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

Status: Recruiting
Location: See all (35) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Italy
Centro di Riferimento Oncologico
RECRUITING
Aviano
A.O. Consorziale Policlinico di Bari
RECRUITING
Bari
A.O.U. Cagliari
RECRUITING
Cagliari
Fondazione del Piemonte per l'Oncologia - I.R.C.C.
RECRUITING
Candiolo
Azienda Ospedaliera Ospedale Sant'Anna
RECRUITING
Como
Azienda Ospedaliera S. Croce e Carle
RECRUITING
Cuneo
A.O.U. Sant'Anna
RECRUITING
Ferrara
Ospedale 'F. Spaziani'
NOT_YET_RECRUITING
Frosinone
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
A.O. Ospedale Civile di Legnano
RECRUITING
Legnano
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
NOT_YET_RECRUITING
Meldola
ASST Fatebenefratelli Sacco - P.O. Fatebenefratelli
RECRUITING
Milan
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda
NOT_YET_RECRUITING
Milan
A.O.R.N. A. Cardarelli
RECRUITING
Napoli
Azienda ospedaliero universitaria Federico II
RECRUITING
Napoli
Istituto Nazionale per lo studio dei Tumori - Fondazione 'Pascale'
RECRUITING
Napoli
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Fondazione Maugeri IRCCS
RECRUITING
Pavia
A.O.U. Pisana
RECRUITING
Pisa
IRCCS Arcispedale Santa Maria Nuova
NOT_YET_RECRUITING
Reggio Emilia
Asl Roma 1 - Ospedale Santo Spirito
RECRUITING
Roma
Azienda Ospedaliera S. Andrea
NOT_YET_RECRUITING
Roma
Istituto Regina Elena per lo studio e la cura dei tumori
RECRUITING
Roma
Ospedale Sandro Pertini
RECRUITING
Roma
Policlinico Umberto I Università La Sapienza di Roma
RECRUITING
Roma
Policlinico Universitario A. Gemelli- DH Radiochemioterapia
RECRUITING
Roma
Policlinico Universitario Agostino Gemelli, IRCSS-Unità Medicina di Precisione in Senologia
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Ospedaliera S. Andrea
NOT_YET_RECRUITING
Sassari
Ospedale Civile SS. Annunziata
RECRUITING
Sassari
Ospedale 'SS. Trinità'
NOT_YET_RECRUITING
Sora
A.O.U. Città della Salute e della Scienza di Torino - Presidio San Lazzaro
NOT_YET_RECRUITING
Torino
P.O. Martini - ASL TO1
RECRUITING
Torino
ASL Alessandria - Ospedale Civile Santi Antonio e Margherita
RECRUITING
Tortona
A.O.U. Santa Maria della Misericordia di Udine
RECRUITING
Udine
Contact Information
Primary
Claudia Bighin, MD
claudia.bighin@hsanmartino.it
0105600898
Backup
Eva Blondeaux, MD
eva.blondeaux@hsanmartino.it
Time Frame
Start Date: 2015-11
Estimated Completion Date: 2025-12
Participants
Target number of participants: 10000
Treatments
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.
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.
Authors
Maria Giovanna Cavazzini, Marco Carlo Merlano
Related Therapeutic Areas
Sponsors
Leads: Consorzio Oncotech

This content was sourced from clinicaltrials.gov