Myocet + Cyclophosphamide + Metformin Vs Myocet + Cyclophosphamide in 1st Line Treatment of HER2 Neg. Metastatic Breast Cancer Patients
MYME
Phase II Comparative Study of Myocet Plus Cyclophosphamide in First Line Treatment of HER2 Negative Metastatic Breast Patients
2 other identifiers
interventional
126
1 country
25
Brief 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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJanuary 1, 2016
December 1, 2015
4.7 years
June 19, 2013
December 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
42 months
Secondary Outcomes (6)
Objective response rate
42 months
Overall survival
42 months
Progression free survival as function of Homa Index levels
42 months
objective response rate as function of Homa Index levels
42 months
overall survival as function of Homa Index levels
42 months
- +1 more secondary outcomes
Study Arms (2)
Metformin + Myocet + Cyclophosphamide
EXPERIMENTALarm 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 COMPARATORarm 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
Interventions
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 + 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
Eligibility Criteria
You may qualify if:
- 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
- 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
- +6 more criteria
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
P.O. M. Bufalini
Cesena, FC, Italy
UO Oncologia Medica IRCCS IRST
Meldola (FC), FC, 47014, Italy
Ospedale Civile degli Infermi
Faenza, RA, Italy
Ospedale Umberto I
Lugo, RA, Italy
Ospedale Civile Santa Maria delle Croci
Ravenna, RA, Italy
ULSS n.8 Asolo Ospedale di Castelfranco
Asolo, Italy
Centro di Riferimento Oncologico CRO
Aviano, Italy
Ospedale S.Martino
Belluno, Italy
Azienda Ospedaliera "Antonio Cardarelli"
Campobasso, Italy
P.O. "SS. Annunziata"
Chieti, Italy
Presidio Ospedaliero E. Profili
Fabriano, Italy
E.O. Galliera
Genova, Italy
Ospedale di Guastalla
Guastalla, Italy
Azienda per i Servizi Sanitari n.5 "Bassa Friulana"
Latisana, Italy
Presidio Ospedaliero "Vito Fazzi"
Lecce, Italy
ULSS n.13 di Mirano
Mirano, Italy
Arcispedale S. Maria Nuova
Modena, Italy
Azienda Ospedaliera S. Salvatore di Pesaro
Pesaro, Italy
Ospedale S. Spirito
Pescara, Italy
Ospedale Civile di Piacenza
Piacenza, Italy
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale Civile degli Infermi
Rimini, Italy
IRCCS Centro di riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Italy
Ospedale Nuovo Regina Margherita
Roma, Italy
Related Publications (1)
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.
PMID: 32200486DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dino Amadori, MD
IRST IRCCS, Meldola
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 24, 2013
Study Start
September 1, 2010
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
January 1, 2016
Record last verified: 2015-12