Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
NCT ID: NCT06680596
Last Updated: 2025-09-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
PHASE2
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-07-30
Study Completion Date
2029-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
NCT05950945
Breast Cancer
RECRUITING
PHASE3
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT06585969
Metastatic Breast Cancer
ER-positive Breast Cancer
Luminal B
+2 more
NOT_YET_RECRUITING
PHASE3
Trial of Trastuzumab Deruxtecan in Previously Treated HER2
NCT06750484
Breast Cancer Metastatic
RECRUITING
PHASE2
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
NCT06486883
Advanced Breast Cancer
Advanced Breast Carcinoma
Hormone Receptor Positive Breast Carcinoma
RECRUITING
PHASE2
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
NCT05592483
Breast Cancer
TERMINATED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible patients to the screening phase are patients with hormone receptor positive (estrogen receptor and/or progesterone receptor \>10%) and HER2 low or ultralow metastatic breast cancer who will receive standard first line therapy with CDK4-6i (any from the market), combined with aromatase inhibitor or fulvestrant. Patient persistence of tumor DNA in the blood at 4 weeks of this standard therapy will be included in the treatment phase with trastuzumab deruxtecan (T-DXd).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Breast Cancer Metastatic
Breast Cancer Stage IV
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
After an initial screening phase to identify patients with blood circulating tumours persistent, 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).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
T-DXd
T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).
Group Type
EXPERIMENTAL
trastuzumab derxutecan
Intervention Type
DRUG
T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
trastuzumab derxutecan
T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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).
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).
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.
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).
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).
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. 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\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
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.
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\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Sponsor Role
collaborator
Breast Cancer Research Foundation
OTHER
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fabrice ANDRE, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Amiens Picardie
Amiens, , France
Site Status
Clinique de L'Europe Amiens - Cthe
Amiens, , France
Site Status
Centre Hospitalier D'Auxerre
Auxerre, , France
Site Status
Sainte Catherine Institut Du Cancer Avignon Provence
Avignon, , France
Site Status
Centre Hospitalier de la Côte Basque
Bayonne, , France
Site Status
Centre Hospitalier de Beauvais
Beauvais, , France
Site Status
Hôpital Simone Veil de Blois
Blois, , France
Site Status
Chu de Brest - Hôpital Cavale Blanche
Brest, , France
Site Status
Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante
Brest, , France
Site Status
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
Site Status
Centre Hospitalier de Cholet
Cholet, , France
Site Status
Pôle Santé République (Elsan)
Clermont-Ferrand, , France
Site Status
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, , France
Site Status
Chi Fréjus-Saint-Raphaël
Fréjus, , France
Site Status
Chd Vendée
La Roche-sur-Yon, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Hopital Prive Jean Mermoz
Lyon, , France
Site Status
Clinique de La Sauvegarde
Lyon, , France
Site Status
Institut Paoli Calmettes
Marseille, , France
Site Status
Icm Val D'Aurelle
Montpellier, , France
Site Status
Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly)
Nancy, , France
Site Status
Centre Antoine Lacassagne
Nice, , France
Site Status
Hôpital Saint-Louis
Paris, , France
Site Status
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, , France
Site Status
Centre Hospitalier de Pau
Pau, , France
Site Status
Hopital Privé Des Côtes D'Armor (Hpca) - Cario
Plérin, , France
Site Status
Institut Godinot
Reims, , France
Site Status
Centre Eugene Marquis
Rennes, , France
Site Status
Chp Saint-Grégoire - Groupe Vivalto Sante
Saint-Grégoire, , France
Site Status
Clinique Sainte-Anne - Gh Saint-Vincent
Strasbourg, , France
Site Status
Hôpitaux Du Léman
Thonon-les-Bains, , France
Site Status
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-515349-41-00
Identifier Type: CTIS
Identifier Source: secondary_id
UC-GMP-2402
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
NCT04494425
ACTIVE_NOT_RECRUITING
PHASE3
Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer
NCT05965479
RECRUITING
PHASE2
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
NCT05113251
ACTIVE_NOT_RECRUITING
PHASE3
T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients
NCT05953168
NOT_YET_RECRUITING
PHASE2
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
NCT05744375
TERMINATED
PHASE2
Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
NCT06837792
RECRUITING
PHASE2
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
NCT04639219
ACTIVE_NOT_RECRUITING
PHASE2
Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients
NCT00485979
COMPLETED
PHASE2
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
NCT02748213
COMPLETED
PHASE2
Chemotherapy Monitoring by ctDNA in HER2- Metastatic Breast Cancer
NCT04720729
TERMINATED
PHASE2
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
NCT04538742
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
NCT06533826
RECRUITING
PHASE2
Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases
NCT04752059
COMPLETED
PHASE2
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
NCT05458401
COMPLETED
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
NCT05900206
RECRUITING
PHASE2
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast Cancer
NCT00005970
COMPLETED
PHASE3
A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
NCT07281001
RECRUITING
NA
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
NCT04482309
RECRUITING
PHASE2
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
NCT01334021
ACTIVE_NOT_RECRUITING
PHASE2
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
NCT05826964
ACTIVE_NOT_RECRUITING
PHASE2
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
NCT03734029
ACTIVE_NOT_RECRUITING
PHASE3
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
NCT02605915
COMPLETED
PHASE1
DESTINY Breast Respond HER2-low Europe
NCT05945732
RECRUITING
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
NCT04553770
RECRUITING
PHASE2
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
NCT00429247
COMPLETED
PHASE2