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Metastatic Breast CancerBIO-METANCT02284581

Evaluation of Medical Treatments in MBC Patients According Biological Subtype and Line of Treatments

An observational study of Metastatic Breast Cancer, run by Consorzio Oncotech at 35 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about 13.000 women die every year for this disease . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
How many people
10,000 participants
Where
35 sitesItaly
Study dates
Nov 2015to Dec 2025
Phase
Observational
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Italian patients with metastatic breast cancer

Who may be able to join

  • 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 1 st of January 2000
  • 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

Who cannot join

  • Not consecutive metastatic breast cancer patients grouped for a particular biological type (for example: all HER2 positive patients).

Trial locations and contacts

35 sites in 1 country.

Claudia Bighin, MD contact

0105600898

claudia.bighin@hsanmartino.it

Eva Blondeaux, MD contact

eva.blondeaux@hsanmartino.it

35 sites in 1 country

Italy35 sites, 35 recruiting

  • Centro di Riferimento Oncologico

    Aviano, 33081

    Fabio Puglisi, MD

    Fabio Puglisi, MD

    Recruiting

  • A.O. Consorziale Policlinico di Bari

    Bari, 70124

    Stefania Stucci

    Stefania Stucci

    Recruiting

  • A.O.U. Cagliari

    Cagliari, 09122

    Francesco Atzori

    Francesco Atzori

    Recruiting

  • Fondazione del Piemonte per l'Oncologia - I.R.C.C.

    Candiolo, 10060

    Filippo Montemurro, MD

    Filippo Montemurro, MD

    Recruiting

  • Azienda Ospedaliera Ospedale Sant'Anna

    Como, 22020

    Palma Pugliese, MD

    Palma Pugliese, MD

    Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, 12100

    Paola Vanella, MD

    Paola Vanella, MD

    Recruiting

  • A.O.U. Sant'Anna

    Ferrara, 44124

    Antonio Frassoldati, a.frassoldati@ospfe.it

    Antonio Frassoldati

    Recruiting

  • Ospedale 'F. Spaziani'

    Frosinone, 03100

    Angela Vaccaro, MD

    Angela Vaccaro, MD

    Not yet recruiting

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

    Claudia Bighin, claudia.bighin@hsanmartino.it

    Claudia Bighin

    Recruiting

  • A.O. Ospedale Civile di Legnano

    Legnano, 20025

    Elena Collovà

    Elena Collovà

    Recruiting

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

    Meldola, 47014

    Ugo De Giorgi

    Ugo De Giorgi

    Not yet recruiting

  • ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli

    Milan, 20121

    Gabriella Farina, gabriella.farina@asst-fbf-sacco.it

    Gabriella Farina

    Recruiting

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda

    Milan, 20122

    Ornella Garrone, ornella.garrone@policlinico.mi.it

    Ornella Garrone

    Not yet recruiting

  • A.O.R.N. "A. Cardarelli"

    Naples, 80131

    Ferdinando Riccardi, nando.riccardi@gmail.com

    Ferdinando Riccardi

    Recruiting

  • Azienda ospedaliero universitaria "Federico II"

    Naples, 80131

    Grazia Arpino, MD

    Grazia Arpino, MD

    Recruiting

  • Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'

    Naples, 80131

    Michele De Laurentiis, MD

    Michele De Laurentiis, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

    Antonino Musolino

    Antonino Musolino

    Not yet recruiting

  • Fondazione Maugeri IRCCS

    Pavia, 27100

    Antonio Bernardo, antonio.bernardo@fsm.it

    Antonio Bernardo

    Recruiting

  • A.O.U. Pisana

    Pisa, 56126

    Andrea Fontana, an.fontana@ao-pisa.toscana.it

    Andrea Fontana

    Recruiting

  • IRCCS Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123

    Giancarlo Bisagni, MD

    Giancarlo Bisagni, MD

    Not yet recruiting

  • Istituto Regina Elena per lo studio e la cura dei tumori

    Roma, 00144

    Francesco Cognetti, Md

    Cognetti Francesco, MD

    Recruiting

  • Policlinico Universitario A. Gemelli- DH Radiochemioterapia

    Roma, 00168

    Fabio Marazzi, fabio.marazzi@policlinicogemelli.it

    Fabio Marazzi

    Recruiting

  • Policlinico Universitario Agostino Gemelli, IRCSS-Unità Medicina di Precisione in Senologia

