Geriatric AssessmentFUTURENCT07273357
Aspects of Adjuvant CDK4/6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening
An observational study of Geriatric Assessment and Adjuvant Drug Therapy, run by Region Jönköping County at 5 sites in Sweden.
Trial summary
Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4/6 inhibitors (CDK4/6i) administered in combination with endocrine therapy. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Geriatric Assessment, Adjuvant Drug Therapy, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- How many people
- 200 participants
- Where
- 5 sitesSweden
- Study dates
- 1 Apr 2026to 1 Aug 2039
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients with primary breast cancer, regardless of breast cancer subtype, who are ≥70 years old and starting adjuvant CDK4/6i are included in this trial.
Who may be able to join
- ≥70 years old
- Female/male
- Completed surgery (primary or after neoadjuvant therapy)
- Starting adjuvant CDK4/6i and endocrine therapy
- Cognitive performance to be able answer questionaries
- No language difficulties
Who cannot join
- Impaired cognitive function not able to understand the study intention or perform questionaries
- Declining adjuvant CDK4/6i
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Department of Oncology
Gävle
Ilke Cikman, MD, ilke.cikman@regiongavleborg.se
- Recruiting
Department of Oncology
Jönköping, 55312
Christine Lundgren, MD, +46102422907, christine.lundgren@rjl.se
- Recruiting
Department of Oncology
Kalmar
Petra Hinnen, MD, petra.hinnen@regionkalmar.se
- Recruiting
Department of Oncology
Linköping
Jimmy Ekstrand, MD, jimmy.ekstrand@regionostergotland.se
- Not yet recruiting
Department of Oncology
Örebro
Antonios Valachis, MD, antonios.valachis@oru.se
About this study
Official title: Follow-Up After adjuvanT CDK4/6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)
Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4/6 inhibitors (CDK4/6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4/6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4/6i therapy.
This study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4/6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4/6i therapy in this specific patient population.
Read the detailed description
Adjuvant systemic therapy for breast cancer incorporates many different treatment modalities. CDK4/6 inhibitors (CDK4/6i) were initially approved in the metastatic setting, but now also as adjuvant treatment, concomitant with endocrine therapy for patients with estrogen-receptor positive/human epidermal growth factor receptor 2 -negative (ER+/HER2-) disease.
Only 15% of the study population in MonarchE was aged 65 and older, and the median age of 51 years is a decade younger than in the advanced setting pivotal studies. The median age in NATALEE was similarly 52 years, including only 773 out of 5,101 aged ≥65 years. Subgroup analysis from the MonarchE trial suggests benefit also in those >65 years old, but no statistically significant results exist so far. This might be attributed to a relatively small number of older participants, and the fact that these subgroup analyses were not pre-planned.
At present, specific guidelines regarding the use of adjuvant CDK4/6i in older patients are lacking. Given the importance of tailoring adjuvant treatment in this population, the implementation of geriatric screening in patients ≥70 years who are candidates for adjuvant CDK4/6i therapy is warranted. Furthermore, it is of clinical relevance to investigate the associations between geriatric screening assessment, quality of life, treatment-related toxicity, and discontinuation in this cohort. Outcomes such as hospitalization rates, recurrence, survival, and treatment dose intensity are also of particular interest in this patient population.
The hypothesis that the use of geriatric screening in routine clinical practice will reveal a relationship between frailty and decreased quality of life and higher risk of developing CDK4/6i toxicity. The investigators moreover anticipate a correlation between higher frailty and lower dose intensity, and poorer outcomes in terms of recurrence and survival.
The overall aim of this study is to examine different aspects of adjuvant CDK4/i in older early breast cancer patients. In more detail the aims are to investigate the association between geriatric frailty assessment (based on screening by the Geriatric 8 (G8) and Vulnerable Elders Survey-13 (VES-13) screening tools in older breast cancer patients that are to be treated with adjuvant CDK4/6i, and the risk of treatment side effects, discontinuation, patients reported quality of life, and hospitalization. Moreover, the investigators aim at exploring the correlation between frailty as assessed by geriatric screening and dose intensity and this impact on recurrence/survival. As exploratory analysis, different cut-offs for G8 and VES-13 score will be investigated in order to find stronger correlation between vulnerability/frailty and long-term outcomes in this patient cohort, and finally a comparison between the G8 and VES-13 performance.
