Metastatic Breast CancerPhase 2VinoMetroNCT03007992
Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
A Phase 2 study testing Vinorelbine in people with Metastatic Breast Cancer, run by Johannes Gutenberg University Mainz at 8 sites in Germany.
Trial summary
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Vinorelbine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 8 sitesGermany
- Study dates
- Dec 2016to 2 Mar 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
- Written (personally dated and signed) informed consent prior to the performance of any trial specific procedure
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or the follow-up schedule
- Female patient ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, which the investigator assesses as being stable at time of screening
- Estimated life expectancy ≥ 16 weeks
- Histologically confirmed adenocarcinoma of the breast
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- Documented locally advanced or metastatic disease, previously untreated by palliative chemotherapy and not amenable to any curative treatment
- Hormone receptor positive disease determined by ≥ 1% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumour or on a metastatic site
- HER2-negative disease assessed by 0-1+ immuno-histochemistry (IHC) or 2+ IHC with negative fluorescence in situ hybridization (FISH) or CISH) on the primary tumour or on a metastatic site
- Availability of archival (from the most recently obtained sample) or fresh tumour tissue from patients included in the trial for the analysis of relevant metronomic biomarkers; one tumour block (preferred) or a minimum of 12 (recommended: 15) unstained slides to be provided
- Relapse ≤ 12 months from end of adjuvant hormonal therapy or pro¬gres¬sion during/after ≥ 1 line of endocrine therapy in the metastatic set¬ting and/or no longer candidate for further endocrine therapy
- Prior (neo-)adjuvant chemotherapy is allowed, if the interval between end of chemotherapy and date of registration is > 12 months
- Prior treatment with everolimus and/or palbociclib in the frame of hormonal therapy is allowed
- Complete staging before registration (CT/MRI thorax and CT/MRI abdomen/pelvis ≤ 28 days before registration; bone scan ≤ 3 months before registration)
- Presence of ≥ 1 measurable lesion as per RECIST 1.1, which has not been previously irradiated
- Adequate bone marrow, hepatic and renal function as defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Haemoglobin ≥ 10 g/dL
- Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (≤ 3 x ULN in case of liver metasta¬s¬es)
- Liver transaminases ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metasta¬s¬es)
- Alkaline phosphatase ≤ 5 x ULN
- Creatinine ≤ 1.5 x ULN (creatinine clearance should be assessed based on the Cockcroft-Gault-formula in case of borderline values and should then be ≥ 50 ml/min)
- Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is minimised; reliable contraception comprises sexual abstinence, male sterilization or double barrier methods (e.g. a combination of male condom with diaphragm).
- Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
- Ability of the patient to understand the character and the individual consequences of this clinical trial.
Who cannot join
- No recovery to ≤ Grade (G)1 side effects (exception: alopecia) of any prior anti-neoplastic treatment
- Aggressive locally advanced or metastatic breast cancer disease requiring systemic combination therapy
- Known or suspected central nervous system (CNS) and/or leptomeningeal involvement
- Current peripheral neuropathy ≥ G2
- Dysphagia or inability to swallow oral medication
- Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
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- Other serious illness or medical condition, such as but not limited to:
- Clinically significant cardiac disease or impaired cardiac function (such as: congestive heart failure requiring treatment (NYHA ≥ II); eft ventricular ejection fraction (LVEF) < 50%; significant cardiac arrhythmia; atrial fibrillation; conduction abnormality such as congenital long QT syndrome or high grade/complete atrioventricular (AV)-blockage; acute coronary syndrome including myocardial infarction, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if < 3 months prior to registration; QTcF > 480 msec at screening)
- Uncontrolled hypertension (> 140/100 mmHg at rest (average of 3 consecutive readings))
- Unstable diabetes mellitus
- Uncontrolled hypercalcemia
- Clinically significant active infections (current or within the last 2 weeks prior to registration)
- Previous organ allograft
- Prior treatment with vinorelbine or other vinca alkaloids
- Concomitant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, fulvestrant) for advanced breast cancer
- Concomitant use of yellow-fever vaccination or other attenuated life vaccine
- Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable)
- Necessity to undergo long-term oxygen therapy
- Major surgery ≤ 28 days prior to registration and/or no recovery from side effects of such therapy to baseline condition or ≤ G1
- Radiotherapy ≤ 28 days prior to registration, no recovery from side effects of such therapy to baseline condition or ≤ G1 and/or irradiation of ≥ 30% of bone marrow
- Known hypersensitivity to vinca alkaloids, soy, peanut or any of the excipients contained in the oral vinorelbine capsules
- Participation in another clinical trial with any investigational drug ≤ 30 days prior to registration
- History of another malignancy within the past 5 years prior to registration, except cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix
- Pregnant or nursing (lactating) woman
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Universitätsklinikum Düsseldorf, Frauenklinik
Düsseldorf, 40225
Klinikum Frankfurt-Höchst Klinik für Gynäkologie und Geburtshilfe - Operative und konservative Gynäkologie, Gynäkologische Onkologie, Pränataldiagnostik, Geburtshilfe
Frankfurt am Main, 65929
Universitätsklinikum Halle (Saale), Klinik und Poliklinik für Gynäkologie
Halle, 06120
Onkologische Schwerpunktpraxis Dr. Karcher, Dr. Fuxius, Dr. Debatin
Heidelberg, 69115
Universitätsklinikum des Saarlandes, Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin
Homburg, 66421
Universitätsmedizin Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit
Mainz, 55131
Klinikum der LMU München, Brustzentrum
München, 80377
Schwerpunktpraxis für Hämatologie und Onkologie Ravensburg
Ravensburg, 88212
About this study
Official title: Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.