    Roma, 00168

    Alessandra Fabi, alessandra.fabi@policlinicogemelli.it

    Alessandra Fabi

    Recruiting

  • Policlinico Umberto I Università "La Sapienza" di Roma

    Roma, 00185

    Enrico Cortesi

    Enrico Cortesi

    Recruiting

  • Azienda Ospedaliera S. Andrea

    Roma, 00189

    Paolo Marchetti

    Paolo Marchetti

    Not yet recruiting

  • Ospedale Sandro Pertini

    Roma, 00189

    Teresa Gamucci, teresa.gamucci@aslroma2.it

    Teresa Gamucci

    Recruiting

  • Asl Roma 1 - Ospedale Santo Spirito

    Roma, 00193

    Valentina Sini, valentina.sini@aslroma1.it

    Valentina Sini

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Alberto Zambelli, alberto.zambelli@hunimed.eu

    Alberto Zambelli

    Recruiting

  • Azienda Ospedaliera S. Andrea

    Sassari, 07100

    Carlo Putzu

    Carlo Putzu

    Not yet recruiting

  • Ospedale Civile SS. Annunziata

    Sassari, 07100

    Antonio Pazzola

    Antonio Pazzola

    Recruiting

  • Ospedale 'SS. Trinità'

    Sora, 03039

    Angela Vaccaro, MD

    Angela Vaccaro, MD

    Not yet recruiting

  • A.O.U. Città della Salute e della Scienza di Torino - Presidio San Lazzaro

    Torino, 10126

    Alessandra Beano, alessandra.beano@gmail.com

    Alessandra Beano

    Not yet recruiting

  • P.O. Martini - ASL TO1

    Torino, 10141

    Anna Turletti, annaturletti@virgilio.it

    Anna Turletti

    Recruiting

  • ASL Alessandria - Ospedale Civile Santi Antonio e Margherita

    Tortona, 15057

    Marco Galliano

    Marco Galliano

    Recruiting

  • A.O.U. Santa Maria della Misericordia di Udine

    Udine, 33100

    Stefania Russo, MD, stefania.russo@asufc.sanita.fvg.it

    Stefania Russo, MD

    Recruiting

Other trials in Italy

About this study

Official title: Evaluation of Medical Treatments (Chemotherapy, Hormonal Therapy and Biological Therapies) in Metastatic Breast Cancer Patients According to Biologic Subtype and Line of Treatment

Breast cancer is the most common cancer in many countries: in Italy about 48.000 new breast cancers are diagnosed every year and, despite improvements in diagnosis and therapy, about 13.000 women die every year for this disease . About 6-7% of breast cancer patients are metastatic at diagnosis , while the majority of patients with stage IV has a previous history of breast cancer that has already been treated. According to various prognostic factors (tumor size, lymph nodes involvement, grading, hormone receptors status, HER-2 status), in the worst-case scenario, more than 30% of node-negative breast cancer patients and more than 70% of node-positive patients relapse2.

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.

Read more

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) .

Read the detailed description

The primary objectives are to evaluate the duration of metastatic breast cancer treatments (chemotherapy, hormonal therapy and biological therapies) according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative) and to evaluate the number of lines of metastatic breast cancer treatments according to biological subtype (Luminal A, Luminal B, HER2 positive, triple-negative).

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).
Keywords
MBC, metastatic, breast, observational, disease management
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02284581
Study groupRoleWhat they receive
Retrospective cohortAll 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.
Prospective cohortAll 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration and number of lines' treatment

    Measured: Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

Secondary outcomes (4)

  1. Overall Survival according duration

    Measured: Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

  2. Overall survival according number of lines

    Measured: Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

  3. Predictive factors of number of lines

    Measured: Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

  4. Treatment management

    Measured: Retrospectively from 2000 up to site activation; prospectively assested up to 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2014 (estimated)
  2. Study startNov 2015
  3. Primary completionJun 2023
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02284581
Sponsor's protocol ID
GIM14-BIOMETA
Acronym
BIO-META
Status last verified
Nov 2023
First submitted
10 Sep 2014
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20555067

  • 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.

    PubMed 22493340

  • 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.

    PubMed 24453294

  • 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.

    PubMed 21709140

  • 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.

    PubMed 31735691

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by Consorzio Oncotech at 35 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claudia Bighin, MD (0105600898, claudia.bighin@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration and number of lines' treatment (time frame: Retrospectively from 2000 up to site activation; prospectively assested up to 32 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 NCT02284581, which also lists 5 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 13 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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