ClinicalTrials.gg
RecruitingNCT06680596SAFIR3LibHERtyUpdated Oct 29, 2026

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

A Phase 2 interventional study of trastuzumab derxutecan in Breast Cancer Metastatic and Breast Cancer Stage IV, sponsored by UNICANCER. Recruiting at 40 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by UNICANCER · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Updated Oct 29, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Breast Cancer Metastatic
  • Breast Cancer Stage IV

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Keywords

  • HR+
  • HER2 low
  • HER2 ultralow
  • molecular screening
  • ctDNA
  • T-DXd
  • Antibody-drug conjugate
  • trastuzumab deruxtecan
  • Breast cancer metastatic
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

UNICANCER is the lead sponsor of 219 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

SCREENING PHASE_________________________________________________________

Inclusion criteria

  1. Patient must have signed the written 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 and eligible to for subsequent histological or cytological confirmation,
    • Is 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 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 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 (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 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 , has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at baseline
  7. Patient has a history of severe 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. (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:

    • (ANC) ≥1500/mm³,
    • count ≥100,000/mm³,
    • ≥9.0 g/dl,
    • Serum creatinine ≤1.5 × (ULN) or ≥30 mL/min,
    • Serum albumin ≥2.5 g/dL,
    • Total ≤1.5 × ULN (\<3 ULN if Gilbert's disease),
    • In absence of liver metastases, (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 /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 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 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 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, pulmonary disease, clinically significant neurological disorder, chronic pancreatitis, chronic active infection with virus, virus, or , 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 ( Class II to IV),
    • Patient with a interval (QTc) prolongation to >470 ms (females) or >450 ms (males) based on average of the screening triplicate12-lead ,
    • 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 (COPD), restrictive lung disease, pleural effusion, etc.), and any , 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 drugs. Concomitant use of strong 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 : 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 ) 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.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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).

    Drug: trastuzumab derxutecan

Interventions

  • Drugtrastuzumab derxutecan

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

This study also gives Trastuzumab deruxtecan. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Throughout study completion, up to 5 years

07

Study locations

12 of 40 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Aug 2028, 36 months after the start.

Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's planned 36 months is below that.

Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2024
First posted
Nov 8, 2024
StartActual
Jul 30, 2025
Primary completionEst.
Aug 1, 2028
CompletionEst.
Aug 1, 2029
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Recruiting
changed Oct 29, 2026
Sites
2 sites added. 38 sites changed recruiting status (26 now not yet recruiting, 12 now recruiting)
Show 38 sites
  • Chu Amiens Picardie · Amiens, Franceno status→Not yet recruiting
  • Clinique de L'Europe Amiens - Cthe · Amiens, Franceno status→Not yet recruiting
  • Centre Hospitalier D'Auxerre · Auxerre, Franceno status→Not yet recruiting
  • Sainte Catherine Institut Du Cancer Avignon Provence · Avignon, Franceno status→Recruiting
  • Centre Hospitalier de la Côte Basque · Bayonne, Franceno status→Not yet recruiting
  • Centre Hospitalier de Beauvais · Beauvais, Franceno status→Recruiting
  • Hôpital Simone Veil de Blois · Blois, Franceno status→Not yet recruiting
  • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, Franceno status→Not yet recruiting
  • Chu de Brest - Hôpital Cavale Blanche · Brest, Franceno status→Recruiting
  • Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante · Brest, Franceno status→Not yet recruiting
  • Centre Hospitalier William Morey · Chalon-sur-Saône, Franceno status→Recruiting
  • Centre Hospitalier de Cholet · Cholet, Franceno status→Recruiting
  • Pôle Santé République (Elsan) · Clermont-Ferrand, Franceno status→Not yet recruiting
  • Centre Jean Perrin · Clermont-Ferrand, Franceno status→Recruiting
  • Centre Hospitalier Alpes Léman · Contamine-sur-Arve, Franceno status→Not yet recruiting
  • Clinique de Flandre · Coudekerque-Branche, Franceno status→Not yet recruiting
  • Chi Fréjus-Saint-Raphaël · Fréjus, Franceno status→Not yet recruiting
  • Chd Vendée · La Roche-sur-Yon, Franceno status→Not yet recruiting
  • Centre Léon Bérard · Lyon, Franceno status→Recruiting
  • Hopital Prive Jean Mermoz · Lyon, Franceno status→Not yet recruiting
  • Clinique de La Sauvegarde · Lyon, Franceno status→Not yet recruiting
  • Institut Paoli Calmettes · Marseille, Franceno status→Not yet recruiting
  • Icm Val D'Aurelle · Montpellier, Franceno status→Recruiting
  • Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly) · Nancy, Franceno status→Not yet recruiting
  • Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann · Neuilly-sur-Seine, Franceno status→Not yet recruiting
  • Centre Antoine Lacassagne · Nice, Franceno status→Not yet recruiting
  • CHU de Nimes · Nîmes, Franceno status→Not yet recruiting
  • Hôpital Saint-Louis · Paris, Franceno status→Not yet recruiting
  • Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, Franceno status→Not yet recruiting
  • Centre Hospitalier de Pau · Pau, Franceno status→Not yet recruiting
  • …and 8 more on the registry record
Show 2 added (2 France)
  • Institut de Cancerologie Des Hauts de France - Centre Pierre Curie · Beuvry, France
  • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, France
Oct 29, 2026
Contact
Study contact now listed: added s•••@unicancer.fr · •••7302; added m•••@unicancer.fr. See the current contact
Oct 29, 2026
Site contacts
Changed at 38 sites. See the sites
Show 38 sites
  • Chu Amiens Picardie · Amiens, FranceContact added m•••@chu-amiens.fr · •••5499
  • Clinique de L'Europe Amiens - Cthe · Amiens, FranceContact added d•••@cthe-amiens.fr · •••5343
  • Centre Hospitalier D'Auxerre · Auxerre, FranceContact added a•••@ch-auxerre.fr · •••4765
  • Sainte Catherine Institut Du Cancer Avignon Provence · Avignon, FranceContact added b•••@isc84.org · •••6397
  • Centre Hospitalier de la Côte Basque · Bayonne, FranceContact added t•••@ch-cotebasque.fr · •••8127
  • Centre Hospitalier de Beauvais · Beauvais, FranceContact added h•••@ch-beauvais.fr · •••2123
  • Hôpital Simone Veil de Blois · Blois, FranceContact added a•••@ch-blois.fr · •••6405
  • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, FranceContact added a•••@ch-boulogne.fr · •••3013
  • Chu de Brest - Hôpital Cavale Blanche · Brest, FranceContact added l•••@chu-brest.fr · •••3395
  • Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante · Brest, FranceContact added m•••@oncologie-brest.fr · •••3007
  • Centre Hospitalier William Morey · Chalon-sur-Saône, FranceContact added t•••@ch-chalon71.fr · •••6688
