Breast CancersPhase 3OPT-PEMBRONCT06606730
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
A Phase 3 study testing Pembrolizumab and Deescalation in people with Breast Cancers and Triple Negative Breast Cancer (TNBC), run by UNICANCER at 2 sites in 2 countries.
Trial summary
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study. The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancers, Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Pembrolizumab and Deescalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,454 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2025to 1 Jun 2039
- Phase
- Phase 3
- 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-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;
- Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO/CAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;
- Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively);
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- Absence of residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy (Residual ductal carcinoma in situ [DCIS] is allowed);
- Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes) :
- Breast surgery: patients must have undergone either breast-conserving surgery or total mastectomy with histologically negative margins for invasive tumour and DCIS. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
- Lymph node surgery: patients must have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) to evaluate the pathologic nodal status;
- Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy;
- Adequate organ and bone marrow functions. All screening lab tests should be performed within 28 days before randomisation;
- Absolute Neutrophil Count (ANC) ≥ 1,000 /µL
- Platelets ≥ 100,000 /µL
- Hemoglobin ≥ 9 g/dL
- Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN (Patients with Gilbert's disease with a total bilirubin ≤ 2.5 x ULN and direct bilirubin within normal limits are permitted)
- Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 x ULN
- Randomisation must take place no more than 12 weeks after breast surgery. Adjuvant radiotherapy is authorized. If given, as per investigator discretion it can be given concurrently with pembrolizumab;
- Patients must not be pregnant or nursing (for women of childbearing potential only, a negative serum pregnancy test must be obtained within 7 days of Cycle 1 Day 1);
- Women of childbearing potential and male patients must agree to use 1 effective form of contraception and up to 4 months after the last dose of study drugs;
- Patients should be able and willing to comply with study visits and procedures as per protocol;
- Patients must be affiliated to a Social Security System (or equivalent).
Who cannot join
- Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;
- Evidence of recurrent disease following preoperative therapy and surgery;
- Any prior history of (ipsi- or contralateral) invasive breast cancer;
- Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;
- Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;
- History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any component of the product;
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- Medical conditions that require chronic systemic steroids (> 10 mg prednisone or equivalent) or any other form of immunosuppressive medication in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
- Known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis;
- HIV-infected patients on effective anti-retroviral therapy with detectable viral load within 6 months prior to enrollment;
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better;
- Patients unwilling or unable to comply with the medical follow-up required by the trial due to geographic, familial, social, or psychological reasons;
- Persons deprived of their liberty or under protective custody or guardianship;
- Participation in another therapeutic trial within the 30 days prior to randomisation.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc Brussels
Brussels, 1200
François DUHOUX, MD, +3227645435, françois.duhoux@uclouvain.be
France1 site, 1 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Joana MOURATO RIBEIRO, MD, +33 1 42 11 43 70, joana-mourato.ribeiro@gustaveroussy.fr
About this study
Official title: OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.
The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months.
This research will also take into account patients tolerance to treatment and quality of life.
Read the detailed description
Triple-negative breast cancer is a particular type of breast cancer in which the cancer cells do not possess receptors for the proteins estrogen, progesterone, or HER2. The usual treatment for early-stage triple-negative breast cancer consists of chemotherapy and immunotherapy (a treatment (in this case, pembrolizumab) designed to stimulate the body's immune defenses against cancer cells) for 6 months before surgery, followed by a further 6 months of immunotherapy after surgery. Although this sequence is the reference treatment, the addition of an immunotherapy extension after surgery may not bring any additional benefit in patients who have had an excellent response to neoadjuvant treatment (before surgery), demonstrated by tumor disappearance at the time of surgery, and who therefore have a good prognosis.
- Being tested
- Pembrolizumab, Deescalation
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Administration of pembrolizumab for 6 months
DeescalationOther
Patients will be followed up according to standard practice for 4 years
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Administration of pembrolizumab for 6 months Receives: Drug: Pembrolizumab |
| Deescalation | Experimental | Patients will be followed up according to standard practice for 4 years Receives: Other: Deescalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Recurrence-free survival is defined as the time from randomisation to invasive loco-regional or distant recurrence or death from any cause, whichever occurs first.
Measured: From randomization to disease progression or death, up to 8 years.
Secondary outcomes (14)
Acute and late 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, up to 1 year.
Patient reported outcome (PRO)-CTCAE composite score
The PRO-CTCAE composite score is a self-reported questionnaire to assess selected adverse events (bloating, diarrhea, abdominal pain, rash, itching, anorexia, nausea, fatigue, dyspnea, radiation skin reaction, myalgia, arthralgia, pain, and peripheral sensory neuropathy)
Measured: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Quality of life questionnaire - Breast cancer module (QLQ-BR42)
This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR42 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items.
Measured: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
The developed 5-level version of EQ-5D (EQ-5D-5L)
Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS).
The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels (1 = "no problems", 2 = "slight problems", 3 = "moderate problems", 4 = "severe problems", and 5 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (The best health you can image) to 100 (The worst health you can image). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Impact of Cancer Version 2 (IOC v2) Question 11
The Impact of Cancer Version 2 (IOCv2) is a 47-item questionnaire. The question 11 is concerning fear of recurrence.
The item is scored on a five-point scale (1 = "strongly disagree", 2 = "disagree", 3 = "neutral", 4 = "agree", and 5 = "strongly agree"). Higher scores on the positive impact indicate greater positive impacts, while higher scores on the negative impact indicate greater negative impacts.
Measured: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Menstruation recovery rate
Menstruation recovery rate refers to how quickly or how often a patient returns to having regular menstrual periods after experiencing a disruption.
Measured: Throughout the study completion, up to 8 years.
