Metastatic Breast Cancer With a Isolated Brain ProgressionPhase 2InTTercePTNCT05041842
Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer
A Phase 2 study testing Tucatinib, Pertuzumab and Trastuzumab in people with Metastatic Breast Cancer With a Isolated Brain Progression, run by UNICANCER at 16 sites in France.
Trial summary
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer With a Isolated Brain Progression
- What is being tested?
- Tucatinib, Pertuzumab and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 16 sitesFrance
- Study dates
- 17 Dec 2021to 30 Apr 2026
- 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
- Male or female, Age ≥18;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1;
- Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology;
- Documented isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) under pertuzumab and trastuzumab treatment (with or without taxane) for metastatic disease (There is no limit to the number and size of brain metastasis);
- Complete local treatment of brain progression (Surgery and/or radiation therapy) should have been completed no more than 12 weeks before inclusion and there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator;
- Able to undergo MRI scanning of the brain;
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- Normal renal function: creatinine <1.5 x upper limit of normal (ULN);
- Adequate liver function: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases);
- Normal hematological function: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL;
- Adequate cardiac functions, including:
- 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- QT/Corrected QT interval (QTcF) ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kalemia
- Left ventricular ejection fraction (LVEF) ≥50%
- No history of Torsades de Pointes or other symptomatic QTc abnormality
- Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 5.0 Grade 1 or to baseline (except alopecia or others toxicities not considered a safety risk for the patient at investigator's discretion);
- Stable dose of steroids at the time of enrolment;
- Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion;
- Woman 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/therapy (association of trastuzumab, pertuzumab +/- tucatinib). Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive;
- Patient must have signed a written informed consent form prior to any trial specific procedures. 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;
- Patients affiliated to the social security system (or equivalent);
- Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up.
Who cannot join
- Radiologic extra-cranial progression under pertuzumab and trastuzumab treatment, at the time of enrolment. The systemic disease must be stable or responding at the time of enrolment;
- Proven leptomeningeal disease;
- Any progressive brain lesion between the brain local treatment completion and the enrolment;
- Poorly controlled seizures (more than 1/week);
- Clinically significant cardiopulmonary disease;
- Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A substrates should be avoided one week before enrollment and during study treatment
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- Previous treatment with a tyrosine kinase inhibitor;
- Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease;
- Positive for human immunodeficiency virus (HIV);
- Known prior severe hypersensitivity to tucatinib or compounds chemically or/and biologically similar or any component in its formulation;
- History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 years;
- Pregnant women or women who are breast-feeding;
- Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications;
- Person deprived of their liberty or under protective custody or guardianship or unable to give informed consent;
- Participation in another therapeutic trial within the 30 days prior to tucatinib treatment initiation.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers
Institut Bergonié
Bordeaux
Centre Francois Baclesse
Caen
Centre Georges François Leclerc
Dijon
Clinique Victor Hugo
Le Mans, 72000
Centre Leon Berard
Lyon
Hôpital privé Jean Mermoz
Lyon
Institut du cancer de Montpellier
Montpellier, 34090
Centre Antoine Lacassagne
Nice
CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi
Plérin
Centre Hospitalier Annecy Genevois
Pringy
Institut Jean Godinot
Reims
Centre Henri Becquerel
Rouen
Institut Claudius Regaud
Toulouse
Centre Hospitalier Universitaire de Tours
Tours
Gustave Roussy
Villejuif
About this study
Official title: Treatment With Tucatinib in Addition to Pertuzumab and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer After Local Therapy of Isolated Brain Progression
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.
These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.
The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.
Read the detailed description
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. More than a third of patients with HER2-positive breast cancer develop brain metastases during the course of the disease. For patients with isolated brain progression, local treatment is recommended whenever possible (stereotaxic radiosurgery and / or surgery) as well as the continuation of systemic treatment previously initiated even if the evidence of a benefit is weak.
After local treatment these patients will have a higher risk of progression (cerebral and systemic). Therefore, the question of whether systemic treatment should be continued or changed remains an open question.
In a pooled analysis of two phase 1b studies, patients who continued systemic treatment with tucatinib (in combination with T-DM1 or with trastuzumab and capecitabine) after treatment directed to the central nervous system demonstrated a better prognosis than that of patients who stopped tucatinib.
