Triple Negative Breast NeoplasmsPhase 2ALTERNCT07151586
Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer
A Phase 2 study testing Sacituzumab Govitecan / Trastuzumab Deruxtecan in people with Triple Negative Breast Neoplasms and Neoplasm Metastasis, run by UNICANCER at 2 sites in France.
Trial summary
This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Neoplasms, Neoplasm Metastasis, HER 2 Low-expressing Breast Cancer
- What is being tested?
- Sacituzumab Govitecan / Trastuzumab Deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2026to Oct 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 a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his/her written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)
- Men or women ≥ 18 years of age
- Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:
- HER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ / in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site
- Estrogen receptor (ER) expression <10% and progesterone receptor (PR) expression <10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)
- Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication
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- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Women of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men.
- A woman is considered to be of childbearing potential if she is not postmenopausal or has not undergone hysterectomy. Postmenopausal is defined as any of the following:
- Age ≥ 60 years Age < 60 years and ≥ 12 continuous months of amenorrhea with no identified cause other than menopause Surgical sterilization (bilateral oophorectomy)
- Adequate organ and bone marrow function within 28 days before enrollment. The most recent results available must be used for all parameters below:
- Hemoglobin ≥ 9 g/dL. Red blood cell transfusion is not allowed within 1 week prior to screening assessment
- Absolute neutrophil count (ANC) ≥ 1,500/mm³. Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment
- Platelet count ≥ 100,000/mm³. Platelet transfusion is not allowed within 1 week prior to registration
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases, or < 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or < 5 × ULN in patients with liver metastasis
- Serum albumin ≥ 2.5 g/dL
- Creatinine clearance (CrCl) ≥ 30 mL/min, calculated using the Cockcroft-Gault equation: CrCl (mL/min) = [(140 - age in years) × weight in kg] / [72 × serum creatinine in mg/dL] (× 0.85 for females)
- Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy
- Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization
- Affiliated to the French Social Security System (or equivalent)
- Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
Who cannot join
- Patient previously treated with any ADC targeting HER2 or TROP2
- Patient with uncontrolled or significant cardiovascular disease
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study
- Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients
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- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations
- Patients with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment are not eligible
- Patients enrolled in another therapeutic trial within 30 days of inclusion
- Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment
- Person deprived of their liberty or under protective custody or guardianship
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandre TASSIN DE NONNEVILLE contact
France2 sites
institut Paoli calmette
Marseille, 13009
Alexandre Alexandre TASSIN DE NONNEVILLE, +33491223333, denonnevillea@ipc.unicancer.fr
Gustave Roussy
Villejuif, 94800
Chayma BOUSRIH, +33142114370, chayma.bousrih@gustaveroussy.fr
About this study
Official title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer
This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.
The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?
Read the detailed description
Patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) have poor survival outcomes
Among mTNBC, about 40% of tumors have a low expression of HER2 (HER2-low; defined as IHC 2+/ISH or IHC 1+). Two antibody-drug conjugates (ADCs) have been approved for HER2-low mTNBC: sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) that target TROP2 and HER2 at the tumor cell surface, respectively. Each of these ADCs, used as monotherapy, outperformed conventional chemotherapy according to the ASCENT and DESTINY-Breast 04 trials and thereby have become the new second or third line standard of care for HER2-low mTNBC. However, as with other types of treatments, resistance is inescapable mostly due to intra-tumor heterogeneity. In the case of ADCs, resistance mechanisms involve changes in tumor antigen expression, ADC intracellular uptake and processing, and efflux of the ADC cytotoxic payload. Consequently, SG and T-DXd are used sequentially after progression even though the most effective sequence has so far been scarcely investigated and remains to be established
The ASCENT trial was designed to compare the efficacy of SG with chemotherapy in patients with mTNBC and reported significantly greater progression-free and overall survival compared with the physician's choice of chemotherapy. On the other hand, the DESTINY-Breast-04 compared the efficacy of T-DXd with chemotherapy but included just 63 patients with HER2-low mTNBC. Despite a significantly longer progression-free and overall survival were observed compared with the physician's choice of chemotherapy the efficacy analysis of T-DXd in this subpopulation was not a prespecified endpoint of the trial. Even though, collectively these results have contributed to a treatment paradigm shift for mTNBC, the superiority to chemotherapy can only be formally claimed for SG in mTNBC patients and for T-DXd in HER2-low metastatic breast cancer patients
We hypothesize that an upfront alternating SG and T-DXd regimen would have a greater antitumor effect compared with their prescription at progression while limiting the emergence of drug resistance. Hence, the ALTER trial aims to compare the efficacy and safety of an upfront alternating SG and T-DXd regimen with SG alone in HER2-low mTNBC patients
- Being tested
- Sacituzumab Govitecan / Trastuzumab Deruxtecan
- Keywords
- Antibody-drug conjugates, HER2-low, Triple Negative Breast Cancer, Locally Advanced Breast Cancer, HER2-negative, Metastatic Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Govitecan / Trastuzumab DeruxtecanDrug
Also called Trodelvy, Enhertu
Sacituzumab govitecan is administered intravenously at a dose of 10 mg/kg on Day 1 and Day 8 of each 3-week cycle. In this study, patients receive two cycles of sacituzumab govitecan followed by two cycles of trastuzumab deruxtecan, alternating throughout the study.
