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A Phase 2, open label, multicenter, single arm trial evaluating the activity and safety of Abemaciclib + Aromatase Inhibitors (AIs) after 1st-line treatment with High-Dose Fulvestrant in Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-) advanced breast cancer patients The HERMIONE-7 trial


Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Female ≥ 18 years of age regardless of menopausal status, who have relapsed while on prior first-line therapy with HD-FUL
- Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not amenable to curative therapy.
- Patient has a histological and/or cytological confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
- Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
- WHO performance status of 0-2
- Measurable disease (according to Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) or at least one lytic bone lesion
- The patient is able to swallow oral medications.
- The patient has adequate organ function
- Patient has signed ICF (ICF) obtained before any trial-related activities Patients must be able to communicate with the investigator and comply with the requirements of the study procedures.

Criteri di esclusione: 

- Patient has a known hypersensitivity to any of the excipients of Abemaciclib or letrozole/anastrozole
- Patient who received any CDK4/6 inhibitor
- Patient who received > 1 prior systemic hormonal therapy for advanced breast cancer; the only admitted previous therapy as 1st-line treatment is HD FUL. Note: Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
- Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 4.03 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)
- Patient who has received extended-field radiotherapy ≤ 4 weeks or limited field radiotherapy for palliation ≤ 2 weeks prior to start of treatment, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at the investigator's discretion).
- Patients from whom ≥ 25% (Ellis RE 1961) of the bone marrow has been previously irradiated are also excluded.
- Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of treated, basal or squamous cell carcinoma, non melanomatous skin cancer or curatively resected cervical cancer.
- Patient with central nervous system (CNS) metastases unless they meet ALL of the following criteria:
    - At least 4 weeks from prior therapy for CNS disease completion (including radiation and/or surgery) to starting the study treatment
    - Clinically stable CNS lesions at the time of study treatment initiation and not receiving steroids and/or enzyme-inducing anti-epileptic medications for the management of brain metastases for at least 2 weeks
- Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection, or preexisting Crohn's disease or ulcerative colitis, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
- Patient has a known history of HIV infection (testing not mandatory)
- The patient has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, [for example, estimated creatinine clearance <30 mL/min], interstitial lung disease, sever dyspnea at rest or requiring oxygen therapy
- The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: patients with controlled atrial fibrillation for >30 days prior to randomization are eligible. Any patient with a history of VTE (for example, DVT of the leg or arm and/or PE) will be excluded.

Schema di trattamento: 

150 mg twice daily orally + Letrozole 2,5 mg daily, or Anastrozole 1 mg daily

Trattamento sperimentale: 

Abemaciclib + aromatase inhibitors

Trattamento di controllo: 


Obiettivi primari dello studio: 

To describe the activity of Abemaciclib + aromatase inhibitors (AIs - letrozole or anastrozole) in HD-FUL pre-treated MBC patients in terms of Clinical Benefit Rate (CBR).

Obiettivi secondari dello studio: 

To describe:
- Time-To-Progression (TTP)
- Overall Response Rate (ORR)
- Duration of response
- Safety

Centri partecipanti

Nord Italia

Corso Dante 202 - 14100 Asti - AT
D.H Oncologia


ULSS 1 – “San Martino” Belluno
Viale Europa 22 - 32100 Belluno - BL


Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG


Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG


Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS


A.O. S. Anna - U.O di Oncologia Medica
Via Napoleona 60 - 22100 Como - CO
ASST Lariana


Istituti Ospedalieri di Cremona
Viale Trento e Trieste 15 - 26100 Cremona - CR


ASST Rhodense - Osp di Circolo Garbagnate Milanese
Viale Forlanini 95 - 20024 Garbagnate Milanese - MI


ASST Fatebenefratelli Sacco - PO Sacco
Via Giovanni Battista Grassi 74 - 20157 Milano - MI


Corso Europa 250 - 20017 Rho - MI


Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
Sezione di Senologia, Oncologia Medica ed Ematologia


A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Prof.ssa Marina Elena Cazzaniga
Telefono: 0392333539


Ospedale di Piacenza
Via Taverna 49 - 29121 Piacenza - PC


Presidio Ospedaliero di Faenza
Viale Stradone 9 - 48018 Faenza - RA
Ospedale degli Infermi


Azienda USL di Reggio Emilia Ospedale di Guastalla
Via Donatori di Sangue 1 - 42016 Guastalla - RE


AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale S. Maria Nuova

Riferimento: Dr.ssa Gabriella Moretti
Telefono: 0522296696


Ospedale “Infermi” Rimini
Via Settembrini 2 - 47923 Rimini - RN

Riferimento: Prof. Gianni Lorenzo
Telefono: 0541705413


AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
Breast Unit


AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
PO Molinette

Riferimento: Dr. Mario Airoldi
Telefono: 0116334134


Asl TO1
Via Tofane 71 - 10141 Torino - TO
Ospedale Martini



Ospedale S. Anna
Corso Spezia 60 - 10126 Torino - TO
Clinica ostetrico-ginecologica


Presidio ospedaliero di Santa Chiara
Largo Medaglie d'Oro 1 - 38122 Trento - TN


Ospedale di Gallarate, ASST Valle Olona
Via Pastori 4 - 21013 Gallarate - VA
Azienda ospedaliera S. Antonio Abate


ASST Valle Olona - P.O. Saronno
Piazzale Borella 1 - 21047 Saronno - VA

Riferimento: Dr. Claudio Verusio
Telefono: 029613576


Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA
ASST Sette Laghi

Riferimento: Dr.ssa Graziella Pinotti
Telefono: 0332278558


Ospedale di Vicenza
Viale Rodolfi 37 - 36100 Vicenza - VI

Riferimento: Dr.ssa Laura Merlini
Telefono: 0444753906


Centro Italia

Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
Ospedali Riuniti

Riferimento: Prof.ssa Rossana Berardi
Telefono: 0715964169


Ospedale Clinicizzato SS Annunziata
Via Dei Vestini 5 - 66013 Chieti - CH


AOU L'Aquila
Via Saragat, localtà campo di pile - 67100 L'Aquila - AQ
Ospedale San Salvatore - UOC Oncologia Medica


AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI
Oncologia Medica


Ospedale Felice Lotti Pontedera
Via Roma 151 - 56025 Pontedera - PI
U.O. Oncologia

Riferimento: Dr. Giacomo Allegrini
Telefono: 0586223416


Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Oncologia Medica A

Riferimento: Dr.ssa Alessandra Fabi


Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM
Oncologia Medica B


Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA


Ospedale 'Card. G. Panico'
Via San Pio X 4 - 73039 Tricase - LE

Riferimento: Dr. Emiliano Tamburini
Telefono: 0833773111


Ospedale Giovanni Paolo II Olbia
Via Bazzoni - Sircana - 07026 Olbia - OT


AOU Policlinico Paolo Giaccone
Via del Vespro 129 - 90127 Palermo - PA
Oncologia Medica


Casa di Cura La Maddalena
Via San Lorenzo Colli 312/d - 90146 Palermo - PA

Informazioni Generali


Numero di iscrizione a registro: NCT04227327

Data di inserimento: 29.06.2020


Università Milano Bicocca - Scuola di Medicina e Chirurgia



Principal Investigator ITALIA

ASST Monza 

Riferimento: Prof.ssa Marina Elena Cazzaniga

Telefono: 0392333539


Localita: Milano


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