Informations générales (source: ClinicalTrials.gov)
A ctDNA Screening Program in Patients With HR+, HER2 Low Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor Followed by a Single Arm Phase II Trial of Trastuzumab-deruxtecan in Patients With Persistent ctDNA After 1 Month of Treatment With Endocrine Therapy Combined With CDK4/6 Inhibitor
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
juillet 2025
août 2029
10 juin 2026
After an initial screening phase to identify patients with persistent blood circulating
DNA tumors, patients will be enrolled in the treatment phase that was designed as an
open-label, multicentre, phase II study, to test the efficacy of trastuzumab deruxtecan
in terms of progression-free survival (PFS).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Joana Mourato RIBEIRO | 29/05/2026 17:55:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugene Marquis - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Beauvais - 60021 - Beauvais - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Chp Saint-Grégoire - Groupe Vivalto Sante - 35760 - Saint-Grégoire - France | Contact (sur clinicalTrials) | ||||
| Chu Amiens Picardie - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Chu de Brest - Hôpital Cavale Blanche - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Clinique Sainte-Anne - Gh Saint-Vincent - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôpitaux Du Léman - 74200 - Thonon-les-Bains - France | Contact (sur clinicalTrials) | ||||
| Pôle Santé République (Elsan) - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| 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 Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Alpes Léman - 74130 - Contamine-sur-Arve - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier D'Auxerre - 89000 - Auxerre - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Cholet - 49300 - Cholet - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Pau - 64046 - Pau - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier William Morey - 71100 - Chalon-sur-Saône - France | Contact (sur clinicalTrials) | ||||
| Chd Vendée - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| Chi Fréjus-Saint-Raphaël - 83608 - Fréjus - France | Contact (sur clinicalTrials) | ||||
| Clinique de La Sauvegarde - 69009 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Clinique de L'Europe Amiens - Cthe - 80090 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
| Hopital Privé Des Côtes D'Armor (Hpca) - Cario - 22190 - Plérin - France | Contact (sur clinicalTrials) | ||||
| Hopital Prive Jean Mermoz - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint-Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hôpital Simone Veil de Blois - 41000 - Blois - France | Contact (sur clinicalTrials) | ||||
| Icm Val D'Aurelle - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - 054519 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Godinot - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly) - 54100 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Sainte Catherine Institut Du Cancer Avignon Provence - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
SCREENING PHASE_________________________________________________________
Inclusion criteria
1. Patient must have signed the written informed consent for screening phase prior to
any trial specific procedures.
Note: 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 writing the patient's consent.
2. Patient is ≥18 years of age.
3. Documented breast cancer that:
- Is metastatic and eligible to biopsy for subsequent histological or cytological
confirmation,
- Is HER2 low (HER2 1+, or 2+ and in situ hybridization (ISH) negative) or HER2
ultra low (IHC 0 with incomplete and faint membrane staining in >0 and ≤10% of
tumor cells) on the most recent tumor material available, as defined by the
local pathologist under ASCO/CAP guidelines,
- Is HR-positive (positive for estrogen receptor or progesterone receptor ≥10% of
tumor cell nuclei are immunoreactive) in the metastatic setting.
4. Patient has either:
- a metastatic relapse during or within 1 year after termination of the adjuvant
endocrine therapy (AI resistant), or
- a metastatic relapse more than one year of completing adjuvant AI or a de-novo
metastatic breast cancer (AI sensitive/naive).
5. For AI resistant population: patient has previously gone through the ctDNA screening
part of the SAFIR 03 - SCREENING/ARRIBA study and fulfilled all the inclusion
criteria and none of the exclusion criteria.
6. Patient did not receive any therapy in the metastatic setting.
7. Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor
(palbociclib, ribociclib, or abemaciclib) in combination with either AI or
fulvestrant, according to its marketing authorisation.
8. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
9. Patient has an adequate bone marrow and organ function.
10. Patient has a measurable or an evaluable disease according to Response Evaluation
Criteria In Solid Tumours version 1.1 (RECIST v1.1).