Trastuzumab deruxtecan is administered intravenously at a dose of 5.4 mg/kg on Day 1 of each 3-week cycle. In this study, patients receive two cycles of trastuzumab deruxtecan followed by two cycles of sacituzumab govitecan, alternating throughout the study.
Both Treatment are continued until disease progression as defined by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab-Govitecan and Trastuzumab-deruxtecan in alternating shema | Experimental | Patients will receive either SG and T-DXd in an upfront alternating schema: two cycles of SG, followed by two cycles of T-DXd, then two cycles of SG, and so on, until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study. Receives: Drug: Sacituzumab Govitecan / Trastuzumab Deruxtecan |
| Sacituzumab-Govitecan alone | Active comparator | Patient will receive Sacituzumab-Govitecan 1(monotherapy) until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study Receives: Drug: Sacituzumab Govitecan / Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive
Measured: From randomization to death from any cause, up to 4 years.
Secondary outcomes (6)
Clinical Benefit Rate (CBR)
Clinical Benefit Rate is defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD)for at least 24 weeks, as assessed by RECIST 1.1
Measured: Time from randomization to disease progression, up to 4 years.
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) as assessed by RECIST 1.1
Measured: Time from randomization to disease progression, up to 4 years.
Progression-free survival (PFS),
The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Measured: From randomization to disease progression or death, up to 4 years.
Quality-Adjusted progression free survival (QA-PFS)
Quality-Adjusted progression free survival is calculated as the product of the progression free survival function and the overall health utility index EQ-5D-5L.
Measured: From randomization to disease progression or death, up to 4 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), graded per NCI-CTCAE v5.0. The proportion of patients with treatment discontinuations, interruptions, or dose reductions due to adverse events will also be reported
Measured: From first dose through 30 days after the last dose of study treatment
Quality of Life questionnaire - EORTC QLQ-C30
Mean change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) score at Week 24. The QLQ-C30 is a 30-item questionnaire scored according to the EORTC scoring manual on 0-100 scales; higher GHS/QoL scores indicate better quality of life.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startSep 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre TASSIN DE NONNEVILLE, Study chair, Institut Paoli-CalmettesFrançois BERTUCCI, Study chair, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151586
- Sponsor's protocol ID
- UC-BCG-2503
- Other IDs
- 2025-521909-40-00, 2025
- Acronym
- ALTER
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07151586
- Acronym / sponsor ID
- ALTER / UC-BCG-2503
- Keywords
- Antibody-drug conjugates, HER2-low, Triple Negative Breast Cancer, Locally Advanced Breast Cancer, HER2-negative, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.
The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?