Read the detailed description
In terms of the chronic nature of advanced/metastatic breast cancer, there is a high medical need for new treatment options after failure of hormonal treatment that prolong the interval to the start of intensive cytotoxic therapy, which is commonly associated with impaired quality of life (QoL) and potentially serious side effects. In this respect, metronomic treatment with daily administration of oral vinorelbine could provide an efficacious treatment option with limited toxicities.
Accordingly, this national, multi-centre, open-label, single-arm phase II trial aims to investigate a truly metronomic schedule with daily oral vinorelbine in HR+/HER2-patients with metastatic breast cancer resistant to endocrine therapy, by assessing efficacy and safety. Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
In the course of the study, the following interim and final analyses will be done:
- 1st interim analysis (safety): This analysis will be performed on the basis of 10 patients, who were initially included into the study and who are eligible for safety evaluation; frequency statistics of (serious) adverse events will be analysed. ii) 2nd interim analysis (efficacy): This analysis will be performed at the completion of the 1st Simon stage. iii) Final analysis (complete): This analysis will be performed after completion of the follow-up phase (6 months of follow-up after Last Patient Last Treatment).
- Conditions
- Metastatic Breast Cancer
- Being tested
- Vinorelbine
- Keywords
- Breast cancer, Vinorelbine, Metronomic chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Navelbine® soft capsules
Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine Oral | Experimental | Test product: Navelbine® 20 mg / 30 mg soft capsules Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
The primary endpoint is the determination of the Clinical Benefit Rate (CBR) at 24 weeks after start of treatment. The response to treatment is measured by computer tomography (CT) or magnetic resonance imaging (MRI) for measurable lesions and evaluation for non-measurable lesions at 24 weeks after start of treatment.
Measured: 24 weeks after start of treatment.
Secondary outcomes (12)
Overall response rate (ORR)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Disease control rate (DCR)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Duration of disease control (DoDC)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Duration of stable disease (DoSD)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Duration of response (DoR)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Progression-free survival (PFS)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Time to treatment failure (TTF)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Overall survival (OS)
Statistical evaluation of above mentioned parameter for each patient measured in duration of month
Measured: 6 months after last patient last treatment
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Determination of frequency and severity of (serious) adverse events and the number of laboratory values worsening from baseline based on the Common Toxicity Criteria (CTC) Grade; other safety data (e.g. vital signs and special tests) will be considered as appropriate
Measured: 6 months after last patient last treatment
Patient's symptoms and health-related quality of life
Evaluation of the Global Health Status/QoL on the basis of the Eastern Cooperative Oncology Group (EORTC) quality of life questionnaire (QLQ)-C30 questionnaire
Measured: 6 months after last patient last treatment
Histopathological parameters
Analysis of tumour tissue biomarkers before the start of study treatment and upon progression: histopathological analyses including qualitative assessments of tumor-infiltrating lymphocytes (TIL) involving the evaluation of regulatory T cells (Treg), cluster of differentiation 8 (CD8), CD20 and immune checkpoint parameters (e.g. Programmed Death-Ligand 1 (PD-L1)); additionally, markers like vascular endothelial growth factor-A (VEGF-A), thrombospondin-1 (TSP-1) and hypoxia inducible factor-1 (HIF-1) will be evaluated
Measured: before start of treatment and upon progression, assessed up to 6 months after last patient last treatment
Biomarker profiles
Analysis of blood biomarkers before the start of study treatment, during the treatment period and upon progression: assessment of blood biomarkers, such as CD4+ CD25+ Forkhead-Box-Protein P3 (FOXP3+) Treg, T and B lymphocytes, natural killer (NK) cells and monocytes, hypoxia inducible factor-1 (HIF-1), vascular endothelial growth factor (VEGF), thrombospondin-1 (TSP-1), and to evaluate potential correlations of biomarker expression and clinical outcomes (response, PFS, OS)
Measured: before start of treatment, during treatment period and upon progression, assessed up to 6 months after last patient last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion2 Mar 2019
- Study completion2 Mar 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Pharma GmbH
- Responsible party
- Principal investigator, Marcus Schmidt, MD, Johannes Gutenberg University Mainz
- Investigators
- Marcus Schmidt, Univ.-Prof. Dr. med., Principal investigator, Universitätsmedizin Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007992
- Sponsor's protocol ID
- 2015-007
- Acronym
- VinoMetro
- Status last verified
- Feb 2019
- First submitted
- 15 Dec 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krajnak S, Decker T, Schollenberger L, Rose C, Ruckes C, Fehm T, Thomssen C, Harbeck N, Schmidt M. Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy: VinoMetro-AGO-B-046. J Cancer Res Clin Oncol. 2021 Nov;147(11):3391-3400. doi: 10.1007/s00432-021-03599-2. Epub 2021 Mar 20.
