Human Epidermal Growth Factor 2 Negative Carcinoma of BreastPhase 2MYMENCT01885013
Myocet + Cyclophosphamide + Metformin Vs Myocet + Cyclophosphamide in 1st Line Treatment of HER2 Neg. Metastatic Breast Cancer Patients
A Phase 2 study testing Metformin + Myocet + Cyclophosphamide and Myocet + Cyclophosphamide in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 25 sites in Italy.
Trial summary
This is a phase II comparative randomized clinical trial. Eligible patients will be randomized (1:1) to: Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide Statistical Considerations: In this randomized phase II study, the sample size was calculated basing on the primary end-point (PFS)… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- What is being tested?
- Metformin + Myocet + Cyclophosphamide and Myocet + Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 25 sitesItaly
- Study dates
- Sep 2010to May 2015
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed breast cancer
- Metastatic disease
- HER2 negative disease, as measured by IHC or FISH
- Non endocrine responsive disease (negative hormonal status or failure of endocrine therapy for MBC)
- Patients with measurable and/or non-measurable disease according to RECIST Criteria (Version 1.1)
- Homa Index calculated according to Matthews' formula
Show all 21Show fewer
- Prior endocrine therapy is allowed, in the adjuvant and/or metastatic setting
- Prior chemotherapy is allowed, only in adjuvant setting, provided it is terminated at least 12 months before study entry. Adjuvant anthracyclines are allowed if prior cumulative dose does not exceed 360 mg/m2 in case of epirubicin and 280 mg/m2 in case of doxorubicin. Adjuvant taxanes are allowed.
- Age 18-75 years
- Life expectancy of greater than 3 months
- ECOG performance status <2
- Patients must have normal organ and marrow function:
- leukocytes >=3,000/μL
- absolute neutrophil count >=1,500/μL
- platelets >=100,000/μL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <=1.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF)>= 50%
- The effects of liposomal doxorubicin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because anthracyclines as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Known diabetes (type 1 or 2)
- Currently on metformin, sulfonylureas, thiazolidenediones or insulin for any reason (these drugs alter insulin levels)
- Current or previous congestive heart failure, renal failure or liver failure; history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day
- Creatinine above upper limit of normal for institution, AST above 1.5 times upper limit or normal for institution (to reduce risk of lactic acidosis)
- Hypersensitivity or allergy to metformin
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening
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- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Myocet or other agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
ULSS n.8 Asolo Ospedale di Castelfranco
Asolo
Centro di Riferimento Oncologico CRO
Aviano
Ospedale S.Martino
Belluno
Azienda Ospedaliera "Antonio Cardarelli"
Campobasso
P.O. M. Bufalini
Cesena, FC
P.O. "SS. Annunziata"
Chieti
Presidio Ospedaliero E. Profili
Fabriano
Ospedale Civile degli Infermi
Faenza, RA
E.O. Galliera
Genova
Ospedale di Guastalla
Guastalla
Azienda per i Servizi Sanitari n.5 "Bassa Friulana"
Latisana
Presidio Ospedaliero "Vito Fazzi"
Lecce
Ospedale Umberto I
Lugo, RA
UO Oncologia Medica IRCCS IRST
Meldola (FC), FC, 47014
ULSS n.13 di Mirano
Mirano
Arcispedale S. Maria Nuova
Modena
Azienda Ospedaliera S. Salvatore di Pesaro
Pesaro
Ospedale S. Spirito
Pescara
Ospedale Civile di Piacenza
Piacenza
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone
Ospedale Civile Santa Maria delle Croci
Ravenna, RA
Arcispedale S. Maria Nuova
Reggio Emilia
Ospedale Civile degli Infermi
Rimini
IRCCS Centro di riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture
Ospedale Nuovo Regina Margherita
Roma
About this study
Official title: Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients
This is a phase II comparative randomized clinical trial.
Eligible patients will be randomized (1:1) to:
Read more
Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a period of 24 months and will be considered further 12-month of follow-up. The primary analysis of the study will be conducted in accordance with the "intention to treat" principle, the secondary analysis will be conducted in the "per protocol" population.
Read the detailed description
MULTICENTER, RANDOMIZED, COMPARATIVE STUDY OF MYOCET PLUS CYCLOPHOSPHAMIDE PLUS METFORMIN VERSUS MYOCET PLUS CYCLOPHOSPHAMIDE IN FIRST LINE TREATMENT OF HER2 NEGATIVE METASTATIC BREAST CANCER PATIENTS.
The aim of this study is to determine if the addition of metformin to the regime Myocet / Cyclophosphamide improves disease-free survival in patients with HER2-negative metastatic breast cancer.
