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

Last updated: November 9, 2023
Sponsor: Consorzio Oncotech
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT02284581
GIM14-BIOMETA
  • Ages > 18
  • All Genders

Study 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 . 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.

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) .

Eligibility Criteria

Inclusion

Inclusion Criteria: Retrospective cohort All consecutive metastatic breast cancers patients treated in theparticipating site with a first-line therapy (chemotherapy or hormonal therapy with orwithout biological therapy) from last contact with patient or death which ever event comesfirst retrospectively back until 1 st of January 2000 Prospective cohort All new consecutive metastatic breast cancers patients will be treatedin the participating site with a first-line therapy (chemotherapy or hormonal therapy withor 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-lineor second-line treatment
  • Written informed consent

Exclusion

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

Study Design

Total Participants: 10000
Study Start date:
November 01, 2015
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Centro di Riferimento Oncologico

    Aviano, 33081
    Italy

    Active - Recruiting

  • A.O. Consorziale Policlinico di Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • A.O.U. Cagliari

    Cagliari, 09122
    Italy

    Active - Recruiting

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

    Candiolo, 10060
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ospedale Sant'Anna

    Como, 22020
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, 12100
    Italy

    Active - Recruiting

  • A.O.U. Sant'Anna

    Ferrara, 44124
    Italy

    Active - Recruiting

  • Ospedale 'F. Spaziani'

    Frosinone, 03100
    Italy

    Site Not Available

  • Ospedale `F. Spaziani`

    Frosinone, 03100
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132
    Italy

    Active - Recruiting

  • A.O. Ospedale Civile di Legnano

    Legnano, 20025
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Carlo Poma

    Mantova, 46100
    Italy

    Site Not Available

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

    Meldola, 47014
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli

    Milano, 20121
    Italy

    Active - Recruiting

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda

    Milano, 20122
    Italy

    Site Not Available

  • A.O.R.N. "A. Cardarelli"

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda ospedaliero universitaria "Federico II"

    Napoli, 80131
    Italy

    Active - Recruiting

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

    Napoli, 80131
    Italy

    Active - Recruiting

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

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126
    Italy

    Site Not Available

  • Fondazione Maugeri IRCCS

    Pavia, 27100
    Italy

    Active - Recruiting

  • A.O.U. Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • IRCCS Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Asl Roma 1 - Ospedale Santo Spirito

    Roma, 00193
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Andrea

    Roma, 00189
    Italy

    Site Not Available

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

    Roma, 00144
    Italy

    Active - Recruiting

  • Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma,
    Italy

    Site Not Available

  • Ospedale Sandro Pertini

    Roma, 00189
    Italy

    Active - Recruiting

  • Policlinico Umberto I Università "La Sapienza" di Roma

    Roma, 00185
    Italy

    Active - Recruiting

  • Policlinico Universitario A. Gemelli- DH Radiochemioterapia

    Roma, 00168
    Italy

    Active - Recruiting

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

    Roma, 00168
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S. Andrea

    Sassari, 07100
    Italy

    Site Not Available

  • Ospedale Civile SS. Annunziata

    Sassari, 07100
    Italy

    Active - Recruiting

  • Ospedale 'SS. Trinità'

    Sora, 03039
    Italy

    Site Not Available

  • Ospedale `SS. Trinità`

    Sora, 03039
    Italy

    Site Not Available

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

    Torino, 10126
    Italy

    Site Not Available

  • P.O. Martini - ASL TO1

    Torino, 10141
    Italy

    Active - Recruiting

  • ASL Alessandria - Ospedale Civile Santi Antonio e Margherita

    Tortona, 15057
    Italy

    Active - Recruiting

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

    Udine, 33100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria ´S. Maria della Misericordia´

    Udine, 33100
    Italy

    Site Not Available

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