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Breast Cancer MetastaticPhase 2SAFIR3LibHERtyNCT06680596

Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy

A Phase 2 study testing trastuzumab derxutecan in people with Breast Cancer Metastatic and Breast Cancer Stage IV, run by UNICANCER at 40 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
trastuzumab derxutecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
40 sitesFrance
Study dates
30 Jul 2025to 1 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must have signed 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.
  • Patient is ≥18 years of age.
  • 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,
Show all 38Show fewer
  • Is HR-positive (positive for estrogen receptor or progesterone receptor ≥10% of tumor cell nuclei are immunoreactive) in the metastatic setting.
  • 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).
  • 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.
  • Patient did not receive any therapy in the metastatic setting.
  • 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.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  • Patient has an adequate bone marrow and organ function.
  • Patient has a measurable or an evaluable disease according to Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1).
  • 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).
  • 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.
  • Registration in a National Health Care System (or equivalent).
  • 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.
  • Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) at least 7 days before enrolment, but no longer than 14 days
  • 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
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
  • Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to enrolment.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Patient is eligible to chemotherapy because of visceral crisis.
  • Patient has a breast cancer amenable for resection or radiation therapy with curative intent.
  • 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
  • Patient who has initiated the CDK4/6 inhibitor treatment.
  • Patient is unable to swallow tablets.
  • 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
Show all 36Show fewer
  • Patient has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
  • Patient has a history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Person deprived of their liberty or under protective custody or guardianship.
  • Social, familial, or geographic factors that would interfere with study participation or follow-up.
  • TREATMENT PHASE
  • 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.
  • Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment combined with either AI or fulvestrant.
  • Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14 days.
  • Patient has evidence of clinical or radiological disease progression.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Major surgery within 4 weeks before study enrolment.
  • 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
  • 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.
  • 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.
  • 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.
  • Participation in a therapeutic clinical study within 4 weeks before enrolment.
  • Patient is currently pregnant, breastfeeding, or planning to become pregnant
  • 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.
  • Person deprived of their liberty or under protective custody or guardianship.
  • Social, familial, or geographic factors that would interfere with study participation or follow-up.