11. Availability of an archived metastatic tumor sample (FFPE) for exploratory research.
Bone metastasis are accepted if tissue is representative of tumor tissue (at least
10% tumor cellularity).
12. Patient must be willing and able to comply with the protocol for the duration of the
study including scheduled visits, treatment plan, laboratory tests and other study
procedures.
13. Registration in a National Health Care System (or equivalent).
Exclusion criteria:
1. Patient is eligible to chemotherapy because of visceral crisis.
2. Patient has a breast cancer amenable for resection or radiation therapy with
curative intent.
3. Prior exposure to antibody-drug conjugate or CDK4/6 inhibitors (in metastatic
setting). CDK4/6 inhibitors given in adjuvant setting must be stopped for at least
12 months prior screening
4. Patient who has initiated the CDK4/6 inhibitor treatment.
5. Patient is unable to swallow tablets.
6. Patient has a history of (non-infectious) interstitial lung disease
(ILD)/pneumonitis requiring steroids, has current ILD/pneumonitis, or where
suspected ILD/pneumonitis cannot be ruled out by imaging at baseline
7. Patient has a history of severe hypersensitivity reactions to either the drug
substances or inactive ingredients in the drug product.
8. Patient has a history of severe hypersensitivity reactions to other monoclonal
antibodies.
9. Person deprived of their liberty or under protective custody or guardianship.
10. Social, familial, or geographic factors that would interfere with study
participation or follow-up.
TREATMENT PHASE_________________________________________________________
Inclusion criteria
1. Patient must have signed the written informed consent for the treatment phase prior
to any trial specific procedures.
Note: 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 writing the patient's consent.
2. Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or
abemaciclib) at least 7 days before enrolment, but no longer than 14 days
3. Patients must present a no drop of ctDNA determined by a ctDNA assay after 4 weeks
of standard of care treatment with a CDK4/6 inhibitor
4. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
5. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to enrolment.
6. Participant has adequate bone marrow and organ function within 14 days before
enrolment, defined as the following laboratory values:
- Absolute neutrophil count (ANC) ≥1500/mm³,
- platelet count ≥100,000/mm³,
- haemoglobin ≥9.0 g/dl,
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥30
mL/min,
- Serum albumin ≥2.5 g/dL,
- Total bilirubin ≤1.5 × ULN (<3 ULN if Gilbert's disease),
- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤3 × ULN. If the participant has liver metastases, ALT
and AST < 5 × ULN, he/she will be eligible for the study,
- Adequate blood clotting function: defined as an international normalized
ratio/prothrombin time ≤1.5 × ULN and either partial thromboplastin time or
activated partial thromboplastin time within normal limits.
Note: Transfusion (red blood cell or platelet) or G-CSF administration is not
allowed within 14 days prior to the day on which bone marrow function is assessed,
or at any time after this day and prior to cycle 1 day 1.
7. Women of childbearing potential must have a negative serum pregnancy test (with a
sensitivity of at least 25 mIU/mL) result within 3 days of enrolment.
8. Men or women of childbearing potential must agree to the use of effective
contraceptive for the study duration and for at least 7 months after the last dose
of study treatment for women, and at least 4 months for men.
9. Patient must be willing and able to comply with the protocol for the duration of the
study including scheduled visits, treatment plan, laboratory tests and other study
procedures.
Exclusion criteria:
1. AI resistant patients who are eligible to SAFIR 03 - ARRIBA trial (i.e. PIK3CA
mutated patients), until SAFIR 03 - ARRIBA study closure or study steering
committee's decision.
2. Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment
combined with either AI or fulvestrant.
3. Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14
days.
4. Patient has evidence of clinical or radiological disease progression.
5. Patient has unresolved toxicities from previous anticancer therapy, defined as
toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
Note: Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as
no worsening to >Grade 2 for at least 3 months prior to enrolment and managed with
standard of care treatment) that the investigator deems related to previous
anticancer therapy, such as: Chemotherapy-induced neuropathy and fatigue.
6. Patient has malignancies within 3 years, other than that under study, with the
exception of: adequately resected non-melanoma skin cancer, curatively treated
in-situ disease, other solid tumors curatively treated, or contralateral breast
cancer.
