Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
NCT ID: NCT05625087
Last Updated: 2025-08-20
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
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
162 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-19
Study Completion Date
2030-06-30
Brief Summary
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After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
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Detailed Description
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INDICATION The population eligible to the screening phase is composed of all women or men with HR+, HER2- metastatic breast cancer who are eligible for first-line treatment with a cyclin-dependent kinases (CDK) 4/6 inhibitor combined with fulvestrant (and a luteinizing hormone realeasing hormone (LH-RH) analogue in men and premenopausal women) in the context of the standard healthcare management. The screening will identify patients with high risk of relapse on any CDK4/6 inhibitor thanks to ctDNA kinetic between baseline and 4 weeks of treatment. The purpose is to early adapt the therapeutic intervention for ctDNA no drop patient to prevent from relapse. This study will propose an intervention for PIK3CA mutated patients with alpelisib vs. ribociclib. Other therapeutic approaches might be proposed to patients with wild type PIK3CA through other protocols.
The randomised study phase will include patients with persistent mutations on exons 4, 9 or 20\* of PIK3CA ctDNA after 4 weeks of treatment with any CDK4/6 inhibitor-fulvestrant in first-line setting.
The randomised study phase will include patients with persistent mutations on exons 4, 9 or 20\* of PIK3CA ctDNA after 4 weeks of treatment with any CDK4/6 inhibitor-fulvestrant in first-line setting.
Conditions
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Breast Cancer Stage IV
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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ALPELISIB ARM
Oral alpelisib (300 mg daily, in 28-day cycle) and fulvestrant as per standard practice. Moreover, men and premenopausal women will receive an LH-RH analogue (goserelin, leuprorelin, or triptorelin) every 28 days ±3 days, as per standard practice
Group Type
EXPERIMENTAL
Alpelisib
Intervention Type
DRUG
Alpelisib 300 mg once daily + fulvestrant 500 mg every 28 days
RIBOCICLIB ARM
Oral ribociclib (600 mg daily, 3 weeks on, then 1 week off treatment in 28-day cycles) and fulvestrant as per standard practice. Moreover, men and premenopausal women will receive an LH-RH analogue (goserelin, leuprorelin, or triptorelin) every 28 days ±3 days, as per standard practice.
Group Type
ACTIVE_COMPARATOR
Ribociclib
Intervention Type
DRUG
Ribocilcib 600 mg once daily 3 weeks on/1 week off + fulvestrant 500 mg every 28 days
Interventions
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Alpelisib
Alpelisib 300 mg once daily + fulvestrant 500 mg every 28 days
Intervention Type
DRUG
Ribociclib
Ribocilcib 600 mg once daily 3 weeks on/1 week off + fulvestrant 500 mg every 28 days
Intervention Type
DRUG
Other Intervention Names
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Fulvestrant
Fulvestrant
Eligibility Criteria
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Inclusion Criteria
1. Patient must have signed a written informed consent prior to any study-specific screening procedures (the consent form specifically for the screening phase must be signed).
2. Patient is ≥18 years of age.
3. Patient has an histologically or cytologically confirmed metastatic breast cancer.
4. Patient has a HER2- breast cancer (without HER2 overexpression according to the ASCO-CAP 2018 guidelines).
5. Patient has hormone receptor-positive (HR+) breast cancer, defined as having oestrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥10% of tumour cells.
6. Patient had a metastatic relapse during or within 1 year after termination of the adjuvant endocrine therapy.
7. Patient has not yet been treated in the metastatic breast cancer setting.
8. Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) in combination with fulvestrant, according to its marketing authorisation.
9. Eastern Cooperative Oncology Group (ECOG) performance status is ≤1.
10. Patient has an adequate bone marrow and organ function.
11. Measurable or evaluable disease according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
12. Patients 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. Patient must be affiliated to the national social security (or equivalent).
1. Patient must have signed a written informed consent prior to any procedures for the randomised study phase (the consent form specifically for the randomised study phase must be signed).
