Evaluation of Medical Treatments in MBC Patients According Biological Subtype and Line of Treatments
NCT ID: NCT02284581
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2015-11-30
2025-12-31
Brief Summary
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The evolution of metastatic breast cancer has changed considerably in the last years with the approval of new drugs. In fact, already in 2003 Giordano et al showed that the prognosis of metastatic breast cancer patients was improved significantly from 1970's to 2000 with a median survival of 15 months in the early 1970's compared with 60 months in the last 1990's.
This significant survival gain was obtained with introduction of new drugs as hormonal, chemotherapeutic and biological agents. The greater availability of drugs has led to an increase in number of lines of treatment receiving by metastatic breast cancer patients. However, there are few published data on actual duration of metastatic breast cancer treatments. Moreover, there is no evidence to support a real impact on survival of treatments beyond the second-third line.
Recently, a retrospective analysis of about 199 metastatic breast cancer patients treated with chemotherapy showed that tumor subtype is associated with the duration and number of lines of chemotherapy (for example HER positive versus "triple-negative" patients) .
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Detailed Description
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The secondary Objectives are to evaluate overall survival according to duration and to number of lines of metastatic breast cancer treatments and to identify predictive factors of number of lines of treatment as for example age, treatment response, biological subtype, metastatic sites, etc and to identify possible elements of different treatment management between participating sites.
The aim of this retrospective and prospective study is to identify the duration of treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype and line of treatment in metastatic breast cancer patients.
An ancillary study will be conducted on part of population (HR+/HER2- patients newly diagnosed for mBC receiving first line CDk4/6 inhibitors).
For the ancillary study, it is expected to enroll at least 400 patients, who will be asked to fill in some questionnaires at the following visits, scheduled as per clinical practice:
* PROFFIT: baseline, day 1 cycle 3, day 1 cycle 5, every 6 months thereafter;
* Patient-reported outcomes (PRO): EORTC-QLQ-C30, FACT-B, COST-FACIT at baseline, day 1 cycle 3, day 1 cycle 5, every 6 months thereafter.
The ancillary study could evaluate:
* the impact of first line CDk4/6 inhibitors on HR+/HER2- metastatic breast cancer patients' financial toxicity
* retrospectively, the correlation between NLR and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line)
* the correlation between BMI and outcome in patients with breast cancer and in treatment with a CDk4/6 Inhibitor (as first line vs as second line).
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Retrospective cohort
All consecutive metastatic breast cancers patients treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from last contact with patient or death which ever event comes first retrospectively back until 1st of January 2000.
No interventions assigned to this group
Prospective cohort
All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy) from site activation to June 2023.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Prospective cohort All new consecutive metastatic breast cancers patients will be treated in the participating site with a first-line therapy (chemotherapy or hormonal therapy with or without biological therapy)from site activation to June 2023.
For the ancillary study
* Patients eligible for GIM 14 - BIO-META study
* HR+ HER2- patients newly diagnosed for mBC receiving CDk4/6 inhibitors as first-line or second-line treatment
* Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Consorzio Oncotech
OTHER
Responsible Party
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Principal Investigators
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Claudia Bighin, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS- Azienda Ospedaliera Universitaria San Martino-IST
Locations
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Centro di Riferimento Oncologico
Aviano, , Italy
A.O. Consorziale Policlinico di Bari
Bari, , Italy
A.O.U. Cagliari
Cagliari, , Italy
Fondazione del Piemonte per l'Oncologia - I.R.C.C.
