Breast CancerPhase 2CORALLEENNCT03248427
Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.
A Phase 2 study testing Ribociclib, Letrozole 2.5mg and Doxorubicin in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 21 sites in Spain.
Trial summary
CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib, Letrozole 2.5mg and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 21 sitesSpain
- Study dates
- 13 Jul 2017to 20 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form prior to any study-specific procedure.
- Female patients.
- Post-menopausal status and age ≥18 years.
- Histologically confirmed invasive breast carcinoma, with all the following characteristics:
- Primary tumor ≥ 2cm in largest diameter as measured by breast MRI
- Stage I to stage IIIA breast cancer
Show all 15Show fewer
- No evidence of distant metastasis (M0)
- Breast cancer eligible for primary surgery.
- Available pre-treatment FFPE core (Tru-cut) biopsy evaluable for PAM50 or possibility to obtain one. Minimal sample requirements are to have at least 2 tumor cylinders with a minimal tissue surface of 10 mm2 tissue, containing at least 10% tumor cells and having enough tissue to do at least 2 cuts of 10 micrometers each.
- Luminal B subtype as per PAM50 analysis of pre-treatment sample.
- ER-positive and/or PgR-positive and HER2-negative tumor by ASCO/CAP guidelines assessed locally.
- In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be ≥ 2 cm and designated the "target" lesion for all subsequent tumor evaluations and HR+/HER2-negative status must be documented in all the tumor foci.
- ECOG performance status of 0 or 1.
- Adequate hematological, renal and hepatic function.
- Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol.
Who cannot join
- Any prior treatment for primary invasive breast cancer.
- Inoperable locally advanced or inflammatory (i.e., inoperable Stage III) breast cancer.
- Metastatic (Stage IV) breast cancer.
- Bilateral invasive breast cancer.
- Multicentric breast cancer, defined as the presence of two or more foci of cancer in different quadrants of the same breast.
- Patients who have undergone sentinel lymph node biopsy prior to study treatment.
Show all 38Show fewer
- Inability or unwillingness to swallow pills.
- Malabsorption syndrome or other condition that would interfere with enteric absorption of study drugs.
- Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.
- Patient with a Child-Pugh score B or C.
- Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
- History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) or symptomatic pericarditis within 12 months prior to screening.
- History of documented congestive heart failure (New York Heart Association functional classification III-IV).
- Documented cardiomyopathy.
- Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).
- Clinical significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block)
- Long QT Syndrome or family history of idiopathic sudden death or congenital long QT syndrome.
- On screening 12-lead ECG, any of the following cardiac parameters (defined as the mean of triplicate ECGs: bradycardia (resting heart rate < 50), tachycardia (resting heart rate > 90), PR interval > 220 msec, QRS interval >109 msec, or QTcF interval ≥450 msec (using Fridericia's correction).
- Uncontrolled hypertension (Systolic blood pressure >160 mmHg or <90 mmHg and/or diastolic >100 mmHg).
- Active infection requiring intravenous (IV) antibiotics.
- Symptomatic hypercalcemia despite adequate management.
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Known human immunodeficiency virus (HIV) infection.
- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may compromise compliance with the protocol, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.
- Significant traumatic injury within 3 weeks prior to initiation of study treatment.
- Major surgical procedure (not including minor procedures such as lymph node biopsy, tumor core biopsy, fine needle aspiration) within 4 weeks prior to initiation of study treatment or not fully recovered from any side effects of previous procedures.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- History of other malignancy within 5 years prior to screening, except for appropriately treated basal or squamous cell carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
- Hormone replacement therapy stopped less than 2 weeks before treatment start.
- Currently receiving or has received systemic corticosteroids until 2 weeks before treatment start or who have not fully recovered from side effects of such treatment. Following corticosteroid uses are permitted: single doses, topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular)
- Known hypersensitivity to any of the excipients of ribociclib, letrozole, doxorubicin, cyclophosphamide or paclitaxel.
- Patients currently on following medications, which cannot be interrupted 7 days prior treatment start:
- Any prohibited medication as per letrozole, doxorubicin, cyclophosphamide, or paclitaxel label.