In detail, the primary objectives are:
- Association between frailty as assessed by G8 and VES-13 screening and CDK4/6i treatment side effects (adverse event (AE) grade ≥3)
- Association between frailty as assessed by G8 and VES-13 screening and quality of life after initiating CDK4/6i, as reported by the patient
- Association between frailty as assessed by G8 and VES-13 screening and hospitalization due to CDK4/6i The secondary objectivs are:
- Association between frailty as assessed by G8 and VES-13 screening and relative dose intensity (RDI, defined as the ratio of the drug dose administered in the actual time, over the planned dose in the planned time) by CDK4/6i and impact on breast cancer recurrence, overall and breast cancer-specific survival after 3, 5 and 10 years, respectively.
As exploratory analysis the following will be performed:
- Explore whether different cut-offs of G8 and VES-13 score would result in a stronger correlation between vulnerability/frailty and long-term outcomes in this patient cohort. 2. Compare which geriatric screening tool that is more associated to outcomes
- Conditions
- Geriatric Assessment, Adjuvant Drug Therapy, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Keywords
- Older patients, Geriatric screening, Adjuvant CDK4/6 inhibitors, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail and fit older (≥70 years) breast cancer patients | Older (≥70 years) patients, with early stage breast cancer, initiating adjuvant CDK4/6 inhibitors that are defined as frail or fit according to G8 and VES-13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty as assessed by Geriatric 8 (G8)
Geriatric 8 (G8) geriatric screening. 8 questions. Generating total score (0-17). ≤14 indicates frailty.
Measured: Baseline
Frailty as assessed by Vulnerable Elders Survey (VES-13)
Vulnerable Elders Survey (VES-13) geriatric screening, 13 questions. Generating total score (0-10). ≥3 indicates frailty.
Measured: Baseline
Secondary outcomes (10)
Global health status and Quality of Life (QoL) (GHS)
Global health status and Quality of Life (QoL) (GHS) comprises the two seven-point Likert scale from the EORTC QLQ-C30 regarding overall health and QoL during the past week.
Measured: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.
Summary score
Comprise all questions from the EORTC QLQ-C30 except for those included in the Global health status and Quality of Life (QoL) (GHS) and a question concerning financial difficulties. Scores range from 0 (no Health-related quality of life (HRQOL)) to 100 (the highest HRQoL).
Measured: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation
Ten scales
Ten scales include five function scales and five symptom scales from the EORTC-QLQ-C30 and ELD14. Scales included physical, role, and social functioning, fatigue, and pain from the EORTC-QLQ-C30 and maintaining purpose, family support, mobility, future worries, and burden of illness from the EORTC-QLQ ELD14. Scores from all scales range from 0 to 100. High scores for functional scales represent high and healthy functioning, whereas high scores for symptom scales represent high symptomatology.
Measured: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.
Adverse events
≥ Grad 3 adverse events (AE) from CDK4/6 inhibitor (CDK4/6i) according to the CTCAE 5.0
Measured: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Hospitalization
Hospitalization rate
Measured: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6inhibitor (CDK4/6i) initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Dose adjustment
Change in CDK4/6 inhibitor (CDK4/6i) dosage
Measured: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Treatment discontinuation
End of CDK4/6inhibitor (CDK4/6i) treatment
Measured: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Relative dose intensity (RDI)
RDI; defined as the ratio of the drug dose administered in the actual time, over the planned dose in the planned time
Measured: At 24 and 36 months for those treated with Abemaciclib and Ribociclib, respectively
Berast cancer recurrence
Recurrence (locoregional, distant, in situ)
Measured: At 3, 5, 10 years
Survival
Breast cancer specific and overall survival
Measured: At 3, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Apr 2026
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Aug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Jönköping County
- Sponsor type
- Other government
- Collaborators
- Region Örebro County, Region Östergötland, Region Gävleborg, Västra Götalandsregionen, Linkoeping University, Örebro University, Sweden, Kalmar County Hospital
- Responsible party
- Principal investigator, Christine Lundgren, Region Jönköping County
- Investigators
- Christine Lundgren, MD, Study chair, Department of Oncology, Jönköping, Region Jönköping County, Jönköping; Sweden,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273357
- Sponsor's protocol ID
- EPM 2025-06207-01
- Acronym
- FUTURE
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sjoberg J, Smith DR, Ekstrand J, Hinnen P, Cikman I, Valachis A, Lundgren C. Follow-Up after adjuvanT CDK4/6i Use in oldeR brEst cancer patients - aspects on geriatric screening, toxicities, and quality of life (FUTURE): A prospective observational cohort study. J Geriatr Oncol. 2026 Oct 11;18(1):104639. doi: 10.1016/j.jgo.2026.104639. Online ahead of print.