Candiolo, , Italy
Azienda Ospedaliera Ospedale Sant'Anna
Como, , Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, , Italy
A.O.U. Sant'Anna
Ferrara, , Italy
Ospedale 'F. Spaziani'
Frosinone, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
A.O. Ospedale Civile di Legnano
Legnano, , Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, , Italy
ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli
Milan, , Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda
Milan, , Italy
A.O.R.N. "A. Cardarelli"
Napoli, , Italy
Azienda ospedaliero universitaria "Federico II"
Napoli, , Italy
Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'
Napoli, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Fondazione Maugeri IRCCS
Pavia, , Italy
A.O.U. Pisana
Pisa, , Italy
IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Istituto Regina Elena per lo studio e la cura dei tumori
Roma, , Italy
Policlinico Universitario A. Gemelli- DH Radiochemioterapia
Roma, , Italy
Policlinico Universitario Agostino Gemelli, IRCSS-Unità Medicina di Precisione in Senologia
Roma, , Italy
Policlinico Umberto I Università "La Sapienza" di Roma
Roma, , Italy
Azienda Ospedaliera S. Andrea
Roma, , Italy
Ospedale Sandro Pertini
Roma, , Italy
Asl Roma 1 - Ospedale Santo Spirito
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera S. Andrea
Sassari, , Italy
Ospedale Civile SS. Annunziata
Sassari, , Italy
Ospedale 'SS. Trinità'
Sora, , Italy
A.O.U. Città della Salute e della Scienza di Torino - Presidio San Lazzaro
Torino, , Italy
P.O. Martini - ASL TO1
Torino, , Italy
ASL Alessandria - Ospedale Civile Santi Antonio e Margherita
Tortona, , Italy
A.O.U. Santa Maria della Misericordia di Udine
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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Fabio Puglisi, MD
Role: primary
Stefania Stucci
Role: primary
Francesco Atzori
Role: primary
Filippo Montemurro, MD
Role: primary
Palma Pugliese, MD
Role: primary
Paola Vanella, MD
Role: primary
Angela Vaccaro, MD
Role: primary
Elena Collovà
Role: primary
Ugo De Giorgi
Role: primary
Grazia Arpino, MD
Role: primary
Michele De Laurentiis, MD
Role: primary
Antonino Musolino
Role: primary
Giancarlo Bisagni, MD
Role: primary
Francesco Cognetti, Md
Role: primary
Enrico Cortesi
Role: primary
Paolo Marchetti
Role: primary
Carlo Putzu
Role: primary
Antonio Pazzola
Role: primary
Angela Vaccaro, MD
Role: primary
Marco Galliano
Role: primary
References
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Cardoso F, Senkus-Konefka E, Fallowfield L, Costa A, Castiglione M; ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v15-9. doi: 10.1093/annonc/mdq160. No abstract available.
Schnipper LE, Smith TJ, Raghavan D, Blayney DW, Ganz PA, Mulvey TM, Wollins DS. American Society of Clinical Oncology identifies five key opportunities to improve care and reduce costs: the top five list for oncology. J Clin Oncol. 2012 May 10;30(14):1715-24. doi: 10.1200/JCO.2012.42.8375. Epub 2012 Apr 3. No abstract available.
Seah DS, Luis IV, Macrae E, Sohl J, Litsas G, Winer EP, Lin NU, Burstein HJ. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw. 2014 Jan;12(1):71-80. doi: 10.6004/jnccn.2014.0008.
Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ; Panel members. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011 Aug;22(8):1736-47. doi: 10.1093/annonc/mdr304. Epub 2011 Jun 27.
Conte B, Fabi A, Poggio F, Blondeaux E, Dellepiane C, D'Alonzo A, Buono G, Arpino G, Magri V, Naso G, Presti D, Mura S, Fontana A, Cognetti F, Molinelli C, Pastorino S, Bighin C, Miglietta L, Boccardo F, Lambertini M, Del Mastro L; Gruppo Italiano Mammella (GIM) study group. T-DM1 Efficacy in Patients With HER2-positive Metastatic Breast Cancer Progressing After a Taxane Plus Pertuzumab and Trastuzumab: An Italian Multicenter Observational Study. Clin Breast Cancer. 2020 Apr;20(2):e181-e187. doi: 10.1016/j.clbc.2019.09.001. Epub 2019 Nov 14.
Other Identifiers
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GIM14-BIOMETA
Identifier Type: -
Identifier Source: org_study_id
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