Metastatic Breast CancerPhase 2HEROESNCT06450314
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
A Phase 2 study testing Discontinuation of the anti-HER2 maintenance therapy and Monitoring with signatera test in people with Metastatic Breast Cancer and HER2-positive Breast Cancer, run by UNICANCER at 1 site in France.
Trial summary
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Discontinuation of the anti-HER2 maintenance therapy and Monitoring with signatera test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2025to 15 Dec 2029
- Phase
- Phase 2
- 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
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;
- Men or women ≥18 years of age;
- Documented diagnosis of locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer (HER2-positive is defined as HER2 3+ immunohistochemical overexpression, or the presence of HER2 amplification, according to ASCO-CAP guidelines);
- Must have an adequate archival tumor tissue sample available for next-generation sequencing (NGS) analysis by central laboratory, in order to design the ctDNA test (based on most recent available tumor tissue sample, metastatic biopsy (bone tissue excluded) and primary tumor authorised);
- Patient with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) ≤1;
- Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan or T-DM1) treatment for at least 2 years in any line setting, for their locally advanced inoperable or metastatic HER2 + breast cancer (prior treatment interruption of 3 months maximum is allowed), with complete response or partial response at last radiological assessment;
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- Note: the number of patients who received anti-HER2 targeted therapy in second line setting or more will be capped to 50% of the overall population
- In case of bone disease only, complete metabolic response in 18-FDG pet-scanner is required;
- Patient with treated (surgery and/or radiation therapy) and controlled primary tumor;
- Patients with ER-positive disease may or may not have received concomitant endocrine therapy (which must be continued if present). Concomitant ovarian blockade using Luteinizing Hormone-Releasing Hormone (LHRH) agonists is authorised as well;
- Adequate cardiac, renal, haematological and hepatic functions according to guidelines hospital;
- Women of childbearing potential must have a negative serum or urine pregnancy test done within 28 days before inclusion;
- Non post-menopausal women and fertile men must agree to use adequate contraception methods during the study. Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive;
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan and other study procedures including follow-up;
- Patients must be affiliated to a Social Security System (or equivalent).
Who cannot join
- Any breast cancer progression over the past 2 years or at study entry;
- Patient concurrently using other approved or investigational antineoplastic agents than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, TDM-1 +/- endocrine therapy;
- Had an history of tumoral meningitis or clinically active central nervous system metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
- Subjects with curatively treated brain metastases (i.e., complete removal surgery or stereotactic radiotherapy) who are no longer symptomatic and do not require treatment with corticosteroids or anticonvulsants may be included in the study provided they have recovered from the acute toxicity of radiotherapy and there has been no progression of the brain metastases within the past 24 months.
- Subjects with brain metastases only or treated with whole brain radiotherapy will be excluded of the study
- Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
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- History of any prior ipsi or contralateral breast cancer (except in case of DCIS) unless if both primary tumors were confirmed to be HER2-positive;
- Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease and treatment for at least 3 years;
- Major surgery within 2 weeks prior to study entry;
- Pregnant women or women who are breast-feeding;
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons;
- Participation in another clinical study whose procedures interfere with those of the study (within 28 days prior to patient enrolment and for the duration of the study);
- Persons deprived of their liberty or under protective custody or guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thibault De la Motte Rouge, MD contact
France1 site, 1 recruiting
- Recruiting
Centre Eugène marquis
Rennes, 44229
Thibault De la motte rouge, Md
About this study
Official title: De-escalation of Medical Therapies in HER2-positive Metastatic Breast Cancer in Long-term Persistent Response and Minimal Residual Disease Undetectable in Circulating Tumor DNA
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing.
The main question it aims to answer is :
- Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?
Read the detailed description
Metastatic breast cancer remains a difficult disease to cure in the majority of cases. Improved biological knowledge has made it possible to separate these heterogeneous pathologies into several subtypes. For the HER2 subtype, which accounts for around 15% of breast cancers, very significant progress has been made in recent years with innovative treatments known as anti-HER2 therapies (trastuzumab, pertuzumab, T-DM1, T-DXd). Long-term disease control has been achieved in at least 20% of these patients with these new treatments.
However, the treatments are continued indefinitely, impacting patients' quality of life through toxicity and chronic administration. It is possible that, for some patients, these treatments can be discontinued while maintaining surveillance. To assess this possibility, new biological tools, notably the search for circulating tumor DNA (ctDNA), look very promising for detecting any tumor cells in the body, even to very small traces (minimal residual disease).