7. Patient is at high medical risk because of severe or uncontrolled systemic disease,
such as uncontrolled diabetes mellitus, clinically significant pulmonary disease,
clinically significant neurological disorder, chronic pancreatitis, chronic active
infection with hepatitis B virus, hepatitis C virus, or HIV, active untreated or
uncontrolled fungal, bacterial or viral infections, active primary immunodeficiency
etc.
8. Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment,
- History of symptomatic congestive heart failure (New York Heart Association
Class II to IV),
- Patient with a corrected QT interval (QTc) prolongation to >470 ms (females) or
>450 ms (males) based on average of the screening triplicate12-lead ECG,
- Patients with known troponin levels above ULN at screening (as defined by the
manufacturer), and without any myocardial related symptoms, should have a
cardiologic consultation before enrolment to rule out myocardial infarction.
9. Clinically severe pulmonary compromise resulting from current pulmonary illnesses
including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary
emboli within three months of the study enrolment, severe asthma, severe chronic
obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion,
etc.), and any autoimmune, connective tissue, or inflammatory disorders with
pulmonary involvement (i.e., rheumatoid arthritis, Sjögren's, sarcoidosis, etc.), or
prior pneumonectomy.
10. Patient has spinal cord compression or clinically active central nervous system
metastases, defined as untreated or symptomatic, or requiring therapy with
corticosteroids or anticonvulsants to control associated symptoms.
11. Major surgery within 4 weeks before study enrolment.
12. Patient who has received radiotherapy ≤4 weeks or limited field radiation for
palliation ≤2 weeks prior to enrolment, or who has not recovered to grade 1 or
better from related side effects of such therapy (exceptions include alopecia)
and/or in whom ≥25% of the bone marrow was irradiated
13. Patient using drugs that could have pharmacokinetics interaction with
investigational drugs. Concomitant use of strong CYP3A4 inhibitors or OATP 1B
inhibitors should be avoided. If concomitant use of strong CYP3A4 or OATP 1B
inhibitors is unavoidable, consider delaying T-DXd treatment until the inhibitors
have cleared from the circulation (approximately 3 elimination half-lives of the
inhibitors) when possible. If a strong CYP3A4 inhibitor or an OATP 1B inhibitor is
co-administered and T-DXd treatment cannot be delayed, patients should be closely
monitored for adverse reactions.
14. Patient receiving drug that may cause QTc prolongations or cardiac arrhythmia.
Pimozide (Orap®) and cisapride (Prepulsid®) are strictly contraindicated: they are
associated with a major risk of ventricular rhythm disorder.
15. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral
vaccines are not considered attenuated live vaccines) within 30 days prior to the
first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not
receive live vaccine during the study and up to 30 days after the last dose of
T-DXd.
16. Participation in a therapeutic clinical study within 4 weeks before enrolment.
17. Patient is currently pregnant, breastfeeding, or planning to become pregnant
18. Patient has substance abuse history or any other medical conditions such as
clinically significant cardiac or psychological conditions, that may, in the opinion
of the investigator, interfere with the patient's participation in the clinical
study or evaluation of the clinical study results.
19. Person deprived of their liberty or under protective custody or guardianship.
20. Social, familial, or geographic factors that would interfere with study
participation or follow-up.
Inclusion criteria
1. Patient must have signed the written informed consent for screening phase prior to
any trial specific procedures.
Note: 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 writing the patient's consent.
2. Patient is ≥18 years of age.
3. Documented breast cancer that:
- Is metastatic and eligible to biopsy for subsequent histological or cytological
confirmation,
- Is HER2 low (HER2 1+, or 2+ and in situ hybridization (ISH) negative) or HER2
ultra low (IHC 0 with incomplete and faint membrane staining in >0 and ≤10% of
tumor cells) on the most recent tumor material available, as defined by the
local pathologist under ASCO/CAP guidelines,
- Is HR-positive (positive for estrogen receptor or progesterone receptor ≥10% of
tumor cell nuclei are immunoreactive) in the metastatic setting.
