Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
janvier 2025
décembre 2029
04 septembre 2025
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?
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | NGUEFACK Rolande | 18/09/2025 17:50:07 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène marquis - 44229 - Rennes - France | Thibault De la motte rouge, Md | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. 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;
2. Men or women ≥18 years of age;
3. 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);
4. 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);
5. Patient with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) ≤1;
6. 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;
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
7. In case of bone disease only, complete metabolic response in 18-FDG pet-scanner is
required;
8. Patient with treated (surgery and/or radiation therapy) and controlled primary
tumor;
9. 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;
10. Adequate cardiac, renal, haematological and hepatic functions according to
guidelines hospital;
11. Women of childbearing potential must have a negative serum or urine pregnancy test
done within 28 days before inclusion;
12. 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;
13. 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;
14. Patients must be affiliated to a Social Security System (or equivalent).
1. 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;
2. Men or women ≥18 years of age;
3. 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);
4. 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);
5. Patient with Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) ≤1;
6. 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;
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
7. In case of bone disease only, complete metabolic response in 18-FDG pet-scanner is
required;
8. Patient with treated (surgery and/or radiation therapy) and controlled primary
tumor;
9. 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;
10. Adequate cardiac, renal, haematological and hepatic functions according to
guidelines hospital;
11. Women of childbearing potential must have a negative serum or urine pregnancy test
done within 28 days before inclusion;
12. 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;
13. 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;
14. Patients must be affiliated to a Social Security System (or equivalent).
1. Any breast cancer progression over the past 2 years or at study entry;
2. Patient concurrently using other approved or investigational antineoplastic agents
than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, TDM-1 +/- endocrine therapy;
3. 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;
1. 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.
2. Subjects with brain metastases only or treated with whole brain radiotherapy
will be excluded of the study
4. 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;
5. 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;
6. 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;
7. Major surgery within 2 weeks prior to study entry;
8. Pregnant women or women who are breast-feeding;
9. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons;
10. 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);
11. Persons deprived of their liberty or under protective custody or guardianship.