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Advanced Breast CancerPhase 2HERMIONE-7NCT04227327

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

A Phase 2 study testing Abemaciclib and Aromatase Inhibitors in people with Advanced Breast Cancer, run by University of Milano Bicocca at 39 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Abemaciclib and Aromatase Inhibitors
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
39 sitesItaly
Study dates
7 Jan 2020to 25 Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Italy39 sites

  • AOU ospedali riuniti Ancona clinica oncologica

    Ancona

  • ASL di Asti D.H. - oncologia

    Asti

  • IRCCS Istituto Oncologico Giovanni Paolo II

    Bari

  • Ospedale Monsignor Dimiccoli

    Barletta

  • ULSS 1 Belluno Ospedale San Martino

    Belluno

  • ASST degli Spedali civili

    Brescia

  • ASL AL - Ospedale "Santo Spirito"

    Casale Monferrato

  • ASST Lariana

    Como

  • ASST Cremona Istituti ospitalieri Cremona

    Cremona

  • AO S. Croce e Carle Ospedale di Insegnamento

    Cuneo

  • ASST Monza, Ospedale di Desio

    Desio

  • ULSS1 Dolomiti - Ospedale di Feltre

    Feltre

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara

  • Azienda ospedaliera S. Antonio abate

    Gallarate

  • AUSL di Reggio Emilia clinica oncologica Guastalla

    Guastalla

  • Azienda ospedaliera cardinale Giovanni Panico

    Lecce

  • ASST Lecco

    Lecco

  • AUSL Toscana Nord Ovest Livorno

    Livorno

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

    Meldola

  • ASST Monza, Ospedale San Gerardo

    Monza

  • Istituto Oncologico Veneto IRCCS

    Padova

  • Ospedale La Maddalena

    Palermo

  • Policlinico universitario di Palermo - oncologia medica

    Palermo

  • IRCCS Fondazione Salvatore Maugeri

    Pavia

  • AUSL di Piacenza Ospedale "Guglielmo da Saliceto"

    Piacenza

  • Arcispedale S. Maria nuova

    Reggio Emilia

  • ASST Rhodense ospedale di circolo Rho

    Rho

  • AUSL Romagna ospedale di Rimini

    Rimini

  • Istituto Nazionale dei tumori Regina Elena- oncologia medica A

    Roma

  • Istituto Nazionale dei tumori Regina Elena- oncologia medica B

    Roma

  • Humanitas research hospital

    Rozzano

  • Ospedale Ruggi d'Aragona

    Salerno

  • ASST Valle Olona P.O. SARONNO

    Saronno

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

    Torino

  • AOU Città della salute e della scienza - Breast Unit

    Torino

  • ASL Torino presidio ospedaliero Martini

    Torino

  • APSS provincia autonoma di Trento Ospedale di Trento

    Trento

  • ASST Settelaghi Varese

    Varese

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

Other trials in Italy

About this study

Official title: 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

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.

Read the detailed description

Hormone receptor positive tumors represent the most common form of breast cancer and account for most of the deaths from the disease. Endocrine therapy (ET) represents the main initial therapeutic strategy for these patients and has been associated with significant clinical benefits in the majority of them.

Key-Topics for rationale:

