Breast CancerPhase 2EarLEE-1NCT03078751
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
A Phase 2 study testing Ribociclib and Adjuvant endocrine therapy in people with Breast Cancer, run by Novartis Pharmaceuticals at 33 sites in United States.
Trial summary
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib and Adjuvant endocrine therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 33 sitesUnited States
- Study dates
- 20 Jun 2017to 9 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed unilateral primary invasive adenocarcinoma of the breast
- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer
- Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
- Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue
- Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ≥ 4 cycles or ≥ 12 weeks which included taxanes prior to screening
- Patient has completed adjuvant radiotherapy (if indicated) prior to screening
Show all 11Show fewer
- Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
- ECOG Performance Status 0 or 1
- Adequate bone marrow and organ function
- Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits
- QTcF interval < 450 msec and mean resting heart rate 50-90 bpm
Who cannot join
- Prior treatment with CDK4/6 inhibitor
- Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
- Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
- Distant metastases of breast cancer beyond regional lymph nodes
- Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias
Show all 10Show fewer
- Uncontrolled hypertension with systolic blood pressure >160 mmHg
- Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the study
- Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Northside Hospital Central Research Dept.
Atlanta, Georgia, 30342
CBCC Global Research
Bakersfield, California, 93309
The Presbyterian Hospital
Charlotte, North Carolina, 28210
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology P A Texas Oncology - Houston
Dallas, Texas, 75251
Rocky Mountain Cancer Centers Regulatory
Denver, Colorado, 80218
Fairfax Northern Virginia Hem/Onc
Fairfax, Virginia, 22031
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Florida Cancer Specialists South Region
Fort Myers, Florida, 33916
The West Clinic
Germantown, Tennessee, 38138
Memorial Regional Hospital
Hollywood, Florida, 33021
Millennium Oncology
Houston, Texas, 77090
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Div.
Leawood, Kansas, 66209
Saint Barnabas Medical Center 2nd Floor East Wing
Livingston, New Jersey, 07039
University of California - Los Angeles
Los Angeles, California, 90024
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203
Pro Health Care Associates
New Hyde Park, New York, 11042
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
Ventura County Hematology and Oncology
Oxnard, California, 93030
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
TRIO - Torrance Health Association
Redondo Beach, California, 90277
Cancer Care Network of South Texas
San Antonio, Texas, 78258
Summit Cancer Care, PC
Savannah, Georgia, 31405
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
Florida Cancer Specialists - North Florida Cancer Specialist N
St. Petersburg, Florida, 33705
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405
Northwest Medical Specialties
Tacoma, Washington, 98405
Arizona Oncology Associates PC- HAL
Tucson, Arizona, 85704
Texas Oncology PA - Tyler
Tyler, Texas, 75702
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
Innovative Clinical Research Institute
Whittier, California, 90603
About this study
Official title: An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
Read the detailed description
The purpose of this study was to evaluate the preliminary safety and tolerability of ribociclib to standard adjuvant endocrine therapy (ET) in patients with hormone receptor (HR) positive, Human Epidermal Growth Factor Receptor2 (HER2) negative high risk early breast cancer (EBC).
Originally, this was a randomized, Phase III, double-blind, placebo-controlled, multi-center, international study to evaluate efficacy and safety of ribociclib with ET as an adjuvant treatment in patients with HR-positive, HER2-negative, high risk EBC.
Patients were randomized at a ratio of 1:1 to receive either ribociclib or placebo for approximately 24 months in combination with a standard adjuvant ET with ET continued for at least 60 months.
However, following a review of the ribociclib development program strategy, a decision was taken to explore a different approach by initiating a single Phase III study for simplicity of trial logistics and for the purpose of analyzing the overall population through a single clinical trial. Therefore, this study was closed to enrollment early and was amended to be an open label, multi-center Phase II study conducted in the US only. All randomized patients were unblinded; patients randomized to placebo were permanently discontinued from the study and patients randomized to ribociclib were offered the option to continue treatment with ribociclib + ET.
The study included a screening phase (28 days), a treatment phase composed of maximum of 26 cycles of ribociclib in combination with ET (approximately 24 months) or until disease recurrence, intolerable toxicity, withdrawal of consent, or discontinuation from the study treatment for any other reason, whichever was earlier, and a 30 days safety follow up from last dose of ribociclib. Ribociclib was given orally once a day on days 1 to 21 in each 28 days cycle.
Safety was assessed for each patient until 30 days after the last dose of ribociclib and included routine safety monitoring except in case of death, loss to follow up or withdrawal of consent.
- Conditions
- Breast Cancer
- Being tested
- Ribociclib, Adjuvant endocrine therapy, Placebo
- Keywords
- Hormone receptor-positive, Estrogen and/or progesterone receptor-positive, HER2-negative, High risk early breast cancer, Adjuvant, Ribociclib, LEE011, CDK4/6 inhibitor, Endocrine therapy, Phase II, Breast carcinoma, 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.
RibociclibDrug
Also called LEE011
Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).
Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth.
Adjuvant endocrine therapyDrug
Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days.
PlaceboDrug
Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).
Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib + adjuvant endocrine therapy (ET) | Experimental | Patients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy.
ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2) Receives: Drug: Ribociclib; Drug: Adjuvant endocrine therapy |
| Placebo + adjuvant endocrine therapy (ET) | Placebo comparator | Patients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen Receives: Drug: Adjuvant endocrine therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Serious Adverse Events
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Measured: Up to 26 months
Percentage of Participants With Adverse Events and Serious Adverse Events
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start20 Jun 2017
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078751
- Sponsor's protocol ID
- CLEE011G2301
- Other IDs
- 2014-001795-53, 2014
- Acronym
- EarLEE-1
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2017
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the triasl in line with applicable laws and regulations. This trial data will be available according to the process described on www.clinicalstudydatarequest.com.
Publications
Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, Sparano JA, Hunsberger S, Enos RA, Gelber RD, Zujewski JA. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007 May 20;25(15):2127-32. doi: 10.1200/JCO.2006.10.3523.
PubMed 17513820Hortobagyi GN, Connolly JL, D'Orsi CJ, et al (2017). Breast. From AJCC Cancer Staging Manual 8th ed. By Amin MB, Edge S, Greene FL, et al. Springer
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03078751
- Acronym / sponsor ID
- EarLEE-1 / CLEE011G2301
- Conditions
- Breast Cancer
- Keywords
- Hormone receptor-positive, Estrogen and/or progesterone receptor-positive, HER2-negative, High risk early breast cancer, Adjuvant, Ribociclib, LEE011, CDK4/6 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 15 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
Detailed description
The purpose of this study was to evaluate the preliminary safety and tolerability of ribociclib to standard adjuvant endocrine therapy (ET) in patients with hormone receptor (HR) positive, Human Epidermal Growth Factor Receptor2 (HER2) negative high risk early breast cancer (EBC).
Originally, this was a randomized, Phase III, double-blind, placebo-controlled, multi-center, international study to evaluate efficacy and safety of ribociclib with ET as an adjuvant treatment in patients with HR-positive, HER2-negative, high risk EBC.
Patients were randomized at a ratio of 1:1 to receive either ribociclib or placebo for approximately 24 months in combination with a standard adjuvant ET with ET continued for at least 60 months.
However, following a review of the ribociclib development program strategy, a decision was taken to explore a different approach by initiating a single Phase III study for simplicity of trial logistics and for the purpose of analyzing the overall population through a single clinical trial. Therefore, this study was closed to enrollment early and was amended to be an open label, multi-center Phase II study conducted in the US only. All randomized patients were unblinded; patients randomized to placebo were permanently discontinued from the study and patients randomized to ribociclib were offered the option to continue treatment with ribociclib + ET.
The study included a screening phase (28 days), a treatment phase composed of maximum of 26 cycles of ribociclib in combination with ET (approximately 24 months) or until disease recurrence, intolerable toxicity, withdrawal of consent, or discontinuation from the study treatment for any other reason, whichever was earlier, and a 30 days safety follow up from last dose of ribociclib. Ribociclib was given orally once a day on days 1 to 21 in each 28 days cycle.
Safety was assessed for each patient until 30 days after the last dose of ribociclib and included routine safety monitoring except in case of death, loss to follow up or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribociclib + adjuvant endocrine therapy (ET) | Experimental | Drug: Ribociclib, Drug: Adjuvant endocrine therapyPatients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2) |
| Placebo + adjuvant endocrine therapy (ET) | Placebo comparator | Drug: Adjuvant endocrine therapy, Drug: PlaceboPatients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed unilateral primary invasive adenocarcinoma of the breast
- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer
- Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
- Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue
- Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ≥ 4 cycles or ≥ 12 weeks which included taxanes prior to screening
Key exclusion criteria (10 listed)
- Prior treatment with CDK4/6 inhibitor
- Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
- Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
- Distant metastases of breast cancer beyond regional lymph nodes
- Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery
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 |
|---|---|---|
| RibociclibAlso: LEE011Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth. | Drug | Ribociclib + adjuvant endocrine therapy (ET) |
| Adjuvant endocrine therapyLetrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days. | Drug | Placebo + adjuvant endocrine therapy (ET), Ribociclib + adjuvant endocrine therapy (ET) |
| PlaceboPlacebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth. | Drug | Placebo + adjuvant endocrine therapy (ET) |
Primary outcome
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 26 months
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Percentage of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to 26 months
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17513820Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, Sparano JA, Hunsberger S, Enos RA, Gelber RD, Zujewski JA. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007 May 20;25(15):2127-32. doi: 10.1200/JCO.2006.10.3523.
- Results publicationHortobagyi GN, Connolly JL, D'Orsi CJ, et al (2017). Breast. From AJCC Cancer Staging Manual 8th ed. By Amin MB, Edge S, Greene FL, et al. Springer
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the triasl in line with applicable laws and regulations. This trial data will be available according to the process described on www.clinicalstudydatarequest.com.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
33 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 Ribociclib and Adjuvant endocrine therapy in people with Breast Cancer, run by Novartis Pharmaceuticals at 33 sites in United States.
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 10 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: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events and Serious Adverse Events (time frame: Up to 26 months). 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 NCT03078751, which also lists 2 linked publications.
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 11 Oct 2021.