Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)

NCT04227327 | Terminated Phase 2

• 1 other identifier: HERMIONE-7
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 39

Brief Summary

The HERMIONE-7 trial is a phase II, single-arm, open-label, multicenter study in HR+, HER2- advanced breast cancer patients who have received HD-FUL as first-line endocrine treatment for their metastatic disease. Patients will receive aromatase inhibitors plus Abemaciclib.

Conditions

Advanced Breast Cancer

Keywords

abemaciclib; Hormone-Receptor-Positive (HR+); Human-Epidermal-Growth-factor-negative (HER2-)

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole)

  CBR is defined as the proportion of patients in Complete Response (CR), Partial Response (PR) or with Stable Disease (SD) \>= 24 weeks (as defined by RECIST 1.1 Criteria) evaluated at 6 months from treatment initiation.

  At 6 months from treatment initiation

Secondary Outcomes (5)

• Time To Progression (TTP)

  Through study completion, an average of 42 months

• Overall Response Rate (ORR)

  Through study completion, an average of 42 months

• Duration of Overall Response (DoOR)

  Through study completion, an average of 42 months

• Duration of Clinical Benefit (DoCB)

  Through study completion, an average of 42 months

• To assess the safety profile of Abemaciclib in association with aromatase inhibitors (letrozole or anastrozole)

  Through study completion, an average of 42 months

Study Arms (1)

Abemaciclib + aromatase inhibitors

EXPERIMENTAL

Abemaciclib will be administered at 150 mg twice daily orally + Letrozole 2,5 mg daily or Anastrozole 1 mg daily

Drug: Abemaciclib; Drug: Aromatase Inhibitors

Interventions

Abemaciclib DRUG

Abemaciclib will be administered orally at 150 mg twice daily

Abemaciclib + aromatase inhibitors

Aromatase Inhibitors DRUG

Letrozole 2,5 mg daily or Anastrozole 1 mg daily

Abemaciclib + aromatase inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient has a known hypersensitivity to any of the excipients of Abemaciclib or letrozole/anastrozole
• Patient who received any CDK4/6 inhibitor
• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (39)

AOU ospedali riuniti Ancona clinica oncologica

Ancona, Italy

Location

ASL di Asti D.H. - oncologia

Asti, Italy

Location

IRCCS Istituto Oncologico Giovanni Paolo II

Bari, Italy

Location

Ospedale Monsignor Dimiccoli

Barletta, Italy

Location

ULSS 1 Belluno Ospedale San Martino

Belluno, Italy

Location

ASST degli Spedali civili

Brescia, Italy

Location

ASL AL - Ospedale "Santo Spirito"

Casale Monferrato, Italy

Location

ASST Lariana

Como, Italy

Location

ASST Cremona Istituti ospitalieri Cremona

Cremona, Italy

Location

AO S. Croce e Carle Ospedale di Insegnamento

Cuneo, Italy

Location

ASST Monza, Ospedale di Desio

Desio, Italy

Location

ULSS1 Dolomiti - Ospedale di Feltre

Feltre, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Italy

Location

Azienda ospedaliera S. Antonio abate

Gallarate, Italy

Location

AUSL di Reggio Emilia clinica oncologica Guastalla

Guastalla, Italy

Location

Azienda ospedaliera cardinale Giovanni Panico

Lecce, Italy

Location

ASST Lecco

Lecco, Italy

Location

AUSL Toscana Nord Ovest Livorno

Livorno, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

Meldola, Italy

Location

ASST Monza, Ospedale San Gerardo

Monza, Italy

Location

Istituto Oncologico Veneto IRCCS

Padua, Italy

Location

Ospedale La Maddalena

Palermo, Italy

Location

Policlinico universitario di Palermo - oncologia medica

Palermo, Italy

Location

IRCCS Fondazione Salvatore Maugeri

Pavia, Italy

Location

AUSL di Piacenza Ospedale "Guglielmo da Saliceto"

Piacenza, Italy

Location

Arcispedale S. Maria nuova

Reggio Emilia, Italy

Location

ASST Rhodense ospedale di circolo Rho

Rho, Italy

Location

AUSL Romagna ospedale di Rimini

Rimini, Italy

Location

Istituto Nazionale dei tumori Regina Elena- oncologia medica A

Roma, Italy

Location

Istituto Nazionale dei tumori Regina Elena- oncologia medica B

Roma, Italy

Location

Humanitas research hospital

Rozzano, Italy

Location

Ospedale Ruggi d'Aragona

Salerno, Italy

Location

ASST Valle Olona P.O. SARONNO

Saronno, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, Italy

Location

AOU Città della salute e della scienza - Breast Unit

Torino, Italy

Location

ASL Torino presidio ospedaliero Martini

Torino, Italy

Location

APSS provincia autonoma di Trento Ospedale di Trento

Trento, Italy

Location

ASST Settelaghi Varese

Varese, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

Location

MeSH Terms

Interventions

abemaciclib; Aromatase Inhibitors

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: January 13, 2020
• Study Start: January 7, 2020
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (39)