The primary objective of this trial is to evaluate the feasibility of therapeutic de-escalation (temporary or complete discontinuation) in patients with HER2-positive metastatic breast cancer whose disease is controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND a negative ctDNA test.
- Being tested
- Discontinuation of the anti-HER2 maintenance therapy, Monitoring with signatera test
- Keywords
- de-escalation, ctDNA test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of the anti-HER2 maintenance therapyDrug
Heroes is a de-escalation study. Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line setting for their HER2-positive metastatic breast cancer with complete response or partial response at last radiological assessment. Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study
Monitoring with signatera testDevice
ctDNA test will be performed at 1.5 month after inclusion and every 3 months during 2 years.
Note: For the ctDNA negative patients who become ctDNA positive: ctDNA test will be performed once, 3 months after restarting treatment (+/-1 week).
| Study group | Role | What they receive |
|---|---|---|
| ctDNA negative cohort at baseline | Experimental | Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study
* In case of radiological progression with or without ctDNA positive test, prior treatment will be restarted or new anti-HER2 treatment will be initiated according investigator choice
* In case of ctDNA positive test without radiological progression, prior treatment will be restarted. Receives: Drug: Discontinuation of the anti-HER2 maintenance therapy; Device: Monitoring with signatera test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free rate
The progression-free rate (PFR) is the percentage of patient with disease progression defined as the time from the date of registration to the date of the first documented event among radiological progressions (RECIST 1.1), molecular progressions definitive as ctDNA-positive results, or death due to any cause, whichever occurs first.
Measured: 1 year
Secondary outcomes (11)
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of registration to the date of the first documented cancer progression measured by RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: 1 year
ctDNA dynamics
The ctDNA dynamics is defined as changes in the level of ctDNA (from negative to positive) during the surveillance phase.
Measured: 1 year
ctDNA positivity rate
Positivity rate is defined as the proportion of patients with positive ctDNA results.
Measured: 1 year
Overall Survival
Overall Survival (OS) is defined as the time from the date of registration to the date of death due to any cause
Measured: 1 year
Molecular response
Molecular response is defined as the percentage of patients who reached molecular remission (ctDNA clearance) 3 months after reintroduction of anti-HER2 treatment among patients with ctDNA positive without RECIST progression.
Measured: 1 year
Objective Response Rate
Objective Response Rate (ORR) is defined as the number of patients with at least a confirmed complete response (CR) or partial response (PR) to reintroduction of anti-HER2 treatment, among patients with RECIST progression during the surveillance phase
Measured: 1 year
Duration of Response
The duration of response (Dor) is defined, among patients with RECIST progression during the surveillance phase, as the time from the onset of response after reintroduction of anti-HER2 treatment, to progression or death due to any cause, whichever occurs first.
Measured: 1 year
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline then every 3 months during 2 years and every 6 months the third year
Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems.
Measured: At baseline then every 3 months during 2 years and every 6 months the third year
State-Trait Anxiety Inventory - state (STAI-S)
The State-Trait Anxiety Inventory - state (STAI-S) is a commonly used measure of state anxiety.
This 20-item questionnaire measures the intensity of the participant's anxiety at the moment of testing. The items are designed to measure an individual's feelings oftension, apprehension, nervousness, and worry. All items are rated on a 4-point scale (1 = "not at all", 2 = "somewhat", 3 = "moderately", and 4 = "very much"). Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Measured: At 6 months and 1 year
Decision regret scale (DRS)
The decision regret was developed to measure regret after health-care decisions.
This questionnaire incorparate 5 items about decision regret, decision correctness, belief in making the same decision again, wisdom and any resulting harm from the decision. All items are rated on a 5-point Likert-type scale (1 = "strongly agree", 2 = "agree", 3 = "neither agree or disagree", 4 = "disagree", and 5 = "strongly disagree"), and are transformed to a 0-100 scale. Higher scores indicate more regret.
Measured: At 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start25 Jan 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc.
- Responsible party
- Sponsor
- Investigators
- Thibault De la Motte Rouge, MD, Principal investigator, Centre Eugene Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450314
- Sponsor's protocol ID
- UC-BCG-2312
- Other IDs
- 2023-509811-98-00, 2023
- Acronym
- HEROES
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Medical Therapies in HER2-positive Metastatic Breast Cancer in Long-term Persistent Response and Minimal Residual Disease Undetectable in Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT06450314
- Acronym / sponsor ID
- HEROES / UC-BCG-2312
- Keywords
- de-escalation, ctDNA test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Natera, Inc.