  • Centre Hospitalier de Cholet · Cholet, FranceContact added v•••@ch-cholet.fr · •••6231
  • Pôle Santé République (Elsan) · Clermont-Ferrand, FranceContact added p•••@polesanterepublique.com · •••4390
  • Centre Jean Perrin · Clermont-Ferrand, FranceContact added x•••@clermont.unicancer.fr · •••8005
  • Centre Hospitalier Alpes Léman · Contamine-sur-Arve, FranceContact added m•••@ch-alpes-leman.fr · •••2270
  • Clinique de Flandre · Coudekerque-Branche, FranceContact added j•••@iadonco.org · •••1439
  • Chi Fréjus-Saint-Raphaël · Fréjus, FranceContact added p•••@chi-fsr.fr · •••8783Contact added p•••@chi-fsr.fr
  • Chd Vendée · La Roche-sur-Yon, FranceContact added c•••@ght85.fr · •••6173
  • Centre Léon Bérard · Lyon, FranceContact added t•••@lyon.unicancer.fr · •••3654
  • Hopital Prive Jean Mermoz · Lyon, FranceContact added o•••@gmail.com · •••8725
  • Clinique de La Sauvegarde · Lyon, FranceContact added d•••@gmail.com · •••1820
  • Institut Paoli Calmettes · Marseille, FranceContact added T•••@ipc.unicancer.fr · •••3333
  • Icm Val D'Aurelle · Montpellier, FranceContact added w•••@icm.unicancer.fr · •••2339
  • Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly) · Nancy, FranceContact added l•••@ilcgroupe.fr · •••5005
  • Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann · Neuilly-sur-Seine, FranceContact added d•••@gmail.com · •••0000
  • Centre Antoine Lacassagne · Nice, FranceContact added c•••@nice.unicancer.fr · •••1114
  • CHU de Nimes · Nîmes, FranceContact added f•••@chu-nimes.fr · •••3301
  • Hôpital Saint-Louis · Paris, FranceContact added d•••@aphp.fr · •••9613
  • Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, FranceContact added l•••@hopital-dcss.org · •••2037
  • Centre Hospitalier de Pau · Pau, FranceContact added K•••@ch-pau.fr · •••6796
  • …and 8 more sites
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Enrolling by invitation→Recruiting
    2 sites added. 38 sites changed recruiting status (26 now not yet recruiting, 12 now recruiting)
    Show 38 sites
    • Chu Amiens Picardie · Amiens, Franceno status→Not yet recruiting
    • Clinique de L'Europe Amiens - Cthe · Amiens, Franceno status→Not yet recruiting
    • Centre Hospitalier D'Auxerre · Auxerre, Franceno status→Not yet recruiting
    • Sainte Catherine Institut Du Cancer Avignon Provence · Avignon, Franceno status→Recruiting
    • Centre Hospitalier de la Côte Basque · Bayonne, Franceno status→Not yet recruiting
    • Centre Hospitalier de Beauvais · Beauvais, Franceno status→Recruiting
    • Hôpital Simone Veil de Blois · Blois, Franceno status→Not yet recruiting
    • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, Franceno status→Not yet recruiting
    • Chu de Brest - Hôpital Cavale Blanche · Brest, Franceno status→Recruiting
    • Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante · Brest, Franceno status→Not yet recruiting
    • Centre Hospitalier William Morey · Chalon-sur-Saône, Franceno status→Recruiting
    • Centre Hospitalier de Cholet · Cholet, Franceno status→Recruiting
    • Pôle Santé République (Elsan) · Clermont-Ferrand, Franceno status→Not yet recruiting
    • Centre Jean Perrin · Clermont-Ferrand, Franceno status→Recruiting
    • Centre Hospitalier Alpes Léman · Contamine-sur-Arve, Franceno status→Not yet recruiting
    • Clinique de Flandre · Coudekerque-Branche, Franceno status→Not yet recruiting
    • Chi Fréjus-Saint-Raphaël · Fréjus, Franceno status→Not yet recruiting
    • Chd Vendée · La Roche-sur-Yon, Franceno status→Not yet recruiting
    • Centre Léon Bérard · Lyon, Franceno status→Recruiting
    • Hopital Prive Jean Mermoz · Lyon, Franceno status→Not yet recruiting
    • Clinique de La Sauvegarde · Lyon, Franceno status→Not yet recruiting
    • Institut Paoli Calmettes · Marseille, Franceno status→Not yet recruiting
    • Icm Val D'Aurelle · Montpellier, Franceno status→Recruiting
    • Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly) · Nancy, Franceno status→Not yet recruiting
    • Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann · Neuilly-sur-Seine, Franceno status→Not yet recruiting
    • Centre Antoine Lacassagne · Nice, Franceno status→Not yet recruiting
    • CHU de Nimes · Nîmes, Franceno status→Not yet recruiting