PubMed 33743073
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy
- ClinicalTrials.gov ID
- NCT03007992
- Acronym / sponsor ID
- VinoMetro / 2015-007
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, Vinorelbine, Metronomic chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Pierre Fabre Pharma GmbH
- Study start
- Dec 2016 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.
Detailed description
In terms of the chronic nature of advanced/metastatic breast cancer, there is a high medical need for new treatment options after failure of hormonal treatment that prolong the interval to the start of intensive cytotoxic therapy, which is commonly associated with impaired quality of life (QoL) and potentially serious side effects. In this respect, metronomic treatment with daily administration of oral vinorelbine could provide an efficacious treatment option with limited toxicities.
Accordingly, this national, multi-centre, open-label, single-arm phase II trial aims to investigate a truly metronomic schedule with daily oral vinorelbine in HR+/HER2-patients with metastatic breast cancer resistant to endocrine therapy, by assessing efficacy and safety. Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
In the course of the study, the following interim and final analyses will be done:
- 1st interim analysis (safety): This analysis will be performed on the basis of 10 patients, who were initially included into the study and who are eligible for safety evaluation; frequency statistics of (serious) adverse events will be analysed. ii) 2nd interim analysis (efficacy): This analysis will be performed at the completion of the 1st Simon stage. iii) Final analysis (complete): This analysis will be performed after completion of the follow-up phase (6 months of follow-up after Last Patient Last Treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine Oral | Experimental | Drug: VinorelbineTest product: Navelbine® 20 mg / 30 mg soft capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Written (personally dated and signed) informed consent prior to the performance of any trial specific procedure
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or the follow-up schedule
- Female patient ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, which the investigator assesses as being stable at time of screening
- Estimated life expectancy ≥ 16 weeks
Key exclusion criteria (24 listed)
- No recovery to ≤ Grade (G)1 side effects (exception: alopecia) of any prior anti-neoplastic treatment
- Aggressive locally advanced or metastatic breast cancer disease requiring systemic combination therapy
- Known or suspected central nervous system (CNS) and/or leptomeningeal involvement
- Current peripheral neuropathy ≥ G2
- Dysphagia or inability to swallow oral medication
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 |
|---|---|---|
| VinorelbineAlso: Navelbine® soft capsulesOral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment. | Drug | Vinorelbine Oral |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: 24 weeks after start of treatment.
The primary endpoint is the determination of the Clinical Benefit Rate (CBR) at 24 weeks after start of treatment. The response to treatment is measured by computer tomography (CT) or magnetic resonance imaging (MRI) for measurable lesions and evaluation for non-measurable lesions at 24 weeks after start of treatment.
12 secondary outcomes
Overall response rate (ORR)
Time frame: 6 months after last patient last treatment
Disease control rate (DCR)
Time frame: 6 months after last patient last treatment
Duration of disease control (DoDC)
Time frame: 6 months after last patient last treatment
Duration of stable disease (DoSD)
Time frame: 6 months after last patient last treatment
Duration of response (DoR)
Time frame: 6 months after last patient last treatment
Progression-free survival (PFS)
Time frame: 6 months after last patient last treatment
Time to treatment failure (TTF)
Time frame: 6 months after last patient last treatment
Overall survival (OS)
Time frame: 6 months after last patient last treatment
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months after last patient last treatment
Patient's symptoms and health-related quality of life
Time frame: 6 months after last patient last treatment
Histopathological parameters
Time frame: before start of treatment and upon progression, assessed up to 6 months after last patient last treatment
Biomarker profiles
Time frame: before start of treatment, during treatment period and upon progression, assessed up to 6 months after last patient last treatment
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 12 Aug 2019.
- Derived from this study: PubMed 33743073Krajnak S, Decker T, Schollenberger L, Rose C, Ruckes C, Fehm T, Thomssen C, Harbeck N, Schmidt M. Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy: VinoMetro-AGO-B-046. J Cancer Res Clin Oncol. 2021 Nov;147(11):3391-3400. doi: 10.1007/s00432-021-03599-2. Epub 2021 Mar 20.
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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.
Marcus Schmidt, Univ.-Prof. Dr. med. principal investigator
Universitätsmedizin Mainz, Klinik und Poliklinik für Geburtshilfe und Frauengesundheit
8 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 Vinorelbine in people with Metastatic Breast Cancer, run by Johannes Gutenberg University Mainz at 8 sites in Germany.
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 26 inclusion and 24 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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?
Clinical Benefit Rate (CBR) (time frame: 24 weeks after start of treatment.). 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 NCT03007992, 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 12 Aug 2019.