4. Patient has either:
- a metastatic relapse during or within 1 year after termination of the adjuvant
endocrine therapy (AI resistant), or
- a metastatic relapse more than one year of completing adjuvant AI or a de-novo
metastatic breast cancer (AI sensitive/naive).
5. For AI resistant population: patient has previously gone through the ctDNA screening
part of the SAFIR 03 - SCREENING/ARRIBA study and fulfilled all the inclusion
criteria and none of the exclusion criteria.
6. Patient did not receive any therapy in the metastatic setting.
7. Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor
(palbociclib, ribociclib, or abemaciclib) in combination with either AI or
fulvestrant, according to its marketing authorisation.
8. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
9. Patient has an adequate bone marrow and organ function.
10. Patient has a measurable or an evaluable disease according to Response Evaluation
Criteria In Solid Tumours version 1.1 (RECIST v1.1).
11. Availability of an archived metastatic tumor sample (FFPE) for exploratory research.
Bone metastasis are accepted if tissue is representative of tumor tissue (at least
10% tumor cellularity).
12. Patient must be willing and able to comply with the protocol for the duration of the
study including scheduled visits, treatment plan, laboratory tests and other study
procedures.
13. Registration in a National Health Care System (or equivalent).
Exclusion criteria:
1. Patient is eligible to chemotherapy because of visceral crisis.
2. Patient has a breast cancer amenable for resection or radiation therapy with
curative intent.
3. Prior exposure to antibody-drug conjugate or CDK4/6 inhibitors (in metastatic
setting). CDK4/6 inhibitors given in adjuvant setting must be stopped for at least
12 months prior screening
4. Patient who has initiated the CDK4/6 inhibitor treatment.
5. Patient is unable to swallow tablets.
6. Patient has a history of (non-infectious) interstitial lung disease
(ILD)/pneumonitis requiring steroids, has current ILD/pneumonitis, or where
suspected ILD/pneumonitis cannot be ruled out by imaging at baseline
7. Patient has a history of severe hypersensitivity reactions to either the drug
substances or inactive ingredients in the drug product.
8. Patient has a history of severe hypersensitivity reactions to other monoclonal
antibodies.
9. Person deprived of their liberty or under protective custody or guardianship.
10. Social, familial, or geographic factors that would interfere with study
participation or follow-up.
TREATMENT PHASE_________________________________________________________
Inclusion criteria
1. Patient must have signed the written informed consent for the treatment phase prior
to any trial specific procedures.
Note: 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 writing the patient's consent.
2. Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or
abemaciclib) at least 7 days before enrolment, but no longer than 14 days
3. Patients must present a no drop of ctDNA determined by a ctDNA assay after 4 weeks
of standard of care treatment with a CDK4/6 inhibitor
4. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
5. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to enrolment.
6. Participant has adequate bone marrow and organ function within 14 days before
enrolment, defined as the following laboratory values:
- Absolute neutrophil count (ANC) ≥1500/mm³,
- platelet count ≥100,000/mm³,
- haemoglobin ≥9.0 g/dl,
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥30
mL/min,
- Serum albumin ≥2.5 g/dL,
- Total bilirubin ≤1.5 × ULN (<3 ULN if Gilbert's disease),
- In absence of liver metastases, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤3 × ULN. If the participant has liver metastases, ALT
and AST < 5 × ULN, he/she will be eligible for the study,
- Adequate blood clotting function: defined as an international normalized
ratio/prothrombin time ≤1.5 × ULN and either partial thromboplastin time or
activated partial thromboplastin time within normal limits.
Note: Transfusion (red blood cell or platelet) or G-CSF administration is not
allowed within 14 days prior to the day on which bone marrow function is assessed,
or at any time after this day and prior to cycle 1 day 1.
7. Women of childbearing potential must have a negative serum pregnancy test (with a
sensitivity of at least 25 mIU/mL) result within 3 days of enrolment.
8. Men or women of childbearing potential must agree to the use of effective
contraceptive for the study duration and for at least 7 months after the last dose
of study treatment for women, and at least 4 months for men.
9. Patient must be willing and able to comply with the protocol for the duration of the
study including scheduled visits, treatment plan, laboratory tests and other study
procedures.