The primary objective is the evaluation of the clinical efficacy of the combination of Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet / Cyclophosphamide, in terms of progression-free survival (PFS).
Clinical secondary objectives are:
- Objective response rate
- Overall survival
- Tolerability
- Progression-free survival, objective response rate and overall survival according to Homa Index levels.
Secondary biological endpoint is the characterization of the metabolic profile of patients (sensitivity in insulin levels).
Treatment Arm A (experimental treatment):
Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
- During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day.
Arm B (standard treatment):
Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days
Chemotherapy will be performed for 8 cycles.
The treatment will be continued until progression of disease.
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a period of 24 months and will be considered further 12-month of follow-up. The primary analysis of the study will be conducted in accordance with the "intention to treat" principle, the secondary analysis will be conducted in the "per protocol" population.
- Being tested
- Metformin + Myocet + Cyclophosphamide, Myocet + Cyclophosphamide
- Keywords
- HER2 negative, metastatic breast cancer, non endocrine responsive disease
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin + Myocet + CyclophosphamideDrug
Also called metformin, myocet, cyclofosfamide
Metformin + Myocet + Cyclophosphamide:
Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
- During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day.
Myocet + CyclophosphamideDrug
Also called myocet, cyclofosfamide
Myocet + Cyclophosphamide:
Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Myocet + Cyclophosphamide | Experimental | arm A : Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
* During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day. Receives: Drug: Metformin + Myocet + Cyclophosphamide |
| Myocet + Cyclophosphamide | Active comparator | arm B : Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days Receives: Drug: Myocet + Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Clinical efficacy of the combination of Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet / Cyclophosphamide, in terms of progression-free survival (PFS)
Measured: 42 months
Secondary outcomes (6)
Objective response rate
Objective Response Rate after treatment with Myocet/Cyclophosphamide/Metformin compared with after therapy with Myocet/Cyclophosphamide
Measured: 42 months
Overall survival
Overall survival after treatment with Myocet/Cyclophosphamide/Metformin compared with after therapy with Myocet/Cyclophosphamide
Measured: 42 months
Progression free survival as function of Homa Index levels
Clinical efficacy of the combination of Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet / Cyclophosphamide, in terms of progression-free survival (PFS) as function of Homa Index levels
Measured: 42 months
objective response rate as function of Homa Index levels
Objective Response Rate after treatment with Myocet/Cyclophosphamide/Metformin compared with after therapy with Myocet/Cyclophosphamide, as function of Homa Index levels
Measured: 42 months
overall survival as function of Homa Index levels
Overall survival after treatment with Myocet/Cyclophosphamide/Metformin compared with after therapy with Myocet/Cyclophosphamide, as function of Homa Index levels
Measured: 42 months
patient metabolic profile (metabolic syndrome)
Characterization of the metabolic profile of patients: sensitivity in insulin levels
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startSep 2010
- Primary completionMay 2015
- Study completionMay 2015
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 Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudies 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dino Amadori, MD, Principal investigator, IRST IRCCS, Meldola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885013
- Sponsor's protocol ID
- IRST174.04
- Other IDs
- 2009-014662-26, 2009
- Acronym
- MYME
- Status last verified
- Dec 2015
- First submitted
- 19 Jun 2013
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gennari A, Foca F, Zamarchi R, Rocca A, Amadori D, De Censi A, Bologna A, Cavanna L, Gianni L, Scaltriti L, Rossi E, Facchinetti A, Martini V, Bruzzi P, Nanni O. Insulin-like growth factor-1 receptor (IGF-1R) expression on circulating tumor cells (CTCs) and metastatic breast cancer outcome: results from the TransMYME trial. Breast Cancer Res Treat. 2020 May;181(1):61-68. doi: 10.1007/s10549-020-05596-4. Epub 2020 Mar 21.
PubMed 32200486
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients
- ClinicalTrials.gov ID
- NCT01885013
- Acronym / sponsor ID
- MYME / IRST174.04
- Keywords
- HER2 negative, metastatic breast cancer, non endocrine responsive disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jun 2013 (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.
This is a phase II comparative randomized clinical trial.
Eligible patients will be randomized (1:1) to:
Arm A: Myocet plus Cyclofosfamide plus Metformin Arm B: Myocet plus Cyclofosfamide
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a period of 24 months and will be considered further 12-month of follow-up. The primary analysis of the study will be conducted in accordance with the "intention to treat" principle, the secondary analysis will be conducted in the "per protocol" population.