The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with HER2-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.
These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.
We anticipate that adding tucatinib to the trastuzumab / pertuzumab regimen will control brain metastases, prolong progression-free survival, and improve patient quality of life.
The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.
- Being tested
- Tucatinib, Pertuzumab, Trastuzumab, Hormone therapy, Pertuzumab/ Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
300 mg orally twice daily
PertuzumabDrug
Also called Perjeta®
Initial loading: 840 mg Maintenance: 420 mg, 3-weekly
TrastuzumabDrug
Also called Herceptin® or Biosimilar
Intravenous formulation :
Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly
Subcutaneous formulation:
600 mg (fixed dose regardless of patient's body weight), 3-weekly
Hormone therapyDrug
Anastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection)
Pertuzumab/ TrastuzumabDrug
Also called Phesgo®
Initial loading:
1200 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight)
Maintenance:
600 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight), 3-weekly
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib plus systemic treatment with or without hormone therapy | Experimental | Addition of tucatinib to the systemic treatment (pertuzumab and trastuzumab) with or without hormone therapy. Receives: Drug: Tucatinib; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Hormone therapy; Drug: Pertuzumab/ Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The progression-free survival is defined as the proportion of patients with an objective tumor progression by imaging, or death from any cause, whichever occurs first at 6 months from inclusion. Progression will be determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in case of lesions identified at baseline. For patients without any evidence of evidence at inclusion, the progression will be defined as an appearance of a new lesion (measurable or not measurable).
Measured: 6 months
Secondary outcomes (4)
Overall Survival
Overall Survival is defined as the time interval between the date of inclusion in the study and the date of death (all causes). Patients not known to have died at the time of analysis will be censored at the last recorded date on which the patient was known to be alive
Measured: Throughout study completion, up to 18 months
Brain Progression-Free Survival
Brain Progression-Free Survival is defined as the time interval between the date of inclusion in the study and the date of documented progression of the brain metastases. Tumor progression will be evaluated according to RECIST v1.1, as determined by investigator assessment, or as the appearance of a lesion for patients in complete response (CR) at the brain level at the inclusion. Patients who have not progressed at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
Measured: Throughout study completion, up to 18 months
Overall brain metastasis response
In patients who are not in CR at the brain level after local treatment: Overall brain metastasis response is defined as the best overall response of the brain metastases during the study. Brain metastases response will be evaluated according to RECIST v1.1, as determined by investigator assessment.
Measured: Throughout study completion, up to 18 months
Incidence of treatment-emergent Adverse Events
Adverse Events will be graded according to National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE) v5.0
Measured: Throughout study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start17 Dec 2021
- Primary completion30 Apr 2025
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer With a Isolated Brain ProgressionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients treated with pertuzumab and trastuzumab for metastatic breast cancer who will develop an isolated brain relapse treated with local treatment will receive tucatinib in addition to pertuzumab and trastuzumab. Tucatinib will be taken orally 300 mg twice a day, pertuzumab (420 mg) and trastuzumab (6 mg/kg) will be taken every 3 weeks.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., ARCAGY/ GINECO GROUP
- Responsible party
- Sponsor
- Investigators
- Thomas Bachelot, MD, Principal investigator, Centre Leon BerardAnne-Claire Hardy-Bessard, MD, Principal investigator, Centre Armoricain d'Oncologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041842
- Sponsor's protocol ID
- UC-BCG-2011
- Other IDs
- 2020-005735-79
- Acronym
- InTTercePT
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2021
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Tucatinib in Addition to Pertuzumab and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer After Local Therapy of Isolated Brain Progression
- ClinicalTrials.gov ID
- NCT05041842
- Acronym / sponsor ID
- InTTercePT / UC-BCG-2011
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- Seagen Inc., ARCAGY/ GINECO GROUP
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 13 Sep 2021 (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.
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.
These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.
The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.
Detailed description
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. More than a third of patients with HER2-positive breast cancer develop brain metastases during the course of the disease. For patients with isolated brain progression, local treatment is recommended whenever possible (stereotaxic radiosurgery and / or surgery) as well as the continuation of systemic treatment previously initiated even if the evidence of a benefit is weak.