PubMed 42860071
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up After adjuvanT CDK4/6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)
- ClinicalTrials.gov ID
- NCT07273357
- Acronym / sponsor ID
- FUTURE / EPM 2025-06207-01
- Conditions
- Geriatric Assessment, Adjuvant Drug Therapy, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Keywords
- Older patients, Geriatric screening, Adjuvant CDK4/6 inhibitors, Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region Jönköping CountyOther government
- Collaborators
- Region Örebro County, Region Östergötland, Region Gävleborg, Västra Götalandsregionen, Linkoeping University, Örebro University, Sweden, Kalmar County Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Aug 2039 (estimated)
- First posted
- 9 Dec 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.
Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4/6 inhibitors (CDK4/6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4/6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4/6i therapy.
This study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4/6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4/6i therapy in this specific patient population.
Detailed description
Adjuvant systemic therapy for breast cancer incorporates many different treatment modalities. CDK4/6 inhibitors (CDK4/6i) were initially approved in the metastatic setting, but now also as adjuvant treatment, concomitant with endocrine therapy for patients with estrogen-receptor positive/human epidermal growth factor receptor 2 -negative (ER+/HER2-) disease.
Only 15% of the study population in MonarchE was aged 65 and older, and the median age of 51 years is a decade younger than in the advanced setting pivotal studies. The median age in NATALEE was similarly 52 years, including only 773 out of 5,101 aged ≥65 years. Subgroup analysis from the MonarchE trial suggests benefit also in those >65 years old, but no statistically significant results exist so far. This might be attributed to a relatively small number of older participants, and the fact that these subgroup analyses were not pre-planned.
At present, specific guidelines regarding the use of adjuvant CDK4/6i in older patients are lacking. Given the importance of tailoring adjuvant treatment in this population, the implementation of geriatric screening in patients ≥70 years who are candidates for adjuvant CDK4/6i therapy is warranted. Furthermore, it is of clinical relevance to investigate the associations between geriatric screening assessment, quality of life, treatment-related toxicity, and discontinuation in this cohort. Outcomes such as hospitalization rates, recurrence, survival, and treatment dose intensity are also of particular interest in this patient population.
The hypothesis that the use of geriatric screening in routine clinical practice will reveal a relationship between frailty and decreased quality of life and higher risk of developing CDK4/6i toxicity. The investigators moreover anticipate a correlation between higher frailty and lower dose intensity, and poorer outcomes in terms of recurrence and survival.
The overall aim of this study is to examine different aspects of adjuvant CDK4/i in older early breast cancer patients. In more detail the aims are to investigate the association between geriatric frailty assessment (based on screening by the Geriatric 8 (G8) and Vulnerable Elders Survey-13 (VES-13) screening tools in older breast cancer patients that are to be treated with adjuvant CDK4/6i, and the risk of treatment side effects, discontinuation, patients reported quality of life, and hospitalization. Moreover, the investigators aim at exploring the correlation between frailty as assessed by geriatric screening and dose intensity and this impact on recurrence/survival. As exploratory analysis, different cut-offs for G8 and VES-13 score will be investigated in order to find stronger correlation between vulnerability/frailty and long-term outcomes in this patient cohort, and finally a comparison between the G8 and VES-13 performance.