    • Hôpital Saint-Louis · Paris, Franceno status→Not yet recruiting
    • Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, Franceno status→Not yet recruiting
    • Centre Hospitalier de Pau · Pau, Franceno status→Not yet recruiting
    • …and 8 more on the registry record
    Show 2 added (2 France)
    • Institut de Cancerologie Des Hauts de France - Centre Pierre Curie · Beuvry, France
    • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, France
    Contact Study contact now listed: added s•••@unicancer.fr · •••7302; added m•••@unicancer.fr. See the current contact
    Site contacts Changed at 38 sites. See the sites
    Show 38 sites
    • Chu Amiens Picardie · Amiens, FranceContact added m•••@chu-amiens.fr · •••5499
    • Clinique de L'Europe Amiens - Cthe · Amiens, FranceContact added d•••@cthe-amiens.fr · •••5343
    • Centre Hospitalier D'Auxerre · Auxerre, FranceContact added a•••@ch-auxerre.fr · •••4765
    • Sainte Catherine Institut Du Cancer Avignon Provence · Avignon, FranceContact added b•••@isc84.org · •••6397
    • Centre Hospitalier de la Côte Basque · Bayonne, FranceContact added t•••@ch-cotebasque.fr · •••8127
    • Centre Hospitalier de Beauvais · Beauvais, FranceContact added h•••@ch-beauvais.fr · •••2123
    • Hôpital Simone Veil de Blois · Blois, FranceContact added a•••@ch-blois.fr · •••6405
    • Centre Hospitalier de Boulogne-Sur-Mer · Boulogne-sur-Mer, FranceContact added a•••@ch-boulogne.fr · •••3013
    • Chu de Brest - Hôpital Cavale Blanche · Brest, FranceContact added l•••@chu-brest.fr · •••3395
    • Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante · Brest, FranceContact added m•••@oncologie-brest.fr · •••3007
    • Centre Hospitalier William Morey · Chalon-sur-Saône, FranceContact added t•••@ch-chalon71.fr · •••6688
    • Centre Hospitalier de Cholet · Cholet, FranceContact added v•••@ch-cholet.fr · •••6231
    • Pôle Santé République (Elsan) · Clermont-Ferrand, FranceContact added p•••@polesanterepublique.com · •••4390
    • Centre Jean Perrin · Clermont-Ferrand, FranceContact added x•••@clermont.unicancer.fr · •••8005
    • Centre Hospitalier Alpes Léman · Contamine-sur-Arve, FranceContact added m•••@ch-alpes-leman.fr · •••2270
    • Clinique de Flandre · Coudekerque-Branche, FranceContact added j•••@iadonco.org · •••1439
    • Chi Fréjus-Saint-Raphaël · Fréjus, FranceContact added p•••@chi-fsr.fr · •••8783Contact added p•••@chi-fsr.fr
    • Chd Vendée · La Roche-sur-Yon, FranceContact added c•••@ght85.fr · •••6173
    • Centre Léon Bérard · Lyon, FranceContact added t•••@lyon.unicancer.fr · •••3654
    • Hopital Prive Jean Mermoz · Lyon, FranceContact added o•••@gmail.com · •••8725
    • Clinique de La Sauvegarde · Lyon, FranceContact added d•••@gmail.com · •••1820
    • Institut Paoli Calmettes · Marseille, FranceContact added T•••@ipc.unicancer.fr · •••3333
    • Icm Val D'Aurelle · Montpellier, FranceContact added w•••@icm.unicancer.fr · •••2339
    • Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly) · Nancy, FranceContact added l•••@ilcgroupe.fr · •••5005
    • Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann · Neuilly-sur-Seine, FranceContact added d•••@gmail.com · •••0000
    • Centre Antoine Lacassagne · Nice, FranceContact added c•••@nice.unicancer.fr · •••1114
    • CHU de Nimes · Nîmes, FranceContact added f•••@chu-nimes.fr · •••3301
    • Hôpital Saint-Louis · Paris, FranceContact added d•••@aphp.fr · •••9613
    • Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, FranceContact added l•••@hopital-dcss.org · •••2037
    • Centre Hospitalier de Pau · Pau, FranceContact added K•••@ch-pau.fr · •••6796
    • …and 8 more sites
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06680596
Lead sponsor
UNICANCER
Collaborators
AstraZeneca, Breast Cancer Research Foundation
Responsible party
Sponsor
First posted
Nov 8, 2024
Start date
Jul 30, 2025
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Oct 29, 2026

Study contacts

François LEGRAND
Contact
safir03libherty@unicancer.fr
01 73 79 73 02 ext. +33
Marta JIMENEZ
Contact
m-jimenez@unicancer.fr
Fabrice ANDRE, MD
principal investigator · Gustave Roussy, Cancer Campus, Grand Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Trastuzumab deruxtecan

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