- Herbal preparations/medications, dietary supplements.
- Medications that have a known risk to prolong the QT interval or cause Torsades de Pointe.
- Medications with a narrow therapeutic window and predominantly metabolized through CYP3A4/5.
- Strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit and Seville oranges.
- Warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin or fondaparinux is allowed.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites
Hospital Clinic de Barcelona
Barcelona
Hospital General de Catalunya
Barcelona
Hospital Universitari Vall d' Hebron
Barcelona
Institut Català d'Oncologia l'Hospitalet
Barcelona
Hospital San Pedro de Alcántara
Cáceres
Consorcio Hospitalario Provincial de Castellón
Castelló
Fundació Privada Hospital Asil de Granollers
Granollers
Centro Integral Oncologico Clara Campal
Madrid
Centro Oncológico MD Anderson International España
Madrid
Hospital Quirón Madrid
Madrid
Hospital Rey Juan Carlos
Madrid
Hospital Universitario 12 de octubre
Madrid
Hospital Universitario Fundación de Alcorcón
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitari Son Espases
Palma
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital Virgen del Rocío
Seville
Hospital Virgen Macarena
Seville
Fundación Instituto Valenciano de Oncología
Valencia
Hospital Clínico Universitario de Valencia
Valencia
Hospital Universitari Arnau de Vilanova de València
Valencia
About this study
Official title: CORALLEEN: A Phase 2 Clinical Trial of Multi-agent Chemotherapy or Letrozole Plus Ribociclib (LEE011) as Neoadjuvant Treatment for Postmenopausal Patients With Luminal B/HER2-negative Breast Cancer.
CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.
Read the detailed description
This is a parallel, two-arm, randomized 1:1, stratified by tumor size and nodal involvement, open-label, multicenter, exploratory study in postmenopausal women with primary operable HR+/HER2-negative Luminal B breast cancer according to PAM50 intrinsic subtype to evaluate the clinical benefit and biological effects of ribociclib combined with letrozole.
The primary trial objective is to evaluate the ability of each treatment strategy to provide ROR-low score at surgery.
Luminal B patients will be randomized 1:1 to either letrozole plus ribociclib or chemotherapy.Two weeks after the first administration of the assigned treatment, patients will undergo a biopsy to assess early biological response to treatment, at Ki67 protein and gene expression level. After finalization of the assigned neoadjuvant treatment, patients will undergo surgery.
The primary endpoint, Rate of ROR-low (at surgery) after neoadjuvant treatment, according to the Prosigna test will be centrally assessed.
Baseline, Day 15 and post-treatment (surgical) primary breast tumor tissue samples should be available for each patient for molecular characterization A post-surgery visit will be performed within 28 days (7 days) from surgery, and will mark the end of the study for that patient
- Conditions
- Breast Cancer
- Being tested
- Ribociclib, Letrozole 2.5mg, Doxorubicin, Cyclophosphamide, Paclitaxel
- Keywords
- Breast Cancer, Neoadjuvant, Luminal B tumors, Ribociclib
- 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 flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.
Letrozole 2.5mgDrug
Daily continuous
DoxorubicinDrug
60 mg/m2 as a continuous IV perfusion
CyclophosphamideDrug
600 MG/M2 in a 30 minutes IV infusion
PaclitaxelDrug
80 mg/m2, in one hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib + Letrozol | Experimental | Ribociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles Receives: Drug: Ribociclib; Drug: Letrozole 2.5mg |
| Chemotherapy | Other | Chemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks. Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ROR-low according to the Prosigna test.
Rate of ROR-low after neoadjuvant treatment at surgery, according to the Prosigna test,as per central assessment
Measured: 24 weeks
Secondary outcomes (7)
Tumor Overall response rate (ORR)
Tumor overall objective response rate (ORR), defined as the sum of Partial Responses (PR) and Complete Responses (CR) according to RECIST v1.1, as per Investigator's assessments by breast MRI.
Measured: 24 weeks
pCR in the breast and axillary lymph nodes
pCR is defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination.