2. Patient has a circulating PIK3CA level of exon 4, 9 or 20 mutant\* of PIK3CA ctDNA determined by circulating tumour DNA (ctDNA) assay after 4 weeks of treatment with any CDK4/6 inhibitor combined with fulvestrant.
3. Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) at least 7 days before randomisation.
4. ECOG performance status is ≤1.
5. Patient's life expectancy is deemed ≥3 months.
6. Patient has an adequate bone marrow and organ function as defined by the following laboratory values:
* Absolute neutrophil count (ANC) ≥1500/mm³,
* Platelet count ≥100,000/mm³,
* Haemoglobin ≥9.0 g/dL,
* International normalised ratio (INR) ≤1.5 (unless the participant is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug),
* Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL/min,
* Total bilirubin ≤2× ULN (\<3 ULN with documented Gilbert's disease) or direct bilirubin ≤ 1.5 × ULN,
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or \<5.0 x ULN if patient has liver metastasis,
* Fasting Serum amylase ≤ 2 × ULN,
* Fasting Serum lipase ≤ ULN,
* Fasting plasma glucose (FPG) ≤140 mg/dL (or ≤7.7 mmol/L) and glycosylated haemoglobin (HbA1c) ≤6.4%.
7. Participant must have the following laboratory values within normal limits or corrected to within normal limits with supplements before randomisation
* Potassium
* Magnesium
* Total Calcium (corrected for serum albumin)
8. Patient with parameters of standard 12-lead ECG (defined as the mean of triplicate ECGs performed) as follows, before randomisation:
* QTcF interval \<450ms (using Fridericia's correction),
* Resting heart rate between 50-90 bpm.
9. Women of childbearing potential must have a negative serum pregnancy test result within 14 days of enrolment in the randomised trial phase.
10. Men or Women of childbearing potential must agree to the use of effective contraceptive for the study duration and for at least 2 year after the last dose of study treatment for women, and at least 21 days for men.
11. Patients 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.
* Also numbered exon 5, 10 and 21 according to recent classification: Ensembl Transcript ID: ENST00000263967.4, RefSeq: NM\_006218.4.
2. Patient is ≥18 years of age.
3. Patient has an histologically or cytologically confirmed metastatic breast cancer.
4. Patient has a HER2- breast cancer (without HER2 overexpression according to the ASCO-CAP 2018 guidelines).
5. Patient has hormone receptor-positive (HR+) breast cancer, defined as having oestrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥10% of tumour cells.
6. Patient had a metastatic relapse during or within 1 year after termination of the adjuvant endocrine therapy.
7. Patient has not yet been treated in the metastatic breast cancer setting.
8. Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) in combination with fulvestrant, according to its marketing authorisation.
9. Eastern Cooperative Oncology Group (ECOG) performance status is ≤1.
10. Patient has an adequate bone marrow and organ function.
11. Measurable or evaluable disease according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
12. Patients 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. Patient must be affiliated to the national social security (or equivalent).
1. Patient must have signed a written informed consent prior to any procedures for the randomised study phase (the consent form specifically for the randomised study phase must be signed).
2. Patient has a circulating PIK3CA level of exon 4, 9 or 20 mutant\* of PIK3CA ctDNA determined by circulating tumour DNA (ctDNA) assay after 4 weeks of treatment with any CDK4/6 inhibitor combined with fulvestrant.
3. Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) at least 7 days before randomisation.
4. ECOG performance status is ≤1.
5. Patient's life expectancy is deemed ≥3 months.
6. Patient has an adequate bone marrow and organ function as defined by the following laboratory values:
* Absolute neutrophil count (ANC) ≥1500/mm³,
* Platelet count ≥100,000/mm³,
* Haemoglobin ≥9.0 g/dL,
* International normalised ratio (INR) ≤1.5 (unless the participant is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug),
* Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL/min,
* Total bilirubin ≤2× ULN (\<3 ULN with documented Gilbert's disease) or direct bilirubin ≤ 1.5 × ULN,
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or \<5.0 x ULN if patient has liver metastasis,
* Fasting Serum amylase ≤ 2 × ULN,
* Fasting Serum lipase ≤ ULN,
* Fasting plasma glucose (FPG) ≤140 mg/dL (or ≤7.7 mmol/L) and glycosylated haemoglobin (HbA1c) ≤6.4%.