Impact on pregnancy
The impact of the treatment strategy on pregnancy is defined as the number of patient becoming pregnant and the outcomes (healthy birth, miscarriage, stillbirth, preterm birth, and complications) at the end of the pregnancy.
Measured: Throughout the study completion, up to 8 years.
LHRH agonist prescription
Patterns of use of LHRH agonist during adjuvant pembrolizumab treatment.
Measured: Throughout the study completion, up to 8 years.
Invasive breast cancer-free survival (IBCFS)
Invasive breast cancer-free survival (IBCFS) is defined as the time from randomization to invasive ipsilateral or contra-lateral breast tumour recurrence, loco-regional invasive recurrence, distant recurrence, and death from breast cancer, death from non-breast cancer or from an unknown cause.
Measured: From randomization to IBCFS or death, up to 8 years.
Distant relapse free-survival (DRFS)
Distant relapse free-survival (DRFS) is defined as the time from randomization to distant recurrence, death from non-breast cancer or from an unknown cause.
Measured: From randomization to distant recurrence or death, up to 8 years.
Incidence of second primary cancer
Incidence of second primary cancer is defined as the diagnostic of a completely different type of cancer (i.e other than breast)
Measured: From randomization to apparition of a second cancer, up to 8 years.
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, up to 8 years.
Cost-effectiveness analysis of the proposed therapeutic strategy (ISPOR-model)
The economic cost of the pembrolizumab as compared to observation will be evaluated using an International Society for Pharmacoeconomics and Outcomes Research (ISPOR) standard health economic decision model. The cost of pembrolizumab and other concomitant treatment will be analysed based on country specific guidelines together with survival data to represent the clinical pathway for early breast cancer in each country. Results will be expressed in terms of cost assessments, incremental cost-effectiveness ratio and quality of life adjusted life years.
Measured: Throughout the study completion, up to 8 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start23 Jul 2025
- Primary completion1 Jan 2033 (estimated)
- Study completion1 Jun 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joana Mourato Ribiero, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606730
- Sponsor's protocol ID
- UC-BCG-2401
- Other IDs
- 2024-515787-31-00
- Acronym
- OPT-PEMBRO
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab
- ClinicalTrials.gov ID
- NCT06606730
- Acronym / sponsor ID
- OPT-PEMBRO / UC-BCG-2401
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,454 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 1 Jan 2033 (estimated)
- Study completion
- 1 Jun 2039 (estimated)
- First posted
- 23 Sep 2024 (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.
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.
The main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months.
This research will also take into account patients tolerance to treatment and quality of life.
Detailed description
Triple-negative breast cancer is a particular type of breast cancer in which the cancer cells do not possess receptors for the proteins estrogen, progesterone, or HER2. The usual treatment for early-stage triple-negative breast cancer consists of chemotherapy and immunotherapy (a treatment (in this case, pembrolizumab) designed to stimulate the body's immune defenses against cancer cells) for 6 months before surgery, followed by a further 6 months of immunotherapy after surgery. Although this sequence is the reference treatment, the addition of an immunotherapy extension after surgery may not bring any additional benefit in patients who have had an excellent response to neoadjuvant treatment (before surgery), demonstrated by tumor disappearance at the time of surgery, and who therefore have a good prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Drug: PembrolizumabAdministration of pembrolizumab for 6 months |
| Deescalation | Experimental | Other: DeescalationPatients will be followed up according to standard practice for 4 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
- Age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;
- Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO/CAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;
Key exclusion criteria (13 listed)
- Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;
- Evidence of recurrent disease following preoperative therapy and surgery;
- Any prior history of (ipsi- or contralateral) invasive breast cancer;
- Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;
- Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaAdministration of pembrolizumab for 6 months | Drug | Control |
| DeescalationPatients will be followed up according to standard practice for 4 years | Other | Deescalation |
Primary outcome
Recurrence-free survival
Time frame: From randomization to disease progression or death, up to 8 years.
Recurrence-free survival is defined as the time from randomisation to invasive loco-regional or distant recurrence or death from any cause, whichever occurs first.
14 secondary outcomes
Acute and late toxicity during the study
Time frame: Throughout study, up to 1 year.
Patient reported outcome (PRO)-CTCAE composite score
Time frame: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Quality of life questionnaire - Breast cancer module (QLQ-BR42)
Time frame: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
The developed 5-level version of EQ-5D (EQ-5D-5L)
Time frame: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Impact of Cancer Version 2 (IOC v2) Question 11
Time frame: At baseline, 12 weeks, end of treatment, 1 year after end of treatment, 2 years after end of treatment and 3 years after end of treatment
Menstruation recovery rate
Time frame: Throughout the study completion, up to 8 years.
Impact on pregnancy
Time frame: Throughout the study completion, up to 8 years.
LHRH agonist prescription
Time frame: Throughout the study completion, up to 8 years.
Invasive breast cancer-free survival (IBCFS)
Time frame: From randomization to IBCFS or death, up to 8 years.
Distant relapse free-survival (DRFS)
Time frame: From randomization to distant recurrence or death, up to 8 years.
Incidence of second primary cancer
Time frame: From randomization to apparition of a second cancer, up to 8 years.
Overall survival (OS)
Time frame: From randomization to death, up to 8 years.
Cost-effectiveness analysis of the proposed therapeutic strategy (ISPOR-model)
Time frame: Throughout the study completion, up to 8 years.
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 23 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Joana Mourato Ribiero principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pembrolizumab and Deescalation in people with Breast Cancers and Triple Negative Breast Cancer (TNBC), run by UNICANCER at 2 sites in 2 countries.
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 23 inclusion and 13 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 23 Jul 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 Belgium, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sonia Mardinian (+33 6 98 54 96 60, s-mardinian@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: From randomization to disease progression or death, up to 8 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 23 Jul 2026.