  • Fulvestrant, an Estrogen-Receptor (ER) antagonist with no known agonist effects, suppresses estrogen signaling by binding to and degrading the ER. Fulvestrant was approved as a monthly 250 mg dosing regimen based on TTP data demonstrating non-inferiority versus anastrozole in postmenopausal women whose advanced breast cancer had progressed during prior anti-estrogen therapy.
  • The international CONFIRM trial compared Fulvestrant 500 mg (High-Dose Fulvestrant HD-FUL: Fulvestrant 500 mg every month with an additional 500 mg loading dose on Day 14 of the first month) with the monthly 250 mg dose and demonstrated that HD-FUL mg was associated with improved progression-free survival (PFS) and overall survival (OS) in postmenopausal women with ER-positive (ER+) advanced breast cancer whose disease had recurred or progressed after prior endocrine therapy.
  • The FALCON study evaluated the efficacy and safety of HD-FUL in comparison to anastrozole in HR+, HER2- recurrent or metastatic breast cancer (MBC) patients. Median duration of PFS with HD-FUL was 16·6 months (95% CI 13·83-20·99) in the whole population and 22.3 months (95% CI 16·62-32·79) in the non-visceral one. Grade 3 or worse adverse events were reported by 51 (22%) of 228 patients receiving HD-FUL.
  • Palbociclib, Abemaciclib and Ribociclib + Fulvestrant are superior to Fulvestrant alone in terms of PFS (PALOMA-3: 9.5 vs 4.6 months; MONARCH-2: 16.4 vs 9.3; MONALEESA-3: 20.5 vs 12.8) in patients who have received prior endocrine therapy for advanced disease or have relapsed during or within 1 month from adjuvant therapy.
  • A descriptive study analyzed European treatment patterns for HR-positive MBC patients in real-world clinical practice in the years 2004 - 2013 showed that Fulvestrant was the initial therapy for advanced disease in 0.8 - 2.6% of the patients. However, the ongoing real-world GIM-13 AMBRA study showed that in Italy this percentage has grown up to 30%.

At the moment, no data are available regarding the activity of CDK 4/6 inhibitors in patients treated with HD-FUL as 1st-line therapy, nor are there ongoing trials in this setting.

The aim of this study is 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).

This 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.. Abemaciclib will be administered orally at 150 mg twice daily until evidence of disease recurrence or other discontinuation criteria are met, whichever occurs first, together with AIs, as per specific product instructions. The Simon's optimal two-stage design will be used for the conduction of the trial.

Being tested
Abemaciclib, Aromatase Inhibitors
Keywords
abemaciclib, Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Abemaciclib will be administered orally at 150 mg twice daily

  • Aromatase InhibitorsDrug

    Letrozole 2,5 mg daily or Anastrozole 1 mg daily

Study groups in NCT04227327
Study groupRoleWhat they receive
Abemaciclib + aromatase inhibitorsExperimentalAbemaciclib will be administered at 150 mg twice daily orally + Letrozole 2,5 mg daily or Anastrozole 1 mg daily
Receives: Drug: Abemaciclib; Drug: Aromatase Inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 6 months from treatment initiation

Secondary outcomes (5)

  1. Time To Progression (TTP)

    TTP is defined as the time from date of start of treatment to the date of event, i.e. the first documented progression or death due to underlying cancer

    Measured: Through study completion, an average of 42 months

  2. Overall Response Rate (ORR)

    ORR is defined as the proportion of patients with best overall response of CR or PR) according to RECIST 1.1.

    Measured: Through study completion, an average of 42 months

  3. Duration of Overall Response (DoOR)

    DoOR is defined as the time of initial response until documented tumor progression

    Measured: Through study completion, an average of 42 months

  4. Duration of Clinical Benefit (DoCB)

    DoCB is defined as the time of initial CB until documented tumor progression

    Measured: Through study completion, an average of 42 months

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

    The Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 (or higher) will be used when reporting AEs by MedDRA terms. The MedDRA Lower Level Term will be used in the treatment-emergent computation. Treatment-emergent adverse events will be summarized by System Organ Class (SOC) and by decreasing frequency of Preferred Term within SOC.

    Measured: Through study completion, an average of 42 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start7 Jan 2020
  3. Primary completion25 Jul 2024
  4. Study completion25 Jul 2024

Why it stopped: Difficulties in patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227327
Sponsor's protocol ID
HERMIONE-7
Acronym
HERMIONE-7
Status last verified
Jul 2025
First submitted
17 Dec 2019
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Aromatase Inhibitors in people with Advanced Breast Cancer, run by University of Milano Bicocca at 39 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties in patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate (CBR) in HD-FUL pre-treated MBC patients treated with Abemaciclib + aromatase inhibitors (letrozole or anastrozole) (time frame: At 6 months from treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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