HER2-positive Breast CancerPhase 2NCT06016387
Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
A Phase 2 study testing Tucatinib 150 MG, Trastuzumab and Capecitabine in people with HER2-positive Breast Cancer and LMD, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial summary
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer, LMD
- What is being tested?
- Tucatinib 150 MG, Trastuzumab and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Nov 2023to 5 Oct 2028
- 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
- Men or women with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer. HER2+ status will be defined in accordance with ASCO-CAP 2018 guidelines, and can be diagnosed at any time prior to enrolment. HER2 mutations and/or HER2-amplifications can be identified in the blood and/or cerebrospinal fluid (CSF) at any time prior to enrolment; testing blood and/or CSF is not part of the study protocol and must be evaluated using a clinically validated test.
- Evidence of LMD* in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD). Measurable disease in the central nervous system is not required. * The diagnosis of LMD can occur at any time prior to enrolment;
- Age 18+ at time of consent;
- ECOG ≤ 2;
- More than 14 days or 5 half-lives from the last dose of any experimental agent is required, whichever is greater;
- All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1 prior to enrollment, except for alopecia; neuropathy, must have resolved to ≤ Grade 2.
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- Phase 2: Inclusion Criteria
- Left ventricular ejection fraction (LVEF) must be within institutional limits of normal as assessed by ECHO or MUGA documented within 2 weeks prior to starting systemic therapy on the study;
- Adequate hematologic, liver, and renal function within 2 weeks prior to phase 2 enrollment, as follows:
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1 x109/L
- Platelets ≥ 100 x109/L
- Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
- AST and ALT ≤ 2.5X ULN
- International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN
- Creatinine clearance (CrCL) ≥ 50 mL/min
- The last dose of prior therapy must have been completed 14 days prior to study enrollment. Prior chemotherapy, immunotherapy, endocrine therapy, targeted therapy and experimental agents are allowed (including prior use of trastuzumab or other antibody-based therapy). Prior use of capecitabine either alone or in combination with other HER2-targeted therapies (including other tyrosine kinase inhibitors) is permitted;
Who cannot join
- Prior WBRT for brain metastases (prior stereotactic radiosurgery for parenchymal CNS metastases received <7 days prior to consent );
- Prior therapy specifically directed at LMD, including prior radiotherapy or systemic therapy;
- Inability to comply with MRI-based surveillance of CNS disease;
- Inability to swallow pills or any significant gastrointestinal diseases such as inflammatory bowel disease who suffer from uncontrolled diarrhea (based on the investigator's assessment),, which would preclude adequate absorption of oral medications;
- Diagnosed with Hereditary fructose intolerance;
- Diagnosed with Gilbert's disease;
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- Prior history of other cancer (except non melanoma skin, cervical intraepithelial neoplasia) with evidence of disease within the last 5 years;
- Prior use of tucatinib at any time prior to enrollment.
- Hypersensitivity to any of the active substances in tucatinib, trastuzumab, or capecitabine.
- Phase 2:
- Currently pregnant or breastfeeding;
- Use 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 the first dose of systemic therapy (see Appendix C and D);
- Myocardial infarction or unstable angina within 6 months prior to the first dose of systemic therapy.
- Blood product transfusions in order to meet eligibility criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
climb-lmd@sunnybrook.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Katarzyna Jerzak, MD, katarzyna.jerzak@sunnybrook.ca
Naema Yousuf, naema.yousuf@sunnybrook.ca
About this study
The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
Read the detailed description
Breast cancer is the most common cancer among women worldwide, and the second leading cause of brain metastases (BrM). Despite recent treatment advances, the prognosis of patients with breast cancer BrM remains poor, and the prognosis among those with leptomeningeal disease (LMD) is particularly dire with a median survival of only 2-4 months.
