an ESR1 mutation that can make the aromatase inhibitor stop working. This study takes blood samples from about 1,550 patients at different points during first-line treatment to measure how often that mutation appears. Researchers want to learn whether a single blood test at a chosen time could guide when to check for resistance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a blood test for ESR1 mutations
What this could lead to
If the testing strategy proves practical, doctors could use a simple blood draw to spot aromatase inhibitor resistance earlier and switch some patients to a different hormone therapy sooner.
What could go wrong
This study only measures how common ESR1 mutations are at different treatment timepoints. It does not test whether acting on those results improves outcomes, so any change to treatment would still need separate trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,550 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must be female or male and aged ≥ 18 years on the day of signing informed consent 2. Patient has locally advanced or metastatic breast cancer not amenable to curative treatment 3. Patient has HER2- breast cancer confirmed by local laboratory, defined as a negative in situ hybridization test or an IHC status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory) 4. Histologically confirmed ER-positive and/ or PgR-positive breast cancer determined by core biopsy according to local in-house standard 5. Patient has already initiated or is about to initiate first-line therapy with a CDK4/6 inhibitor (any CDK4/6i) in combination with an aromatase inhibitor (non-steroidal AI). Treatment must be intended as first-line systemic therapy for advanced or metastatic disease 6. Information about prior oncological therapies against the HR+/HER2- BC must be available 7. Data about histo-pathological report must be available, including hormone receptor status, tumor histology, tumor grading and HER2 immunohistochemistry 8. Inclusion in the study occurs as a single, one-time event for each patient, within one of the 9 defined cohorts Exclusion Criteria: 1. Patients with an interruption of ongoing first-line CDK4/6i plus AI therapy exceeding 1 month for either CDK4/6i or AI 2. Patients receiving any other systemic anticancer therapy for HR+/HER2- aBC, except for LHRH agonists, bisphosphonates, or denosumab 3. Clinical evidence of progression at the timepoint of study inclusion 4. Patients have already completed ≥ 1L of systemic therapy for aBC

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HR+/HER2- abc undergoing 1L treatment with CDK4/6I (palbociclib, abemaciclib or ribociclib) and ai (anastrozole or letrozole)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ANregiomed gKU, AöR, Klinikum Ansbach

    Ansbach, 91522, Germany

  • Allgemeines Krankenhaus Celle; Brustzentrum

    Celle, 29223, Germany

  • Frauenarztpraxis Baerens

    Ilsede, 31241, Germany

  • Frauenärzte am Schloß; Praxis für Gynäkologie und Geburtshilfe

    Wolfenbüttel, 38304, Germany

  • Helios Dr. Horst Schmidt Kliniken; Gynäkologie

    Wiesbaden, 65199, Germany

  • Hämato-Onkologische Praxis im Medicum; Brustzentrum

    Bremen, Germany

  • Hämatologie OnkologieMünchen Pasing MVZ GmbH

    München, 81241, Germany

  • Klinikum Ernst von Bergmann; Frauenheilkunde

    Potsdam, 14467, Germany

  • Kostara Gyn. Onkoloy Clinic Research UG

    Düsseldorf, 40235, Germany

  • Kreiskrankenhaus Torgau; Brustzentrum

    Torgau, 04860, Germany

  • MVZ Media Vita am St. Franziskus Hospital; Frauenklinik

    Münster, 48145, Germany

  • Medizinische Studiengesellschaft Nord-West GmbH; Onkologie

    Westerstede, 26655, Germany

  • OncoStudies Lörrach, Onkologie Dreiländereck

    Loerrach, 79539, Germany

  • Rotkreuzklinikum München; Brustzentrum

    München, 80637, Germany

  • Universitätsklinik Würzburg; Frauenklinik und Poliklinik

    Würzburg, 97080, Germany

  • Universitätsklinikum Carl Gustav Carus Dresden, Frauenklinik

    Dresden, 01307, Germany

  • Universitätsklinikum Erlangen, Frauenklinik

    Erlangen, 91054, Germany

  • Universitätsklinikum Münster; Frauenklinik

    Münster, 48727, Germany

  • Universitätsklinikum Tübingen; Department für Frauengesundheit

    Tübingen, 72076, Germany

  • Universitätsklinikum; Frauenheilkunde, Geburtshilfe & Reproduktionsmedizin

    Homburg, 66421, Germany

  • medicum Rosenheim MVZ GmbH; Innere Onkologie

    Rosenheim, 83022, Germany