Exclusion criteria:
1. AI resistant patients who are eligible to SAFIR 03 - ARRIBA trial (i.e. PIK3CA
mutated patients), until SAFIR 03 - ARRIBA study closure or study steering
committee's decision.
2. Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment
combined with either AI or fulvestrant.
3. Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14
days.
4. Patient has evidence of clinical or radiological disease progression.
5. Patient has unresolved toxicities from previous anticancer therapy, defined as
toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
Note: Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as
no worsening to >Grade 2 for at least 3 months prior to enrolment and managed with
standard of care treatment) that the investigator deems related to previous
anticancer therapy, such as: Chemotherapy-induced neuropathy and fatigue.
6. Patient has malignancies within 3 years, other than that under study, with the
exception of: adequately resected non-melanoma skin cancer, curatively treated
in-situ disease, other solid tumors curatively treated, or contralateral breast
cancer.
7. Patient is at high medical risk because of severe or uncontrolled systemic disease,
such as uncontrolled diabetes mellitus, clinically significant pulmonary disease,
clinically significant neurological disorder, chronic pancreatitis, chronic active
infection with hepatitis B virus, hepatitis C virus, or HIV, active untreated or
uncontrolled fungal, bacterial or viral infections, active primary immunodeficiency
etc.
8. Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment,
- History of symptomatic congestive heart failure (New York Heart Association
Class II to IV),
- Patient with a corrected QT interval (QTc) prolongation to >470 ms (females) or
>450 ms (males) based on average of the screening triplicate12-lead ECG,
- Patients with known troponin levels above ULN at screening (as defined by the
manufacturer), and without any myocardial related symptoms, should have a
cardiologic consultation before enrolment to rule out myocardial infarction.
9. Clinically severe pulmonary compromise resulting from current pulmonary illnesses
including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary
emboli within three months of the study enrolment, severe asthma, severe chronic
obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion,
etc.), and any autoimmune, connective tissue, or inflammatory disorders with
pulmonary involvement (i.e., rheumatoid arthritis, Sjögren's, sarcoidosis, etc.), or
prior pneumonectomy.
10. Patient has spinal cord compression or clinically active central nervous system
metastases, defined as untreated or symptomatic, or requiring therapy with
corticosteroids or anticonvulsants to control associated symptoms.
11. Major surgery within 4 weeks before study enrolment.
12. Patient who has received radiotherapy ≤4 weeks or limited field radiation for
palliation ≤2 weeks prior to enrolment, or who has not recovered to grade 1 or
better from related side effects of such therapy (exceptions include alopecia)
and/or in whom ≥25% of the bone marrow was irradiated
13. Patient using drugs that could have pharmacokinetics interaction with
investigational drugs. Concomitant use of strong CYP3A4 inhibitors or OATP 1B
inhibitors should be avoided. If concomitant use of strong CYP3A4 or OATP 1B
inhibitors is unavoidable, consider delaying T-DXd treatment until the inhibitors
have cleared from the circulation (approximately 3 elimination half-lives of the
inhibitors) when possible. If a strong CYP3A4 inhibitor or an OATP 1B inhibitor is
co-administered and T-DXd treatment cannot be delayed, patients should be closely
monitored for adverse reactions.
14. Patient receiving drug that may cause QTc prolongations or cardiac arrhythmia.
Pimozide (Orap®) and cisapride (Prepulsid®) are strictly contraindicated: they are
associated with a major risk of ventricular rhythm disorder.
15. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral
vaccines are not considered attenuated live vaccines) within 30 days prior to the
first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not
receive live vaccine during the study and up to 30 days after the last dose of
T-DXd.
16. Participation in a therapeutic clinical study within 4 weeks before enrolment.
17. Patient is currently pregnant, breastfeeding, or planning to become pregnant
18. Patient has substance abuse history or any other medical conditions such as
clinically significant cardiac or psychological conditions, that may, in the opinion
of the investigator, interfere with the patient's participation in the clinical
study or evaluation of the clinical study results.
19. Person deprived of their liberty or under protective custody or guardianship.
20. Social, familial, or geographic factors that would interfere with study
participation or follow-up.