Patients with HER2+ metastatic breast cancer have a high life-time risk of central nervous system (CNS) metastases, with an approximately 50% lifetime risk. Although the cause of death among patients with breast cancer BrM is challenging to ascertain, approximately 50% of patients with HER2+ BrM are thought to die from central nervous system (CNS) disease involvement. Among patients with LMD specifically, the cause of death is most commonly related to CNS disease.
In an analysis of 430 patients (96 of whom had breast cancer) treated for LMD in the National Cancer Database between 2005 and 2014, those patients treated with chemotherapy plus radiotherapy had a longer median overall survival of 5 months (3.5 - 6.5 months) compared to patients treated with XRT or chemotherapy alone. In addition, a majority (n=18/26, 69%) of observational studies irrespective of primary tumor site have shown an "improvement or likely improvement" in survival with the use of XRT for LMD, either alone or in combination with systemic therapy. Hence, this proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy (which is considered standard of care) among patients with HER2+ metastatic breast cancer and LMD.
In addition to enrolling patients with established HER2+ metastatic breast cancer, those with HER2 mutations and/or HER2-amplifications in their blood and/or CSF are also eligible to enroll. This is on the basis that the HER2 status is known to "flip" in a relatively high proportion of patients from HER2-negative to HER2-positive at the time that CNS metastases develop51, 52, 53. Given that HER2 status of CNS metastases is not easy to obtain (most patients with CNS metastases do not have surgical resection or biopsy to obtain tissue due to the invasive nature of this surgical approach), patients with fluid samples suggestive of a HER2-driven malignancy (HER2 mutations and/or amplifications) in the blood and/or CSF will be permitted to enrol. Most patients with HER2 amplified tumors would be considered to have HER2-positive disease on tissue samples, but ASCO/CAP guidelines for HER2-positive status only apply to tissue; hence, a separate inclusion criterion for these patients has been established.
- Conditions
- HER2-positive Breast Cancer, LMD
- Being tested
- Tucatinib 150 MG, Trastuzumab, Capecitabine, Brain & Spinal Radiation
- Keywords
- HER2+, Breast Cancer, Leptomeningeal disease, Tucanitib, CLIMB-LMD, HER2 CLIMB LMD, CLIMB LMD HER2+
- Medical subject headings
- Breast Neoplasms, Meningeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tucatinib 150 MGDrug
Also called Tukysa
Tucatinib is a potent, selective, adenosine triphosphate-competitive small-molecule inhibitor of the receptor tyrosine kinase HER2. The molecular formula for tubatinib is C26H24N8O2 and it has a molecular weight of 480.52 g/mol.
TrastuzumabDrug
MYL-1401O contains the active substance trastuzumab, which is an IgG1 monoclonal antibody. The molecular size of the intact molecule is around 148 kDa.
Each vial of MYL-1401O contains 150 mg of lyophilized proposed active biosimilar substance trastuzumab as well as 3.36 mg L-Histidine Hydrochloride, 2.16 mg L-Histidine, 115.2 mg sorbitol and 33.6 mg PEG-3350 (Macrogol 3350). Sorbitol and PEG-3350 substitute the α- trehalose dehydrate and polysorbate-20, which are used as excipients in the EU-approved and US-licensed Herceptin formulations.
CapecitabineDrug
Capecitabine is a tumour-activated antineoplastic agent (antimetabolite). The molecular formula for capecitabine is C15H22FN3O6 and has a molecular weight of 359.35 g/mol.
Brain & Spinal RadiationRadiation
Also called Brain & Spinal XRT
Brain \& Spinal XRT is a treatment for patients with HER2+ metastatic breast cancer and leptomeningeal disease,
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib, Transtuzumab, Capecitabine | Experimental | Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease. Receives: Drug: Tucatinib 150 MG; Drug: Trastuzumab; Drug: Capecitabine; Radiation: Brain & Spinal Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival status from the start of XRT
To assess overall survival (OS) in the intention to treat population from the start of XRT.