Measured: 24 weeks
PEPI Score
Preoperative endocrine prognostic index (PEPI) score in the ribociclib plus letrozole treatment arm compared to historical values
Measured: 24 weeks
Residual Cancer Burden (RCB)
Rate of residual cancer burden (RCB) score 0 or 1 (RCB0/1) after neoadjuvant treatment, according to the MD Anderson Cancer Center procedures, as per central assessment.
Measured: 24 weeks
Rate of breast conserving surgery (BCS)
Rate of breast conserving surgery
Measured: 24 weeks
Decrease in Ki67 in both treatment arms.
Decrease in Ki67 in both treatment arms.
Measured: At baseline, in week 2, and pre-surgery
Incidence, duration and severity of Adverse Events (AEs)
Incidence, duration and severity of Adverse Events (AEs) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 4.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start13 Jul 2017
- Primary completion10 Jun 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Aleix Prat, PhD, Principal investigator, H.Clinic de Barcelona/Joaquin Gavilá, MD, Principal investigator, Fundación Instituto Valenciano de Oncología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248427
- Sponsor's protocol ID
- SOLTI1402
- Acronym
- CORALLEEN
- Status last verified
- Mar 2021
- First submitted
- 3 Jul 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villacampa G, Falato C, Pare L, Hernando C, Arumi M, Saura C, Gomez G, Munoz M, Gil-Gil M, Izarzugaza Y, Ferrer N, Najera-Zuloaga J, Montano A, Ciruelos E, Gonzalez-Santiago S, Villagrasa P, Gavila J, Prat A, Pascual T. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial. Eur J Cancer. 2022 Oct;174:232-242. doi: 10.1016/j.ejca.2022.07.028. Epub 2022 Sep 5.
PubMed 36067616Prat A, Saura C, Pascual T, Hernando C, Munoz M, Pare L, Gonzalez Farre B, Fernandez PL, Galvan P, Chic N, Gonzalez Farre X, Oliveira M, Gil-Gil M, Arumi M, Ferrer N, Montano A, Izarzugaza Y, Llombart-Cussac A, Bratos R, Gonzalez Santiago S, Martinez E, Hoyos S, Rojas B, Virizuela JA, Ortega V, Lopez R, Celiz P, Ciruelos E, Villagrasa P, Gavila J. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2020 Jan;21(1):33-43. doi: 10.1016/S1470-2045(19)30786-7. Epub 2019 Dec 11.
PubMed 31838010
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORALLEEN: A Phase 2 Clinical Trial of Multi-agent Chemotherapy or Letrozole Plus Ribociclib (LEE011) as Neoadjuvant Treatment for Postmenopausal Patients With Luminal B/HER2-negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT03248427
- Acronym / sponsor ID
- CORALLEEN / SOLTI1402
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant, Luminal B tumors, Ribociclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- SOLTI Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 14 Aug 2017 (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.
CORALLEEN is a two-arm, randomized, multicentric study in postmenopausal women with primary HR+/HER2 negative Luminal B breast cancer that will explore if the combination of ribociclib with letrozole offers clinical benefit at least comparable to that of standard chemotherapy.
Detailed description
This is a parallel, two-arm, randomized 1:1, stratified by tumor size and nodal involvement, open-label, multicenter, exploratory study in postmenopausal women with primary operable HR+/HER2-negative Luminal B breast cancer according to PAM50 intrinsic subtype to evaluate the clinical benefit and biological effects of ribociclib combined with letrozole.
The primary trial objective is to evaluate the ability of each treatment strategy to provide ROR-low score at surgery.
Luminal B patients will be randomized 1:1 to either letrozole plus ribociclib or chemotherapy.Two weeks after the first administration of the assigned treatment, patients will undergo a biopsy to assess early biological response to treatment, at Ki67 protein and gene expression level. After finalization of the assigned neoadjuvant treatment, patients will undergo surgery.
The primary endpoint, Rate of ROR-low (at surgery) after neoadjuvant treatment, according to the Prosigna test will be centrally assessed.
