Breast CancerPhase 4REMERGENCT06274515
A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
A Phase 4 study testing Tumor Tissue and Blood Draw in people with Breast Cancer, run by Hoffmann-La Roche at 28 sites in 8 countries.
Trial summary
This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tumor Tissue and Blood Draw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 2 Apr 2024to 14 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders)
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
- Participant has started treatment with subsequent anti-cancer therapy
- Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone
- Discontinuation of treatment was due to a reason other than disease progression
Trial locations and contacts
28 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
28 sites in 8 countries
Italy7 sites, 7 recruiting
- Recruiting
RCCS - Centro di Riferimento
Aviano (PN), Friuli Venezia Giulia, 33081
- Recruiting
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna, 47014
- Recruiting
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, 20132
- Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
- Recruiting
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
- Recruiting
Azienda Ospedaliero - Universitaria di Modena Policlinico
Modena, Emilia-Romagna, 41110
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
Germany5 sites, 5 recruiting
- Recruiting
St. Elisabeth Krankenhaus Köln GmbH
Cologne, 50935
- Recruiting
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen, 45136
- Recruiting
ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
Karlsruhe, 76135
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
- Recruiting
Universitätsfrauenklinik Ulm
Ulm, 89075
Belgium4 sites, 4 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
- Recruiting
AZ KLINA
Brasschaat, 2930
- Recruiting
CHU de Liège (Sart Tilman)
Liège, 4000
- Recruiting
AZ Delta (Campus Rumbeke)
Roeselare, 8800
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
HM Sanchinarro ? CIOCC
Madrid, 28050
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
United Kingdom3 sites, 3 recruiting
- Recruiting
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
- Recruiting
Imperial College Healthcare NHS Trust
London, W6 8RF
- Recruiting
Christie Hospital NHS Trust
Manchester, M20 4BX
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 9000
- Recruiting
Sjællands Universitetshospital, Køge;Onkologisk Afdeling
Køge, Denmark > Enter Text, 4600
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, 00029
- Recruiting
Tampere University Hospital
Tampere, 33520
About this study
Official title: A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Tumor Tissue and Blood Draw
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Tissue and Blood DrawProcedure or surgery
Participants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion.
| Study group | Role | What they receive |
|---|---|---|
| Mechanisms of Acquired Resistance | Experimental | Participants with breast cancer who have a newly appearing or recurrent metastatic lesion while on anti-cancer therapy will be assigned to one of 3 cohorts. Receives: Procedure: Tumor Tissue and Blood Draw |
| Mechanisms of Primary Resistance | Experimental | Participants with breast cancer who have a progressing tumor lesion while on anti-cancer therapy will be assigned to one of 2 cohorts. Receives: Procedure: Tumor Tissue and Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Measured: At least 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Measured: At least 6 months
Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Measured: At least 6 months
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)
Measured: Less than 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3)
Measured: Less than 6 months
Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3)
Measured: Less than 6 months
Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Measured: At least 6 months
Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Measured: At least 6 months
Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1)
Measured: At least 6 months
Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1)
Measured: At least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start2 Apr 2024
- Primary completion14 Jan 2028 (estimated)
- Study completion14 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274515
- Sponsor's protocol ID
- WO44977
- Acronym
- REMERGE
- Status last verified
- Nov 2026
- First submitted
- 24 Jan 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Cohort Translational Research Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies
- ClinicalTrials.gov ID
- NCT06274515
- Acronym / sponsor ID
- REMERGE / WO44977
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 14 Jan 2028 (estimated)
- Study completion
- 14 Jan 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate mechanisms of resistance to anti-breast cancer therapies in tumor and blood samples from participants with human epidermal growth factor receptor (HER2) positive, hormone receptor (HR) positive or triple negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanisms of Acquired Resistance | Experimental | Procedure: Tumor Tissue and Blood DrawParticipants with breast cancer who have a newly appearing or recurrent metastatic lesion while on anti-cancer therapy will be assigned to one of 3 cohorts. |
| Mechanisms of Primary Resistance | Experimental | Procedure: Tumor Tissue and Blood DrawParticipants with breast cancer who have a progressing tumor lesion while on anti-cancer therapy will be assigned to one of 2 cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Any risks factors that increase the risk of complications associated with the procedure to obtain tumor tissue (e.g. bleeding disorders)
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
- Participant has started treatment with subsequent anti-cancer therapy
- Participants whose progressive tumor lesion that is targeted for biopsy/resection is in the bone
- Discontinuation of treatment was due to a reason other than disease progression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Tissue and Blood DrawParticipants will have their blood drawn on the day a tissue sample is taken from a progressive tumor lesion. | Procedure or surgery | Mechanisms of Acquired Resistance, Mechanisms of Primary Resistance |
Primary outcome
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Time frame: At least 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Time frame: At least 6 months
Changes from baseline in estrogen receptor (ER) protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2)
Time frame: At least 6 months
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in HER2 gene copy number measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in ER protein levels measured at the time of disease progression/recurrence (Cohort H3)
Time frame: Less than 6 months
Changes from baseline in genes related to CDK4/6 resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Time frame: At least 6 months
Changes from baseline in genes related to endocrine resistance (incl. cell cycle alterations and tyrosine kinase receptors, Cohort R1)
Time frame: At least 6 months
Changes from baseline in tumor immune microenvironment (PD-L1 and TILs, Cohort T1)
Time frame: At least 6 months
Changes from baseline in immune phenotype (PD-L1 and TILs, Cohort T1)
Time frame: At least 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
28 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tumor Tissue and Blood Draw in people with Breast Cancer, run by Hoffmann-La Roche at 28 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Germany, Belgium, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: WO44977 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in HER2 protein levels measured at the time of disease progression/recurrence (Cohorts H1 and H2) (time frame: At least 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.