Metastatic Breast CancerPhase 3IMPORTANTNCT06044623
Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients
A Phase 3 study testing CDK 4/6 inhibitors and Endocrine therapy in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Region Örebro County at 12 sites in 6 countries.
Trial summary
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life
- What is being tested?
- CDK 4/6 inhibitors and Endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 1 Apr 2024to 31 May 2029
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The following inclusion criteria will be applied:
- Patients male or female aged at least 70 years old at the time of informed consent.
- Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.
- Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
- No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4/6-inhibitor initiation is allowed.
- Adjuvant treatment with CDK 4/6-inhibitors is allowed provided a disease-free interval from treatment end >12 months.
Show all 11Show fewer
- Either measurable disease or non-measurable bone only disease, but evaluable according to RECIST criteria 1.1.
- Written informed consent prior to any study-specific procedures.
- Adequate organ function as defined in the summary of product characteristics (SmPC) for the CDK 4/6-inhibitors that is planned to be used.
- Able to swallow capsules.
- Able to understand and consent in English language or in native language for each participating country.
Who cannot join
- Eligible patients will be excluded if they have one of the following criteria:
- Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
- Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
- Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.
- History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
- Participating in other interventional trial.
Trial locations and contacts
12 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 6 countries
Greece5 sites, 5 recruiting
- Not yet recruiting
Fourth Oncology Department & Comprehensive Clinical Trials Center, Metropolitan Hospital
Athens
Helena Linardou, Dr, elinardou@otenet.gr
- Not yet recruiting
Second Department of Medical Oncology, Hygeia Hospital
Athens
Paris Kosmidis, Dr, parkosmi@otenet.gr
- Not yet recruiting
Division of Oncology, Department of Medicine, University Hospital, University of Patras Medical School
Pátrai
Angelos Koutras, Prof, angkoutr@otenet.gr
- Not yet recruiting
Medical Oncology Unit, S. Andrew Hospital
Pátrai
Athina Christopoulou, Dr, athinachristo@hotmail.com
- Not yet recruiting
Second Department of Medical Oncology, Euromedica General Clinic
Thessaloniki
Elena Fountzila, Assoc Prof, elenafou@gmail.com
Italy2 sites, 2 recruiting
- Not yet recruiting
Radiation Oncology Unit - Oncology Department, Azienda Ospedaliero Universitaria Careggi
Florence
Icro Meattini, Assoc Prof, icro.meattini@unifi.it
Luca Visani, Dr, l.visani88@gmail.com
- Not yet recruiting
"Sandro Pitigliani" Department of Medical Oncology, Hospital of Prato
Prato
Laura Biganzoli, Prof, laura.biganzoli@uslcentro.toscana.it
Emanuela Risi, Dr, emanuela.risi@uslcentro.toscana.it
Sweden2 sites, 2 recruiting
- Recruiting
Department of Oncology, Örebro University Hospital
Örebro
Antonios Valachis, Assoc Prof, antonios.valachis@oru.se
- Not yet recruiting
Department of Oncology, Uppsala University Hospital
Uppsala, 75185
Hendrik Lindman, Assoc Prof, Henrik.lindman@igp.uu.se
Aglaia Schiza, Dr, Aglaia.schiza@igp.uu.se
Finland1 site, 1 recruiting
- Recruiting
Department of Oncology, Helsinki University Hospital Comprehensive Cancer Center and University of Helsinki
Helsinki
Peeter Karihtala, Prof, peeter.karihtala@hus.fi
Norway1 site, 1 recruiting
- Not yet recruiting
Department of Oncology, Akershus University Hospital (AHUS)
Oslo
Jürgen Geisler, Prof, jurgen.geisler@medisin.uio.no
Kamilla Fjermeros, Dr, Kamilla.Fjermeros@ahus.no
Spain1 site, 1 recruiting
- Not yet recruiting
Department of Medical Oncology, Hospital Clinic of Barcelona
Barcelona
Raquel Gomez, Dr, ragomez@recerca.clinic.cat
Montserrat Munoz, Dr, mmunoz@clinic.cat
About this study
Official title: Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.
On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.
This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life, Toxicity, Older Patients
- Being tested
- CDK 4/6 inhibitors, Endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK 4/6 inhibitorsDrug
Either Palbociclib, Ribociclib or Abemaciclib
Endocrine therapyDrug
Either Letrozole, Anastrozole, Exemestane or Fulvestrant in combination with CDK 4/6-inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) | Experimental | -1 level dose reduction as initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 100 mg x 1 for 21 days with 7 days off; or Ribociclib 400 mg x 1 for 21 days with 7 days off; or Abemaciclib 100 mg x 2 daily added to endocrine therapy. Receives: Drug: CDK 4/6 inhibitors; Drug: Endocrine therapy |
| Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) | Active comparator | Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy. Receives: Drug: CDK 4/6 inhibitors; Drug: Endocrine therapy |
| Full initial dose of CDK 4/6-inhibitor (fit patient cohort) | Other | Full initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy. Receives: Drug: CDK 4/6 inhibitors; Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
The time from randomization to treatment discontinuation because of any reason including disease progression, treatment toxicity, or death due to any cause.