Detailed description
Patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) have poor survival outcomes
Among mTNBC, about 40% of tumors have a low expression of HER2 (HER2-low; defined as IHC 2+/ISH or IHC 1+). Two antibody-drug conjugates (ADCs) have been approved for HER2-low mTNBC: sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) that target TROP2 and HER2 at the tumor cell surface, respectively. Each of these ADCs, used as monotherapy, outperformed conventional chemotherapy according to the ASCENT and DESTINY-Breast 04 trials and thereby have become the new second or third line standard of care for HER2-low mTNBC. However, as with other types of treatments, resistance is inescapable mostly due to intra-tumor heterogeneity. In the case of ADCs, resistance mechanisms involve changes in tumor antigen expression, ADC intracellular uptake and processing, and efflux of the ADC cytotoxic payload. Consequently, SG and T-DXd are used sequentially after progression even though the most effective sequence has so far been scarcely investigated and remains to be established
The ASCENT trial was designed to compare the efficacy of SG with chemotherapy in patients with mTNBC and reported significantly greater progression-free and overall survival compared with the physician's choice of chemotherapy. On the other hand, the DESTINY-Breast-04 compared the efficacy of T-DXd with chemotherapy but included just 63 patients with HER2-low mTNBC. Despite a significantly longer progression-free and overall survival were observed compared with the physician's choice of chemotherapy the efficacy analysis of T-DXd in this subpopulation was not a prespecified endpoint of the trial. Even though, collectively these results have contributed to a treatment paradigm shift for mTNBC, the superiority to chemotherapy can only be formally claimed for SG in mTNBC patients and for T-DXd in HER2-low metastatic breast cancer patients
We hypothesize that an upfront alternating SG and T-DXd regimen would have a greater antitumor effect compared with their prescription at progression while limiting the emergence of drug resistance. Hence, the ALTER trial aims to compare the efficacy and safety of an upfront alternating SG and T-DXd regimen with SG alone in HER2-low mTNBC patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab-Govitecan and Trastuzumab-deruxtecan in alternating shema | Experimental | Drug: Sacituzumab Govitecan / Trastuzumab DeruxtecanPatients will receive either SG and T-DXd in an upfront alternating schema: two cycles of SG, followed by two cycles of T-DXd, then two cycles of SG, and so on, until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study. |
| Sacituzumab-Govitecan alone | Active comparator | Drug: Sacituzumab Govitecan / Trastuzumab DeruxtecanPatient will receive Sacituzumab-Govitecan 1(monotherapy) until RECIST 1.1-defined disease progression, unless there is unacceptable toxicity, withdrawal of consent or end of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his/her written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)
- Men or women ≥ 18 years of age
- Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:
- HER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ / in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site
- Estrogen receptor (ER) expression <10% and progesterone receptor (PR) expression <10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)
Key exclusion criteria (12 listed)
- Patient previously treated with any ADC targeting HER2 or TROP2
- Patient with uncontrolled or significant cardiovascular disease
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
- Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Govitecan / Trastuzumab DeruxtecanAlso: Trodelvy, EnhertuSacituzumab govitecan is administered intravenously at a dose of 10 mg/kg on Day 1 and Day 8 of each 3-week cycle. In this study, patients receive two cycles of sacituzumab govitecan followed by two cycles of trastuzumab deruxtecan, alternating throughout the study. Trastuzumab deruxtecan is administered intravenously at a dose of 5.4 mg/kg on Day 1 of each 3-week cycle. In this study, patients receive two cycles of trastuzumab deruxtecan followed by two cycles of sacituzumab govitecan, alternating throughout the study. Both Treatment are continued until disease progression as defined by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or the end of the study. | Drug | Sacituzumab-Govitecan alone, Sacituzumab-Govitecan and Trastuzumab-deruxtecan in alternating shema |
Primary outcome
Overall survival (OS)
Time frame: From randomization to death from any cause, up to 4 years.
The overall survival is the length of time from randomization that patients enrolled in the study are still alive
6 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: Time from randomization to disease progression, up to 4 years.
Objective response rate (ORR)
Time frame: Time from randomization to disease progression, up to 4 years.
Progression-free survival (PFS),
Time frame: From randomization to disease progression or death, up to 4 years.
Quality-Adjusted progression free survival (QA-PFS)
Time frame: From randomization to disease progression or death, up to 4 years.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through 30 days after the last dose of study treatment
Quality of Life questionnaire - EORTC QLQ-C30
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre TASSIN DE NONNEVILLE contact
Alexandre TASSIN DE NONNEVILLE study chair
Institut Paoli-Calmettes
François BERTUCCI study chair
Institut Paoli-Calmettes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan / Trastuzumab Deruxtecan in people with Triple Negative Breast Neoplasms and Neoplasm Metastasis, run by UNICANCER at 2 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 22 inclusion and 12 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 GERALD BAGOE (+337714415 82, g-bagoe@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From randomization to death from any cause, up to 4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.