Advanced metastatic bre Ast Cancer GIM13-AMBRA Clinical trials should continue to be performed, even after approval of a new treatment, providing real world performance of the therapy. - ABC3 Consensus Guidelines - (Cardoso F, Ann Oncol 2016) Advanced metastatic bre Ast Cancer “Studio Osservazionale Longitudinale di Coorte sulle scelte terapeutiche del carcinoma mammario metastatico HER2-negativo nella pratica clinica Italiana” Marina E Cazzaniga Direttore, Centro di Ricerca di Fase I ASST Monza PI Studio GIM 13 - AMBRA Napoli, 11 marzo 2017

Disegno dello studio M1BC HER2-negativo (+/- HT x M1), candidate a chemioterapia di prima linea (2015-2016 coorte prospettica) o che abbiano ricevuto un trattamento di prima, seconda o successiva linea di chemioterapia per M1 (2014-2013-2012 - coorte retrospettiva) Previsione: 1500 pazienti Arruolamento sequenziale e consecutivo 2012 - 2013 - 2014 2015 - 2016 20 pazienti 10 pazienti follow up – 12 mesi Data ultimo Consenso Informato Coorte retrospettiva Coorte prospettica

on behalf of the GIM13 - AMBRA Study Group First and further line choices of treatment for HER2-ve metastatic breast cancer (MBC) according to adjuvant treatment and biological subtype. Preliminary results of the observational GIM-13 - AMBRA Italian study Mustacchi G, Cazzaniga ME, Biganzoli L, De Laurentiis M, Del Mastro L, De Placido S, Donadio M, Garrone O, Giordano M, , Latini L, Livi L, Marchetti P, Michelotti A, Montemurro F, Natoli C, Pronzato P, Turletti A, Riccardi F on behalf of the GIM13 - AMBRA Study Group

Patients’ characteristics Mean Age at primary: 62 (33-90) Age 40-59, 55.8% Patient ‘s main characteristics Patient ‘s main characteristics Patient ‘s main characteristics Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8%

Tumours’ subtypes How many Luminal A pts received adjuvant CHT?

Adjuvant treatments

1st-line treatments Taxane-based regimens w/o Bevacizumab were the preferred choices in TNBC pts

2nd-line treatment

3rd-line treatment

Median Time to Treatment Change (TTC) in the metastatic setting Which was the duration of 1°-line treatment? How many pts received HT as maintenance therapy?

Taxanes in the metastatic setting

Conclusions Treatment for MBC is strongly related to the type of the adjuvant regimen received Marginal use of anthracyclines, taxanes widely used in any line. In 1st line, the most used regimens are Taxane and Bevacizumab or Capecitabine/Vinorelbine No significant difference have been observed according to biological subtype, except for Platinum-based regimens in TNBC. Endocrine treatment alone remains the preferred choice in 1st and 2nd line in Luminal cases. TTC seems to be a reliable surrogate for PFS in the “real world” practice .

P5-14-09 Luminal A breast cancer: Is it really a good prognosis disease? Prelimary results of the GIM-13 - AMBRA study Cazzaniga ME, Mustacchi G, Giordano M, Donadio M, Garrone O, Del Mastro L, Livi L, Natoli C, Turletti A, Michelotti A, Riccardi F, Montemurro F, Biganzoli L, Latini L, Pronzato P, De Placido S, De Laurentiis M, Marchetti P on behalf of the AMBRA Study Group

Patients’ characteristics 234 Luminal A Out of 747 pts enrolled until May 2016 Median age at primary diagnosis: 50 (42-76) Main histology: Ductal carcinoma 68.3% Patient ‘s main characteristics Patient ‘s main characteristics Patient ‘s main characteristics 747 pts enrolled until May 2016  234 Luminal A Median age at primary: 50 (42-76) Histology: Ductal carcinoma 68.3% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8% Mean Age at primary: 62 (33-90) Age 40-59 55.8%

Adjuvant CHT in Luminal A patients 63.3% of Luminal A patients received adjuvant chemotherapy

Main sites of disease at 1st relapse

Biological subtypes at the re-test Biological markers (especially HR and HER-2) should be reassessed at least once in the metastatic setting, if clinically feasible. (Cardoso F, Ann Oncol 2016) 57.3% of the patients underwent a biopsy at the first relapse

Conclusions Luminal A tumours have a quite long DFI Half of the Luminal A patients have received adjuvant chemotherapy, mainly anthra-based Biopsy at first relapse has been done in 57.3% of the cases Relapse at visceral sites is present in half of the cases

ASCO 2017 Choice of treatment and adherence to International ESO-ESMO (ABC) guide-lines in HR+/HER2-ve metastatic breast cancer (MBC) patients (pts) – Preliminary results of the GIM 13 - AMBRA Study Characteristics of disease activity able to identify risk categories and probability to respond to 1st-line endocrine therapy (ET) in HR+ve/HER2-ve metastatic breast cancer (MBC) patients (pts): dream or reality? Evaluation of a composite risk score in a subgroup population of the GIM 13 – AMBRA Study The role of Taxanes in HR+ve/HER2-ve Metastatic Breast Cancer (MBC) patients (pts) from Adjuvant to Metastatic setting in the clinical practice. Results from GIM13 - AMBRA study

Emendamento N.1 L’Emendamento è previsto per gennaio 2017 e introdurrà le seguenti modifiche al Protocollo: Estensione del periodo di pazienti osservate: dal 2010 al 2017, senza distinzione fra coorte retrospettiva e coorte prospettica Ampliamento casistica fino a 50 pazienti Modifica all’elenco dei centri partecipanti con aggiunta di nuovi centri