Measured: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (7)
Time to CNS progression from the start of XRT
To determine the time for CNS symptoms progresses from start of XRT in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Safety and tolerability (CTCAE v.5.0)
To determine the safety \& tolerability of systemic therapy (tucatinib, trastuzumab and capecitabine) in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Progression free survival from the start of XRT
To determine progression from the start of XRT in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
CNS specific objective response (RANO-BM)
To determine the CNS objective response in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: Every 6 weeks through study completion, an average of 5 years
Extracranial objective response (RECIST v1.1)
To determine the extracranial objective response in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: Every 6 weeks through study completion, an average of 5 years
Neurologic-specific QoL (FACT-BR version 4)
To determine the neurologic-specific QoL's in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
Overall QoL (EORTC QLQ-C30 version 3)
To determine the Overall QoL in the proposed patient population after completion of brain and/or spinal XRT.
To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
Measured: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start25 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion5 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Biocon Biologics, Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016387
- Sponsor's protocol ID
- CLIMB-LMD
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study
- ClinicalTrials.gov ID
- NCT06016387
- Acronym / sponsor ID
- CLIMB-LMD
- Conditions
- HER2-positive Breast Cancer, LMD
- Keywords
- HER2+, Breast Cancer, Leptomeningeal disease, Tucanitib, CLIMB-LMD, HER2 CLIMB LMD, CLIMB LMD HER2+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Biocon Biologics, Pfizer
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 29 Aug 2023 (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 proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy among patients with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer and LMD
Detailed description
Breast cancer is the most common cancer among women worldwide, and the second leading cause of brain metastases (BrM). Despite recent treatment advances, the prognosis of patients with breast cancer BrM remains poor, and the prognosis among those with leptomeningeal disease (LMD) is particularly dire with a median survival of only 2-4 months.
Patients with HER2+ metastatic breast cancer have a high life-time risk of central nervous system (CNS) metastases, with an approximately 50% lifetime risk. Although the cause of death among patients with breast cancer BrM is challenging to ascertain, approximately 50% of patients with HER2+ BrM are thought to die from central nervous system (CNS) disease involvement. Among patients with LMD specifically, the cause of death is most commonly related to CNS disease.
In an analysis of 430 patients (96 of whom had breast cancer) treated for LMD in the National Cancer Database between 2005 and 2014, those patients treated with chemotherapy plus radiotherapy had a longer median overall survival of 5 months (3.5 - 6.5 months) compared to patients treated with XRT or chemotherapy alone. In addition, a majority (n=18/26, 69%) of observational studies irrespective of primary tumor site have shown an "improvement or likely improvement" in survival with the use of XRT for LMD, either alone or in combination with systemic therapy. Hence, this proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy (which is considered standard of care) among patients with HER2+ metastatic breast cancer and LMD.
In addition to enrolling patients with established HER2+ metastatic breast cancer, those with HER2 mutations and/or HER2-amplifications in their blood and/or CSF are also eligible to enroll. This is on the basis that the HER2 status is known to "flip" in a relatively high proportion of patients from HER2-negative to HER2-positive at the time that CNS metastases develop51, 52, 53. Given that HER2 status of CNS metastases is not easy to obtain (most patients with CNS metastases do not have surgical resection or biopsy to obtain tissue due to the invasive nature of this surgical approach), patients with fluid samples suggestive of a HER2-driven malignancy (HER2 mutations and/or amplifications) in the blood and/or CSF will be permitted to enrol. Most patients with HER2 amplified tumors would be considered to have HER2-positive disease on tissue samples, but ASCO/CAP guidelines for HER2-positive status only apply to tissue; hence, a separate inclusion criterion for these patients has been established.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucatinib, Transtuzumab, Capecitabine | Experimental | Drug: Tucatinib 150 MG, Drug: Trastuzumab, Drug: Capecitabine, Radiation: Brain & Spinal RadiationTucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men or women with HER2+, HER2 mutated and/or HER2-amplified metastatic breast cancer. HER2+ status will be defined in accordance with ASCO-CAP 2018 guidelines, and can be diagnosed at any time prior to enrolment. HER2 mutations and/or HER2-amplifications can be identified in the blood and/or cerebrospinal fluid (CSF) at any time prior to enrolment; testing blood and/or CSF is not part of the study protocol and must be evaluated using a clinically validated test.