Detailed description
MULTICENTER, RANDOMIZED, COMPARATIVE STUDY OF MYOCET PLUS CYCLOPHOSPHAMIDE PLUS METFORMIN VERSUS MYOCET PLUS CYCLOPHOSPHAMIDE IN FIRST LINE TREATMENT OF HER2 NEGATIVE METASTATIC BREAST CANCER PATIENTS.
The aim of this study is to determine if the addition of metformin to the regime Myocet / Cyclophosphamide improves disease-free survival in patients with HER2-negative metastatic breast cancer.
The primary objective is the evaluation of the clinical efficacy of the combination of Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet / Cyclophosphamide, in terms of progression-free survival (PFS).
Clinical secondary objectives are:
- Objective response rate
- Overall survival
- Tolerability
- Progression-free survival, objective response rate and overall survival according to Homa Index levels.
Secondary biological endpoint is the characterization of the metabolic profile of patients (sensitivity in insulin levels).
Treatment Arm A (experimental treatment):
Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
- During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day.
Arm B (standard treatment):
Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days
Chemotherapy will be performed for 8 cycles.
The treatment will be continued until progression of disease.
Statistical Considerations:
In this randomized phase II study, the sample size was calculated basing on the primary end-point (PFS) and assuming an error α = 10% (2-tailed) with a power of 80%.
To find an advantage of 4 months of median time to progression (6 months in the control arm B and 10 months in the experimental arm A) will be recruited 112 patients (98 events) for a period of 24 months and will be considered further 12-month of follow-up. The primary analysis of the study will be conducted in accordance with the "intention to treat" principle, the secondary analysis will be conducted in the "per protocol" population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin + Myocet + Cyclophosphamide | Experimental | Drug: Metformin + Myocet + Cyclophosphamidearm A : Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days. * During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day. |
| Myocet + Cyclophosphamide | Active comparator | Drug: Myocet + Cyclophosphamidearm B : Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed breast cancer
- Metastatic disease
- HER2 negative disease, as measured by IHC or FISH
- Non endocrine responsive disease (negative hormonal status or failure of endocrine therapy for MBC)
- Patients with measurable and/or non-measurable disease according to RECIST Criteria (Version 1.1)
Key exclusion criteria (9 listed)
- Known diabetes (type 1 or 2)
- Currently on metformin, sulfonylureas, thiazolidenediones or insulin for any reason (these drugs alter insulin levels)
- Current or previous congestive heart failure, renal failure or liver failure; history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day
- Creatinine above upper limit of normal for institution, AST above 1.5 times upper limit or normal for institution (to reduce risk of lactic acidosis)
- Hypersensitivity or allergy to metformin
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 |
|---|---|---|
| Metformin + Myocet + CyclophosphamideAlso: metformin, myocet, cyclofosfamideMetformin + Myocet + Cyclophosphamide: Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days. * During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day. | Drug | Metformin + Myocet + Cyclophosphamide |
| Myocet + CyclophosphamideAlso: myocet, cyclofosfamideMyocet + Cyclophosphamide: Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles | Drug | Myocet + Cyclophosphamide |
Primary outcome
progression-free survival (PFS)
Time frame: 42 months
Clinical efficacy of the combination of Myocet / Cyclophosphamide plus Metformin compared to treatment with only Myocet / Cyclophosphamide, in terms of progression-free survival (PFS)
6 secondary outcomes
Objective response rate
Time frame: 42 months
Overall survival
Time frame: 42 months
Progression free survival as function of Homa Index levels
Time frame: 42 months
objective response rate as function of Homa Index levels
Time frame: 42 months
overall survival as function of Homa Index levels
Time frame: 42 months
patient metabolic profile (metabolic syndrome)
Time frame: 42 months
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 1 Jan 2016.
- Derived from this study: PubMed 32200486Gennari A, Foca F, Zamarchi R, Rocca A, Amadori D, De Censi A, Bologna A, Cavanna L, Gianni L, Scaltriti L, Rossi E, Facchinetti A, Martini V, Bruzzi P, Nanni O. Insulin-like growth factor-1 receptor (IGF-1R) expression on circulating tumor cells (CTCs) and metastatic breast cancer outcome: results from the TransMYME trial. Breast Cancer Res Treat. 2020 May;181(1):61-68. doi: 10.1007/s10549-020-05596-4. Epub 2020 Mar 21.
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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.
Dino Amadori, MD principal investigator
IRST IRCCS, Meldola
25 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 Metformin + Myocet + Cyclophosphamide and Myocet + Cyclophosphamide in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 25 sites in Italy.
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 21 inclusion and 9 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. 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?
progression-free survival (PFS) (time frame: 42 months). 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 NCT01885013, 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 1 Jan 2016.