Measured: Up to 5 years from treatment initiation
Secondary outcomes (8)
Overall treatment utility (OTU)
A composite endpoint that will be assessed at the first efficacy evaluation. OTU incorporates objective and participant-reported outcome measures of anticancer efficacy, tolerability and acceptability of treatment providing a simple "good, intermediate or poor" categorization of outcome.
Measured: Three months after treatment initiation
Overall survival
The time from randomization to death from any cause.
Measured: Up to 5 years from treatment initiation
Progression free survival
The time from randomization to first documented evidence of disease progression or death from any cause.
Measured: Up to 5 years from treatment initiation
Time to chemotherapy initiation
The time from randomization until the initiation of chemotherapy at any treatment line after CDK 4/6-inhibitors.
Measured: Up to 5 years from treatment initiation
Frequency of adverse events
Adverse events will be assessed based on adverse events, as graded by CTCAE v 5.0 before each cycle and up to 28 days after the end of CDK 4/6-inhibitors.
Measured: Up to 5 years from treatment initiation
Assessment of Quality of life
Quality of life will be assessed using three validated questionnaires, EORTC Quality of Life Questionnaire (QLQ)-C30, Elderly (ELD)-14, and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L).
Measured: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first
Time until Quality of life deterioration
QoL deterioration, defined as the time from randomization until any clinically meaningful worsening (using minimal important differences as cut-off) of any QoL aspect measured by the questionnaires.
Measured: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first
Cost effectiveness
Resource use, length of life and quality of life data will be collected during the trial for the purpose of conducting an economic evaluation.
Measured: Up to 24 months from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Apr 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 May 2029 (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 Metastatic Breast CancerStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- University of Patras, University of Florence, Azienda USL Toscana Centro, Helsinki University Central Hospital, Institute for Medical Technology Assessment - the Netherlands, Security Labs Consulting Limited, Circular Economy Foundation, Universidad Nacional de Educación a Distancia, Hellenic Cooperative Oncology Group, University Hospital, Akershus, Uppsala County Council, Sweden, Hospital Clinic of Barcelona, Phaze Clinical Research & Pharma Consulting, Bröstcancerförbundet, Eunomia Ltd, University of Applied Sciences and Arts Northwestern Switzerland, CareAcross, Örebro University, Sweden
- Responsible party
- Sponsor
- Investigators
- Antonios Valachis, Assoc Prof, Study chair, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044623
- Sponsor's protocol ID
- 280232
- Acronym
- IMPORTANT
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Valachis A, Biganzoli L, Christopoulou A, Fjermeros K, Fountzila E, Geisler J, Gomez-Bravo R, Karihtala P, Kosmidis P, Koutras A, Linardou H, Lindman H, Martinez-Ballestero I, Rodriguez AB, Meattini I, Munoz-Mateu M, Othman M, Psyrri A, Risi E, Schiza A, Spathas N, Utriainen M, Visani L, Ballesteros S, Basdekis I, Hay SD, Fotis T, Fricker S, de Graaf G, Jenset M, Kanters T, Lampropoulos K, Markou C, Mastoraki K, Nanou C, Reales Aviles JM, Santaholma M, Kosmidis T. Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients. Future Oncol. 2024;20(37):2937-2948. doi: 10.1080/14796694.2024.2413841. Epub 2024 Oct 21.
PubMed 39431459
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Geriatric Assessment for Dose Optimization of CDK 4/6-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial (IMPORTANT Trial)
- ClinicalTrials.gov ID
- NCT06044623
- Acronym / sponsor ID
- IMPORTANT / 280232
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Quality of Life, Toxicity, Older Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- University of Patras, University of Florence, Azienda USL Toscana Centro, Helsinki University Central Hospital, Institute for Medical Technology Assessment - the Netherlands, Security Labs Consulting Limited, Circular Economy Foundation, Universidad Nacional de Educación a Distancia, Hellenic Cooperative Oncology Group, University Hospital, Akershus, Uppsala County Council, Sweden, Hospital Clinic of Barcelona, Phaze Clinical Research & Pharma Consulting, Bröstcancerförbundet, Eunomia Ltd, University of Applied Sciences and Arts Northwestern Switzerland, CareAcross, Örebro University, Sweden
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 21 Sep 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.
IMPORTANT study is a multicenter, open-label, prospective, randomized-controlled, non-inferiority trial with a pragmatic approach involving older patients (≥ 70 years old) with advanced hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer, not amenable for curative treatment and without prior therapy for advanced disease, who are suitable to receive CDK 4/6-inhibitors plus endocrine therapy as first line therapy. The study implements two approaches with high level of evidence, namely the use of comprehensive geriatric assessment (CGA) approach in treatment decision making and the use of CDK 4/6-inhibitors as the initial treatment of choice, to investigate whether a common clinical practice (starting dose reduction of CDK 4/6-inhibitors in older patients) with evidence of low certainty can be standardized using a more individualized-based approach.