7. Participant must have the following laboratory values within normal limits or corrected to within normal limits with supplements before randomisation
* Potassium
* Magnesium
* Total Calcium (corrected for serum albumin)
8. Patient with parameters of standard 12-lead ECG (defined as the mean of triplicate ECGs performed) as follows, before randomisation:
* QTcF interval \<450ms (using Fridericia's correction),
* Resting heart rate between 50-90 bpm.
9. Women of childbearing potential must have a negative serum pregnancy test result within 14 days of enrolment in the randomised trial phase.
10. Men or Women of childbearing potential must agree to the use of effective contraceptive for the study duration and for at least 2 year after the last dose of study treatment for women, and at least 21 days for men.
11. Patients 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.
* Also numbered exon 5, 10 and 21 according to recent classification: Ensembl Transcript ID: ENST00000263967.4, RefSeq: NM\_006218.4.
Exclusion Criteria
1. Prior exposure to PIK3CA-AKT or CDK4/6 inhibitors.
2. Patient that has initiated the CDK4/6 inhibitor treatment.
3. Patient with spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for ≥30 days before initiating the study treatment).
4. Participant with an established diagnosis of diabetes mellitus type I or not controlled type II (based on FG and HbA1c).
5. Patient unable to swallow tablets.
6. Patient with known hypersensitivity to any of the study treatment excipients, in particular patients with allergies to soya or peanuts.
7. Patients with a history of malabsorption syndrome or other condition that may interfere with enteral absorption: including but not limited to active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy.
8. Patient with any condition/disease for which the investigator considers that participating in the study is inappropriate or that may jeopardize treatment and protocol compliance.
9. Patient deprived of liberty or under the authority of a tutor.
RANDOMISED PHASE ( SAFIR 03 -ARRIBA)
1. Patient is eligible to chemotherapy because of visceral crisis.
2. Pregnant or lactating women.
3. Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment combined with fulvestrant before randomisation.
4. Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14 days before randomisation.
5. Patient has evidence of clinical or radiological disease progression before randomisation.
6. Patient has unresolved adverse events (grade ≥1), except alopecia and grade ≥2 unresolved adverse events related to fulvestrant or the LH-RH analogue which are acceptable to randomisation.
7. Patient is considered at high medical risk because of severe or uncontrolled systemic disease, including but not limited to diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, chronic pancreatitis, chronic active hepatitis, active untreated/uncontrolled fungal, bacterial, or viral infections, as well as known active viral infections with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
8. Participant has currently documented pneumonitis/interstitial lung disease (the chest CT scan performed before start of study treatment for the purpose of tumour assessment should be reviewed to confirm that there are no relevant pulmonary complications present).
9. Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
10. Participant with unresolved osteonecrosis of the jaw.
11. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities including any of the following:
* Uncontrolled hypertension,
* Symptomatic congestive heart failure: New York Heart Association (NYHA) class ≥2,
* Unstable angina pectoris,
* Stroke or myocardial infarction within the 6 months before randomisation,
* Serious cardiac arrhythmia requiring treatment, except treated atrial fibrillation and paroxysmal supraventricular tachycardia, or conduction abnormality for which the patient is no longer at risk of serious arrhythmia (e.g., Patient with Wolff-Parkinson-White syndrome treated with surgical ablation),
* Left ventricular ejection fraction (LVEF) \<50% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) before randomisation.
* Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following before randomisation:
* Presence of risk factors for Torsades de Pointe, including uncorrected hypokalaemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia,
* Concomitant use of medication(s) known to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to initiating the study treatment) or cannot be replaced by a safe alternative,
* Unable to determine the QTcF (using Fridericia's correction),
* Systolic blood pressure (SBP) \>160 mmHg or \<90 mmHg.
12. Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, 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 is currently consuming any of the following foods, supplements, herbal preparations or medications that cannot be discontinued within 7 days of initiating the study treatment:
* Known strong inducers or inhibitors of CYP3A4/5 (including grapefruits),
* Medications predominantly metabolised through CYP3A4/5, with a narrow therapeutic window,
14. Patient has known hypersensitivity to any of the study treatment excipients, in particular patients with allergies to soya or peanuts.
15. Patient is or plans to participate in another interventional therapeutic clinical trial. Concurrent participation in an observational study is acceptable.
16. Patient has malignancies, other than that under study, except for adequately treated cone-biopsied in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, with no evidence of relapse/recurrence within ≥5 years, and at negligible risk for recurrence are eligible for the study.
17. Patient has any condition/disease, for which the investigator considers that participating in the trial is inappropriate or that may jeopardize treatment and protocol compliance.
18. Patient deprived of liberty or under the authority of a tutor.
2. Patient that has initiated the CDK4/6 inhibitor treatment.
3. Patient with spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for ≥30 days before initiating the study treatment).
4. Participant with an established diagnosis of diabetes mellitus type I or not controlled type II (based on FG and HbA1c).
5. Patient unable to swallow tablets.
6. Patient with known hypersensitivity to any of the study treatment excipients, in particular patients with allergies to soya or peanuts.
7. Patients with a history of malabsorption syndrome or other condition that may interfere with enteral absorption: including but not limited to active intestine inflammation (e.g., Crohn's disease or ulcerative colitis) requiring immunosuppressive therapy.
8. Patient with any condition/disease for which the investigator considers that participating in the study is inappropriate or that may jeopardize treatment and protocol compliance.
9. Patient deprived of liberty or under the authority of a tutor.
RANDOMISED PHASE ( SAFIR 03 -ARRIBA)
1. Patient is eligible to chemotherapy because of visceral crisis.
2. Pregnant or lactating women.
3. Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment combined with fulvestrant before randomisation.
4. Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14 days before randomisation.
5. Patient has evidence of clinical or radiological disease progression before randomisation.
6. Patient has unresolved adverse events (grade ≥1), except alopecia and grade ≥2 unresolved adverse events related to fulvestrant or the LH-RH analogue which are acceptable to randomisation.
7. Patient is considered at high medical risk because of severe or uncontrolled systemic disease, including but not limited to diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, chronic pancreatitis, chronic active hepatitis, active untreated/uncontrolled fungal, bacterial, or viral infections, as well as known active viral infections with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
8. Participant has currently documented pneumonitis/interstitial lung disease (the chest CT scan performed before start of study treatment for the purpose of tumour assessment should be reviewed to confirm that there are no relevant pulmonary complications present).
9. Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
10. Participant with unresolved osteonecrosis of the jaw.
11. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities including any of the following:
* Uncontrolled hypertension,
* Symptomatic congestive heart failure: New York Heart Association (NYHA) class ≥2,
* Unstable angina pectoris,
* Stroke or myocardial infarction within the 6 months before randomisation,
* Serious cardiac arrhythmia requiring treatment, except treated atrial fibrillation and paroxysmal supraventricular tachycardia, or conduction abnormality for which the patient is no longer at risk of serious arrhythmia (e.g., Patient with Wolff-Parkinson-White syndrome treated with surgical ablation),
* Left ventricular ejection fraction (LVEF) \<50% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) before randomisation.
* Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following before randomisation:
* Presence of risk factors for Torsades de Pointe, including uncorrected hypokalaemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia,
* Concomitant use of medication(s) known to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to initiating the study treatment) or cannot be replaced by a safe alternative,
* Unable to determine the QTcF (using Fridericia's correction),
* Systolic blood pressure (SBP) \>160 mmHg or \<90 mmHg.
12. Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, 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 is currently consuming any of the following foods, supplements, herbal preparations or medications that cannot be discontinued within 7 days of initiating the study treatment:
* Known strong inducers or inhibitors of CYP3A4/5 (including grapefruits),
* Medications predominantly metabolised through CYP3A4/5, with a narrow therapeutic window,
14. Patient has known hypersensitivity to any of the study treatment excipients, in particular patients with allergies to soya or peanuts.
15. Patient is or plans to participate in another interventional therapeutic clinical trial. Concurrent participation in an observational study is acceptable.
16. Patient has malignancies, other than that under study, except for adequately treated cone-biopsied in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, with no evidence of relapse/recurrence within ≥5 years, and at negligible risk for recurrence are eligible for the study.
17. Patient has any condition/disease, for which the investigator considers that participating in the trial is inappropriate or that may jeopardize treatment and protocol compliance.
18. Patient deprived of liberty or under the authority of a tutor.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Novartis
INDUSTRY
Sponsor Role
collaborator
Breast Cancer Research Foundation
OTHER
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Fabrice ANDRE
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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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
Institut Bergonié
Bordeaux, , France
Site Status
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, , France
Site Status
CHRU Morvan
Brest, , France
Site Status
Clinique Pasteur Lanroze - CFRO - Groupe Vivalto Santé
Brest, , France
Site Status
Centre François Baclesse
Caen, , France
Site Status
Hôpital NOVO
Cergy-Pontoise, , 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
Clinique de Flandre
Coudekerque-Branche, , France
Site Status
CHI Fréjus-Saint-Raphaël
Fréjus, , France
Site Status
Groupe Hospitalier Mutualiste de Grenoble (GHMG)
Grenoble, , France
Site Status
CHD Vendée
La Roche-sur-Yon, , France
Site Status
Centre Hospitalier de Versailles - Hôpital André Mignot
Le Chesnay, , France
Site Status
Polyclinique de Limoges - Site François Chénieux
Limoges, , France
Site Status
Centre Léon Bérard
Lyon, , France
Site Status
Hôpital privé 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
Clinique Hartmann
Neuilly-sur-Seine, , 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
Hôpital Privé des Côtes-d'Armor (HPCA) - Cario
Plérin, , France
Site Status
Institut Godinot
Reims, , France
Site Status
Centre Eugène Marquis
Rennes, , France
Site Status
CHP Saint-Grégoire - Groupe Vivalto Santé
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 Claudius Regaud - IUCT-O
Toulouse, , France
Site Status
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Site Status
Gustave Roussy
Villejuif, , France
Site Status
Countries
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France
Other Identifiers
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EU CT
Identifier Type: OTHER
Identifier Source: secondary_id
UC-GMP-2206
Identifier Type: -
Identifier Source: org_study_id
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WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
NCT03854903
COMPLETED
PHASE1
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
NCT04060862
TERMINATED
PHASE1
A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer
NCT03803761
WITHDRAWN
PHASE1/PHASE2
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
NCT02536742
COMPLETED
PHASE2
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
NCT05384119
TERMINATED
PHASE1
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
NCT02491983
COMPLETED
PHASE2
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
NCT05631795
COMPLETED
PHASE4
TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.
NCT04498481
COMPLETED
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
NCT05091528
TERMINATED
PHASE1/PHASE2
Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
NCT05512780
UNKNOWN
PHASE2
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
NCT06856200
RECRUITING
NA
PF-07104091 as a Single Agent and in Combination Therapy
NCT04553133
ACTIVE_NOT_RECRUITING
PHASE2
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
NCT04191499
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
NCT02771795
TERMINATED
Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer
NCT03195192
COMPLETED
NA
Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer
NCT05569187
COMPLETED
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies
NCT05226871
ACTIVE_NOT_RECRUITING
PHASE2
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
NCT07002177
RECRUITING
PHASE1/PHASE2
Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
NCT03709082
TERMINATED
PHASE1/PHASE2