Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Milano Bicocca
Treatments:
Aromatase Inhibitors
Criteria
Inclusion Criteria:

1. Female ≥ 18 years of age regardless of menopausal status, who have relapsed while on
prior first-line therapy with HD-FUL

2. Patients with advanced (loco-regionally recurrent, or metastatic) breast cancer not
amenable to curative therapy.

3. Patient has a histological and/or cytological confirmed diagnosis of estrogen-receptor
positive and/or progesterone receptor positive breast cancer by local laboratory.

4. 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.

5. WHO performance status of 0-2

6. Measurable disease (according to Response Evaluation Criteria in Solid Tumors
[RECIST], version 1.1) or at least one lytic bone lesion

7. The patient is able to swallow oral medications.

8. The patient has adequate organ function

9. 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.

Exclusion Criteria:

1. Patient has a known hypersensitivity to any of the excipients of Abemaciclib or
letrozole/anastrozole

2. Patient who received any CDK4/6 inhibitor

3. 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.

4. 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)

5. 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).

6. Patients from whom ≥ 25% (Ellis RE 1961) of the bone marrow has been previously
irradiated are also excluded.

7. 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.

8. Patient with central nervous system (CNS) metastases unless they meet ALL of the
following criteria:

1. At least 4 weeks from prior therapy for CNS disease completion (including
radiation and/or surgery) to starting the study treatment

2. 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

9. 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)

10. Patient has a known history of HIV infection (testing not mandatory)

11. 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

12. 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.