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 10 Jun 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.
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing.
The main question it aims to answer is :
- Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?
Detailed description
Metastatic breast cancer remains a difficult disease to cure in the majority of cases. Improved biological knowledge has made it possible to separate these heterogeneous pathologies into several subtypes. For the HER2 subtype, which accounts for around 15% of breast cancers, very significant progress has been made in recent years with innovative treatments known as anti-HER2 therapies (trastuzumab, pertuzumab, T-DM1, T-DXd). Long-term disease control has been achieved in at least 20% of these patients with these new treatments.
However, the treatments are continued indefinitely, impacting patients' quality of life through toxicity and chronic administration. It is possible that, for some patients, these treatments can be discontinued while maintaining surveillance. To assess this possibility, new biological tools, notably the search for circulating tumor DNA (ctDNA), look very promising for detecting any tumor cells in the body, even to very small traces (minimal residual disease).
The primary objective of this trial is to evaluate the feasibility of therapeutic de-escalation (temporary or complete discontinuation) in patients with HER2-positive metastatic breast cancer whose disease is controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND a negative ctDNA test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA negative cohort at baseline | Experimental | Drug: Discontinuation of the anti-HER2 maintenance therapy, Device: Monitoring with signatera testPatients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study * In case of radiological progression with or without ctDNA positive test, prior treatment will be restarted or new anti-HER2 treatment will be initiated according investigator choice * In case of ctDNA positive test without radiological progression, prior treatment will be restarted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;
- Men or women ≥18 years of age;
- Documented diagnosis of locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer (HER2-positive is defined as HER2 3+ immunohistochemical overexpression, or the presence of HER2 amplification, according to ASCO-CAP guidelines);
- Must have an adequate archival tumor tissue sample available for next-generation sequencing (NGS) analysis by central laboratory, in order to design the ctDNA test (based on most recent available tumor tissue sample, metastatic biopsy (bone tissue excluded) and primary tumor authorised);
- Patient with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) ≤1;
Key exclusion criteria (13 listed)
- Any breast cancer progression over the past 2 years or at study entry;
- Patient concurrently using other approved or investigational antineoplastic agents than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, TDM-1 +/- endocrine therapy;
- Had an history of tumoral meningitis or clinically active central nervous system metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;
- Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;
- History of any prior ipsi or contralateral breast cancer (except in case of DCIS) unless if both primary tumors were confirmed to be HER2-positive;
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 |
|---|---|---|
| Discontinuation of the anti-HER2 maintenance therapyHeroes is a de-escalation study. Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line setting for their HER2-positive metastatic breast cancer with complete response or partial response at last radiological assessment. Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study | Drug | ctDNA negative cohort at baseline |
| Monitoring with signatera testctDNA test will be performed at 1.5 month after inclusion and every 3 months during 2 years. Note: For the ctDNA negative patients who become ctDNA positive: ctDNA test will be performed once, 3 months after restarting treatment (+/-1 week). | Device | ctDNA negative cohort at baseline |
Primary outcome
Progression-free rate
Time frame: 1 year
The progression-free rate (PFR) is the percentage of patient with disease progression defined as the time from the date of registration to the date of the first documented event among radiological progressions (RECIST 1.1), molecular progressions definitive as ctDNA-positive results, or death due to any cause, whichever occurs first.
11 secondary outcomes
Progression-free survival
Time frame: 1 year
ctDNA dynamics
Time frame: 1 year
ctDNA positivity rate
Time frame: 1 year
Overall Survival
Time frame: 1 year
Molecular response
Time frame: 1 year
Objective Response Rate
Time frame: 1 year
Duration of Response
Time frame: 1 year
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline then every 3 months during 2 years and every 6 months the third year
Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)
Time frame: At baseline then every 3 months during 2 years and every 6 months the third year
State-Trait Anxiety Inventory - state (STAI-S)
Time frame: At 6 months and 1 year
Decision regret scale (DRS)
Time frame: At 6 months and 1 year
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 21 Jul 2026.
- 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.
Thibault De la Motte Rouge, MD contact
Thibault De la Motte Rouge, MD principal investigator
Centre Eugene Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Discontinuation of the anti-HER2 maintenance therapy and Monitoring with signatera test in people with Metastatic Breast Cancer and HER2-positive Breast Cancer, run by UNICANCER at 1 site in France.
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 15 inclusion and 13 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Clara Guyonneau, PharmD (+33 (0) 1 44.23.04.65, c-guyonneau@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free rate (time frame: 1 year). 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 21 Jul 2026.