After local treatment these patients will have a higher risk of progression (cerebral and systemic). Therefore, the question of whether systemic treatment should be continued or changed remains an open question.
In a pooled analysis of two phase 1b studies, patients who continued systemic treatment with tucatinib (in combination with T-DM1 or with trastuzumab and capecitabine) after treatment directed to the central nervous system demonstrated a better prognosis than that of patients who stopped tucatinib.
The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with HER2-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.
These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.
We anticipate that adding tucatinib to the trastuzumab / pertuzumab regimen will control brain metastases, prolong progression-free survival, and improve patient quality of life.
The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients treated with pertuzumab and trastuzumab for metastatic breast cancer who will develop an isolated brain relapse treated with local treatment will receive tucatinib in addition to pertuzumab and trastuzumab. Tucatinib will be taken orally 300 mg twice a day, pertuzumab (420 mg) and trastuzumab (6 mg/kg) will be taken every 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Tucatinib plus systemic treatment with or without hormone therapy | Experimental | Drug: Tucatinib, Drug: Pertuzumab, Drug: Trastuzumab, Drug: Hormone therapy, Drug: Pertuzumab/ TrastuzumabAddition of tucatinib to the systemic treatment (pertuzumab and trastuzumab) with or without hormone therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female, Age ≥18;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1;
- Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology;
- Documented isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) under pertuzumab and trastuzumab treatment (with or without taxane) for metastatic disease (There is no limit to the number and size of brain metastasis);
- Complete local treatment of brain progression (Surgery and/or radiation therapy) should have been completed no more than 12 weeks before inclusion and there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator;
Key exclusion criteria (15 listed)
- Radiologic extra-cranial progression under pertuzumab and trastuzumab treatment, at the time of enrolment. The systemic disease must be stable or responding at the time of enrolment;
- Proven leptomeningeal disease;
- Any progressive brain lesion between the brain local treatment completion and the enrolment;
- Poorly controlled seizures (more than 1/week);
- Clinically significant cardiopulmonary disease;
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 |
|---|---|---|
| Tucatinib300 mg orally twice daily | Drug | Tucatinib plus systemic treatment with or without hormone therapy |
| PertuzumabAlso: Perjeta®Initial loading: 840 mg Maintenance: 420 mg, 3-weekly | Drug | Tucatinib plus systemic treatment with or without hormone therapy |
| TrastuzumabAlso: Herceptin® or BiosimilarIntravenous formulation : Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly Subcutaneous formulation: 600 mg (fixed dose regardless of patient's body weight), 3-weekly | Drug | Tucatinib plus systemic treatment with or without hormone therapy |
| Hormone therapyAnastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection) | Drug | Tucatinib plus systemic treatment with or without hormone therapy |
| Pertuzumab/ TrastuzumabAlso: Phesgo®Initial loading: 1200 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight) Maintenance: 600 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight), 3-weekly | Drug | Tucatinib plus systemic treatment with or without hormone therapy |
Primary outcome
Progression-Free Survival
Time frame: 6 months
The progression-free survival is defined as the proportion of patients with an objective tumor progression by imaging, or death from any cause, whichever occurs first at 6 months from inclusion. Progression will be determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in case of lesions identified at baseline. For patients without any evidence of evidence at inclusion, the progression will be defined as an appearance of a new lesion (measurable or not measurable).
4 secondary outcomes
Overall Survival
Time frame: Throughout study completion, up to 18 months
Brain Progression-Free Survival
Time frame: Throughout study completion, up to 18 months
Overall brain metastasis response
Time frame: Throughout study completion, up to 18 months
Incidence of treatment-emergent Adverse Events
Time frame: Throughout study completion, up to 18 months
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 17 Nov 2025.
- 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.
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. This study is not recruiting at the moment.
Thomas Bachelot, MD principal investigator
Centre Leon Berard
Anne-Claire Hardy-Bessard, MD principal investigator
Centre Armoricain d'Oncologie
16 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 Tucatinib, Pertuzumab and Trastuzumab in people with Metastatic Breast Cancer With a Isolated Brain Progression, run by UNICANCER at 16 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 21 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 6 months). 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 17 Nov 2025.