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François LEGRAND contact

01 73 79 73 02 ext. +33

safir03libherty@unicancer.fr

Marta JIMENEZ contact

m-jimenez@unicancer.fr

40 sites in 1 country

France40 sites, 40 recruiting

  • Chu Amiens Picardie

    Amiens, 80054

    Aurélie MOREIRA, 02 22 45 54 99, moreira.aurelie@chu-amiens.fr

    Not yet recruiting

  • Clinique de L'Europe Amiens - Cthe

    Amiens, 80090

    David DEFEVER, 03 60 12 53 43, david.defever@cthe-amiens.fr

    Not yet recruiting

  • Centre Hospitalier D'Auxerre

    Auxerre, 89000

    Adina MARTI, 03 86 48 47 65, amarti@ch-auxerre.fr

    Not yet recruiting

  • Sainte Catherine Institut Du Cancer Avignon Provence

    Avignon, 84918

    Bertrand BILLEMONT, 04 90 27 63 97, b.billemont@isc84.org

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

    Thomas GRELLETY, 05 33 78 81 27, tgrellety@ch-cotebasque.fr

    Not yet recruiting

  • Centre Hospitalier de Beauvais

    Beauvais, 60021

    Hanifa AMMARGUELLAT, 03 44 11 21 23, h.ammarguellat@ch-beauvais.fr

    Recruiting

  • Institut de Cancerologie Des Hauts de France - Centre Pierre Curie

    Beuvry, 62660

    Laurent BASSON, 03 21 61 66 82, Laurent.basson@ichf.fr

    Not yet recruiting

  • Hôpital Simone Veil de Blois

    Blois, 41000

    Olivier ARSENE, 02 54 55 64 05, arseneo@ch-blois.fr

    Not yet recruiting

  • Centre Hospitalier de Boulogne-Sur-Mer

    Boulogne-sur-Mer, 62321

    Abeer NAJEM, Dr, 03 21 99 30 13, a.najem@ch-boulogne.fr

    Not yet recruiting

  • Centre Hospitalier de Boulogne-Sur-Mer

    Boulogne-sur-Mer, 62321

    Abeer NAJEM, 03 21 99 30 13, a.najem@ch-boulogne.fr

    Not yet recruiting

  • Chu de Brest - Hôpital Cavale Blanche

    Brest, 29200

    Laura DEIANA, 02 98 22 33 95, laura.deiana@chu-brest.fr

    Recruiting

  • Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante

    Brest, 29200

    Matthieu CHASSERAY, 02 98 31 30 07, m.chasseray@oncologie-brest.fr

    Not yet recruiting

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

    Thomas COLLOT, 03 85 44 66 88, thomas.collot@ch-chalon71.fr

    Recruiting

  • Centre Hospitalier de Cholet

    Cholet, 49300

    Victor SIMMET, 02 41 49 62 31, victor.simmet@ch-cholet.fr

    Recruiting

  • Pôle Santé République (Elsan)

    Clermont-Ferrand, 63000

    Pierre DALLOZ, 04 73 99 43 90, pdalloz@polesanterepublique.com

    Not yet recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Xavier DURANDO, 04 73 27 80 05, xavier.durando@clermont.unicancer.fr

    Recruiting

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

    Mansour RASTKHAH, 04 50 82 22 70, mrastkhah@ch-alpes-leman.fr

    Not yet recruiting

  • Clinique de Flandre

    Coudekerque-Branche, 59210

    Jean-Baptiste AISENFARB, Dr, 03 28 28 14 39, jbaisenfarb@iadonco.org

    Not yet recruiting

  • Chi Fréjus-Saint-Raphaël

    Fréjus, 83608

    Jean-François PAITEL, 04 94 55 87 83, paitel-j@chi-fsr.fr

    paitel-j@chi-fsr.fr

    Not yet recruiting

  • Chd Vendée

    La Roche-sur-Yon, 85925

    Camille GOISLARD DE MONSABERT, 02 51 44 61 73, camille.goislard-demonsabert@ght85.fr

    Not yet recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Thomas BACHELOT, 04 78 78 36 54, thomas.bachelot@lyon.unicancer.fr

    Recruiting

  • Hopital Prive Jean Mermoz

    Lyon, 69008

    Olfa DERBEL MILED, 04 37 53 87 25, o.derbelmermoz@gmail.com

    Not yet recruiting

  • Clinique de La Sauvegarde

    Lyon, 69009

    Yann MOLIN, 04 37 49 18 20, dryannmolin@gmail.com

    Not yet recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Alexandre TASSIN DE NONNEVILLE, 04 91 22 33 33, TASSINDENONNEVILLEA@ipc.unicancer.fr

    Not yet recruiting

  • Icm Val D'Aurelle

    Montpellier, 34298

    William JACOT, 04 67 61 23 39, william.jacot@icm.unicancer.fr

    Recruiting

  • Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly)

    Nancy, 54100

    Laurene GAVOILLE, 03 83 93 50 05, l.gavoille@ilcgroupe.fr

    Not yet recruiting

  • Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann

    Neuilly-sur-Seine, 92200

    Jean-Michel VANNETZEL, Dr, 01 47 59 00 00, dr.vannetzel@gmail.com

    Not yet recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Caroline BAILLEUX, 04 92 03 11 14, caroline.bailleux@nice.unicancer.fr