On the basis of baseline CGA assessment, patients will either receive full dose of CDK 4/6-inhibitors plus endocrine therapy (if patients are fit according to CGA) or be randomized to full dose vs. reduced initial dose of CDK 4/6-inhibitors (if vulnerable or frail according to CGA). The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy.
This project has received funding from the European Union's HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) | Experimental | Drug: CDK 4/6 inhibitors, Drug: Endocrine therapy-1 level dose reduction as initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 100 mg x 1 for 21 days with 7 days off; or Ribociclib 400 mg x 1 for 21 days with 7 days off; or Abemaciclib 100 mg x 2 daily added to endocrine therapy. |
| Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) | Active comparator | Drug: CDK 4/6 inhibitors, Drug: Endocrine therapyFull initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy. |
| Full initial dose of CDK 4/6-inhibitor (fit patient cohort) | Other | Drug: CDK 4/6 inhibitors, Drug: Endocrine therapyFull initial dose of either one of the CDK 4/6-inhibitors: Palbociclib 125 mg x 1 for 21 days with 7 days off; or Ribociclib 600 mg x 1 for 21 days with 7 days off; or Abemaciclib 150 mg x 2 daily) added to physician's choice endocrine therapy. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Patients male or female aged at least 70 years old at the time of informed consent.
- Histologically or cytologically confirmed diagnosis of HR-positive (defined as estrogen-receptor ≥ 1%), HER2-negative breast cancer according to analysis of the most recent tumor specimen by local laboratory.
- Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative treatment.
- No prior systemic treatment for advanced disease (recurrence during neo-/adjuvant endocrine therapy is allowed). A prior period of treatment with aromatase inhibitors or fulvestrant for up to 28 days from the CDK 4/6-inhibitor initiation is allowed.
- Adjuvant treatment with CDK 4/6-inhibitors is allowed provided a disease-free interval from treatment end >12 months.
Key exclusion criteria (6 listed)
- Patients considered from treating physician as non-suitable for treatment with CDK 4/6-inhibitors.
- Contraindications according to SmPC for the CDK 4/6-inhibitors that is planned to be used.
- Presence of visceral crisis, lymphangitis carcinomatosis, or leptomeningeal carcinomatosis.
- History of any other cancer (except of non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
- Participating in other interventional trial.
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 |
|---|---|---|
| CDK 4/6 inhibitorsEither Palbociclib, Ribociclib or Abemaciclib | Drug | Full initial dose of CDK 4/6-inhibitor (fit patient cohort), Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort), Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) |
| Endocrine therapyEither Letrozole, Anastrozole, Exemestane or Fulvestrant in combination with CDK 4/6-inhibitor | Drug | Full initial dose of CDK 4/6-inhibitor (fit patient cohort), Full initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort), Lower initial dose of CDK 4/6-inhibitor (vulnerable/frail patient cohort) |
Primary outcome
Time to treatment failure
Time frame: Up to 5 years from treatment initiation
The time from randomization to treatment discontinuation because of any reason including disease progression, treatment toxicity, or death due to any cause.
8 secondary outcomes
Overall treatment utility (OTU)
Time frame: Three months after treatment initiation
Overall survival
Time frame: Up to 5 years from treatment initiation
Progression free survival
Time frame: Up to 5 years from treatment initiation
Time to chemotherapy initiation
Time frame: Up to 5 years from treatment initiation
Frequency of adverse events
Time frame: Up to 5 years from treatment initiation
Assessment of Quality of life
Time frame: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first
Time until Quality of life deterioration
Time frame: Until disease progression, participant / physician decision to stop, death, or up to 24 months from treatment initiation whichever occurs first
Cost effectiveness
Time frame: Up to 24 months from treatment initiation
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 19 Nov 2024.
- Derived from this study: PubMed 39431459Valachis A, Biganzoli L, Christopoulou A, Fjermeros K, Fountzila E, Geisler J, Gomez-Bravo R, Karihtala P, Kosmidis P, Koutras A, Linardou H, Lindman H, Martinez-Ballestero I, Rodriguez AB, Meattini I, Munoz-Mateu M, Othman M, Psyrri A, Risi E, Schiza A, Spathas N, Utriainen M, Visani L, Ballesteros S, Basdekis I, Hay SD, Fotis T, Fricker S, de Graaf G, Jenset M, Kanters T, Lampropoulos K, Markou C, Mastoraki K, Nanou C, Reales Aviles JM, Santaholma M, Kosmidis T. Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients. Future Oncol. 2024;20(37):2937-2948. doi: 10.1080/14796694.2024.2413841. Epub 2024 Oct 21.
- 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.
Antonios Valachis, Assoc Prof study chair
Region Örebro län
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CDK 4/6 inhibitors and Endocrine therapy in people with Metastatic Breast Cancer and Advanced Breast Cancer, run by Region Örebro County at 12 sites in 6 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 11 inclusion and 6 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Greece, Italy, Sweden, Finland, Norway and 1 more country. 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 Antonios Valachis, Assoc Prof (+46196021792, important@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (time frame: Up to 5 years from treatment initiation). 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 NCT06044623, 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 19 Nov 2024.