- Evidence of LMD* in the brain and/or spine (either positive cerebral spinal fluid cytology and/or magnetic resonance imaging evidence of LMD). Measurable disease in the central nervous system is not required. * The diagnosis of LMD can occur at any time prior to enrolment;
- Age 18+ at time of consent;
- ECOG ≤ 2;
- More than 14 days or 5 half-lives from the last dose of any experimental agent is required, whichever is greater;
Key exclusion criteria (14 listed)
- Prior WBRT for brain metastases (prior stereotactic radiosurgery for parenchymal CNS metastases received <7 days prior to consent );
- Prior therapy specifically directed at LMD, including prior radiotherapy or systemic therapy;
- Inability to comply with MRI-based surveillance of CNS disease;
- Inability to swallow pills or any significant gastrointestinal diseases such as inflammatory bowel disease who suffer from uncontrolled diarrhea (based on the investigator's assessment),, which would preclude adequate absorption of oral medications;
- Diagnosed with Hereditary fructose intolerance;
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 |
|---|---|---|
| Tucatinib 150 MGAlso: TukysaTucatinib is a potent, selective, adenosine triphosphate-competitive small-molecule inhibitor of the receptor tyrosine kinase HER2. The molecular formula for tubatinib is C26H24N8O2 and it has a molecular weight of 480.52 g/mol. | Drug | Tucatinib, Transtuzumab, Capecitabine |
| TrastuzumabMYL-1401O contains the active substance trastuzumab, which is an IgG1 monoclonal antibody. The molecular size of the intact molecule is around 148 kDa. Each vial of MYL-1401O contains 150 mg of lyophilized proposed active biosimilar substance trastuzumab as well as 3.36 mg L-Histidine Hydrochloride, 2.16 mg L-Histidine, 115.2 mg sorbitol and 33.6 mg PEG-3350 (Macrogol 3350). Sorbitol and PEG-3350 substitute the α- trehalose dehydrate and polysorbate-20, which are used as excipients in the EU-approved and US-licensed Herceptin formulations. | Drug | Tucatinib, Transtuzumab, Capecitabine |
| CapecitabineCapecitabine is a tumour-activated antineoplastic agent (antimetabolite). The molecular formula for capecitabine is C15H22FN3O6 and has a molecular weight of 359.35 g/mol. | Drug | Tucatinib, Transtuzumab, Capecitabine |
| Brain & Spinal RadiationAlso: Brain & Spinal XRTBrain \& Spinal XRT is a treatment for patients with HER2+ metastatic breast cancer and leptomeningeal disease, | Radiation | Tucatinib, Transtuzumab, Capecitabine |
Primary outcome
Survival status from the start of XRT
Time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
To assess overall survival (OS) in the intention to treat population from the start of XRT.
7 secondary outcomes
Time to CNS progression from the start of XRT
Time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Safety and tolerability (CTCAE v.5.0)
Time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Progression free survival from the start of XRT
Time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
CNS specific objective response (RANO-BM)
Time frame: Every 6 weeks through study completion, an average of 5 years
Extracranial objective response (RECIST v1.1)
Time frame: Every 6 weeks through study completion, an average of 5 years
Neurologic-specific QoL (FACT-BR version 4)
Time frame: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
Overall QoL (EORTC QLQ-C30 version 3)
Time frame: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
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 Feb 2026.
- Individual participant dataSharing planned: No. The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
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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.
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 Tucatinib 150 MG, Trastuzumab and Capecitabine in people with HER2-positive Breast Cancer and LMD, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
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 17 inclusion and 14 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 Feb 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 Canada. 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 CLIMB-LMD Project Manager (437-247-2617, CLIMB-LMD@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival status from the start of XRT (time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 23 Feb 2026.