    Not yet recruiting

  • CHU de Nimes

    Nîmes, 30029

    Frédéric FITENI, Pr, 04 66 68 33 01, frederic.fiteni@chu-nimes.fr

    Not yet recruiting

  • Hôpital Saint-Louis

    Paris, 75010

    Delphine COCHEREAU, 01 42 49 96 13, delphine.cochereau@aphp.fr

    Not yet recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75020

    Laure HIRSCH, 01 44 64 20 37, lhirsch@hopital-dcss.org

    Not yet recruiting

  • Centre Hospitalier de Pau

    Pau, 64046

    Kévin BOURCIER, 05 59 72 67 96, Kevin.BOURCIER@ch-pau.fr

    Not yet recruiting

  • Hopital Privé Des Côtes D'Armor (Hpca) - Cario

    Plérin, 22190

    Jérôme MARTIN-BABAU, 02 96 75 22 16, j.martin@cario-sante.fr

    Not yet recruiting

  • Institut Godinot

    Reims, 51100

    Pauline SOIBINET-OUDOT, 03 26 50 43 83, pauline.soibinet@reims.unicancer.fr

    Recruiting

  • Centre Eugene Marquis

    Rennes

    Sophie LE DU, 02 99 25 29 56, f.ledu@rennes.unicancer.fr

    Recruiting

  • Chp Saint-Grégoire - Groupe Vivalto Sante

    Saint-Grégoire, 35760

    Romuald LE SCODAN, 02 90 09 44 65, rlescodan@vivalto-sante.com

    Not yet recruiting

  • Clinique Sainte-Anne - Gh Saint-Vincent

    Strasbourg, 67000

    Youssef TAZI, 03 88 45 47 00, ytazi@solcrr.org

    Not yet recruiting

  • Hôpitaux Du Léman

    Thonon-les-Bains, 74200

    Fanny POMMERET, 06 08 74 85 11, F-POMMERET@ch-hopitauxduleman.fr

    Not yet recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 054519

    Vincent MASSARD, 03 83 59 84 61, v.massard@nancy.unicancer.fr

    Recruiting

  • Gustave Roussy

    Villejuif

    Joana RIBEIRO, 01 42 11 43 70 ext. +33, joana-mourato.ribeiro@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: 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

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).

Read the detailed description

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).

Being tested
trastuzumab derxutecan
Keywords
HR+, HER2 low, HER2 ultralow, molecular screening, ctDNA, T-DXd, Antibody-drug conjugate, trastuzumab deruxtecan, Breast cancer metastatic
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trastuzumab derxutecanDrug

    T-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).

Study groups in NCT06680596
Study groupRoleWhat they receive
T-DXdExperimentalT-DXd will be administrated as an intra-venous injection of 5.4 mg/kg every three weeks (1 cycle = 21-day treatment).
Receives: Drug: trastuzumab derxutecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    The progression-free survival is the length of time during and after treatment of the disease with T-DXd that a patient lives with the disease but it does not get worse.

    Measured: From first treatment administration to disease progression or death, up to 5 years

Secondary outcomes (6)

  1. Overall survival (OS)

    The overall survival is the length of time from first T-DXd administration that patients enrolled in the study are still alive.

    Measured: From the first T-DXd administration to death due to any cause, up to 5 years

  2. Objective response Rate (ORR)

    The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a T-DXd treatment.

    Measured: From first T-DXd Administration to 6 months after the first administration of treatment, up to 5 years

  3. Duration of response (DoR)

    The time from first documented response (CR or PR) until the date of the first disease progression or death from any cause, whichever occurs first.

    Measured: From the date of first documentation to disease progression or death, up to 5 years

  4. Clinical benefit rate (CBR)

    The clinical benefit risk is defined as the proportion of patients with at least a confirmed CR, PR, or a stable disease for 6 months or more after the first administration of treatment.

    Measured: From first T-DXd Administration to 6 months after the first administration of treatment, up to 5 years

  5. Time to response (TTR)

    The time to response is defined as the time from the first T-DXd administration to the first documentation of CR or PR.

    Measured: From the first T-DXd administration to objective response, up to 5 years

  6. Toxicity during the study

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start30 Jul 2025
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680596
Sponsor's protocol ID
UC-GMP-2402
Other IDs
2024-515349-41-00
Acronym
SAFIR3LibHERty
Status last verified
Oct 2026
First submitted
7 Nov 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab derxutecan in people with Breast Cancer Metastatic and Breast Cancer Stage IV, run by UNICANCER at 40 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François LEGRAND (01 73 79 73 02 ext. +33, safir03libherty@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From first treatment administration to disease progression or death, up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06680596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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