In detail, the primary objectives are:
- Association between frailty as assessed by G8 and VES-13 screening and CDK4/6i treatment side effects (adverse event (AE) grade ≥3)
- Association between frailty as assessed by G8 and VES-13 screening and quality of life after initiating CDK4/6i, as reported by the patient
- Association between frailty as assessed by G8 and VES-13 screening and hospitalization due to CDK4/6i The secondary objectivs are:
- Association between frailty as assessed by G8 and VES-13 screening and relative dose intensity (RDI, defined as the ratio of the drug dose administered in the actual time, over the planned dose in the planned time) by CDK4/6i and impact on breast cancer recurrence, overall and breast cancer-specific survival after 3, 5 and 10 years, respectively.
As exploratory analysis the following will be performed:
- Explore whether different cut-offs of G8 and VES-13 score would result in a stronger correlation between vulnerability/frailty and long-term outcomes in this patient cohort. 2. Compare which geriatric screening tool that is more associated to outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail and fit older (≥70 years) breast cancer patients | – | –Older (≥70 years) patients, with early stage breast cancer, initiating adjuvant CDK4/6 inhibitors that are defined as frail or fit according to G8 and VES-13 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients with primary breast cancer, regardless of breast cancer subtype, who are ≥70 years old and starting adjuvant CDK4/6i are included in this trial.
Key inclusion criteria (6 listed)
- ≥70 years old
- Female/male
- Completed surgery (primary or after neoadjuvant therapy)
- Starting adjuvant CDK4/6i and endocrine therapy
- Cognitive performance to be able answer questionaries
Key exclusion criteria (2 listed)
- Impaired cognitive function not able to understand the study intention or perform questionaries
- Declining adjuvant CDK4/6i
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty as assessed by Geriatric 8 (G8)
Time frame: Baseline
Geriatric 8 (G8) geriatric screening. 8 questions. Generating total score (0-17). ≤14 indicates frailty.
Frailty as assessed by Vulnerable Elders Survey (VES-13)
Time frame: Baseline
Vulnerable Elders Survey (VES-13) geriatric screening, 13 questions. Generating total score (0-10). ≥3 indicates frailty.
10 secondary outcomes
Global health status and Quality of Life (QoL) (GHS)
Time frame: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.
Summary score
Time frame: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation
Ten scales
Time frame: Baseline, 6,12, 24, 36, 60 months from CDK4/6inhibitor initiation.
Adverse events
Time frame: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Hospitalization
Time frame: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6inhibitor (CDK4/6i) initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Dose adjustment
Time frame: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Treatment discontinuation
Time frame: At 6, 12, 18, 24, 30, 36, 42 months after CDK4/6i initation. Last timepoint is 6 months after ending CDK/6i (e.g 30 months for those treated Abemaciclib and 42 months for those treated with Ribociclib, respectively).
Relative dose intensity (RDI)
Time frame: At 24 and 36 months for those treated with Abemaciclib and Ribociclib, respectively
Berast cancer recurrence
Time frame: At 3, 5, 10 years
Survival
Time frame: At 3, 5, 10 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 10 Jun 2026.
- Derived from this study: PubMed 42860071Sjoberg J, Smith DR, Ekstrand J, Hinnen P, Cikman I, Valachis A, Lundgren C. Follow-Up after adjuvanT CDK4/6i Use in oldeR brEst cancer patients - aspects on geriatric screening, toxicities, and quality of life (FUTURE): A prospective observational cohort study. J Geriatr Oncol. 2026 Oct 11;18(1):104639. doi: 10.1016/j.jgo.2026.104639. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Christine Lundgren, MD study chair
Department of Oncology, Jönköping, Region Jönköping County, Jönköping; Sweden,
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Assessment and Adjuvant Drug Therapy, run by Region Jönköping County at 5 sites in Sweden.
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 6 inclusion and 2 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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.
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 Christine Lundgren, MD (+46102422907, christine.lundgren@rjl.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty as assessed by Geriatric 8 (G8) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273357, which also lists 1 linked publication.
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 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.