Baseline, Day 15 and post-treatment (surgical) primary breast tumor tissue samples should be available for each patient for molecular characterization A post-surgery visit will be performed within 28 days (7 days) from surgery, and will mark the end of the study for that patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribociclib + Letrozol | Experimental | Drug: Ribociclib, Drug: Letrozole 2.5mgRibociclib: 600mg, 3-weeks-on/-week-off treatment Letrozole: 2.5mg daily; Six 28 days cycles |
| Chemotherapy | Other | Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: PaclitaxelChemotherapy treatment will consist of four cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days) followed by weekly paclitaxel during 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed Informed Consent Form prior to any study-specific procedure.
- Female patients.
- Post-menopausal status and age ≥18 years.
- Histologically confirmed invasive breast carcinoma, with all the following characteristics:
- Breast cancer eligible for primary surgery.
Key exclusion criteria (38 listed)
- Any prior treatment for primary invasive breast cancer.
- Inoperable locally advanced or inflammatory (i.e., inoperable Stage III) breast cancer.
- Metastatic (Stage IV) breast cancer.
- Bilateral invasive breast cancer.
- Multicentric breast cancer, defined as the presence of two or more foci of cancer in different quadrants of the same breast.
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 flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle. | Drug | Ribociclib + Letrozol |
| Letrozole 2.5mgDaily continuous | Drug | Ribociclib + Letrozol |
| Doxorubicin60 mg/m2 as a continuous IV perfusion | Drug | Chemotherapy |
| Cyclophosphamide600 MG/M2 in a 30 minutes IV infusion | Drug | Chemotherapy |
| Paclitaxel80 mg/m2, in one hour IV infusion | Drug | Chemotherapy |
Primary outcome
Rate of ROR-low according to the Prosigna test.
Time frame: 24 weeks
Rate of ROR-low after neoadjuvant treatment at surgery, according to the Prosigna test,as per central assessment
7 secondary outcomes
Tumor Overall response rate (ORR)
Time frame: 24 weeks
pCR in the breast and axillary lymph nodes
Time frame: 24 weeks
PEPI Score
Time frame: 24 weeks
Residual Cancer Burden (RCB)
Time frame: 24 weeks
Rate of breast conserving surgery (BCS)
Time frame: 24 weeks
Decrease in Ki67 in both treatment arms.
Time frame: At baseline, in week 2, and pre-surgery
Incidence, duration and severity of Adverse Events (AEs)
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 36067616Villacampa G, Falato C, Pare L, Hernando C, Arumi M, Saura C, Gomez G, Munoz M, Gil-Gil M, Izarzugaza Y, Ferrer N, Najera-Zuloaga J, Montano A, Ciruelos E, Gonzalez-Santiago S, Villagrasa P, Gavila J, Prat A, Pascual T. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial. Eur J Cancer. 2022 Oct;174:232-242. doi: 10.1016/j.ejca.2022.07.028. Epub 2022 Sep 5.
- Derived from this study: PubMed 31838010Prat A, Saura C, Pascual T, Hernando C, Munoz M, Pare L, Gonzalez Farre B, Fernandez PL, Galvan P, Chic N, Gonzalez Farre X, Oliveira M, Gil-Gil M, Arumi M, Ferrer N, Montano A, Izarzugaza Y, Llombart-Cussac A, Bratos R, Gonzalez Santiago S, Martinez E, Hoyos S, Rojas B, Virizuela JA, Ortega V, Lopez R, Celiz P, Ciruelos E, Villagrasa P, Gavila J. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2020 Jan;21(1):33-43. doi: 10.1016/S1470-2045(19)30786-7. Epub 2019 Dec 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aleix Prat, PhD principal investigator
H.Clinic de Barcelona/
Joaquin Gavilá, MD principal investigator
Fundación Instituto Valenciano de Oncología
21 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, Letrozole 2.5mg and Doxorubicin in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 21 sites in Spain.
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 15 inclusion and 38 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of ROR-low according to the Prosigna test. (time frame: 24 weeks). 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 NCT03248427, 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 17 Mar 2021.