Advanced Breast Cancer Clinical Trial
— HERMIONE-7Official 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
Verified date | April 2023 |
Source | University of Milano Bicocca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU ospedali riuniti Ancona clinica oncologica | Ancona | |
Italy | ASL di Asti D.H. - oncologia | Asti | |
Italy | IRCCS Istituto Oncologico Giovanni Paolo II | Bari | |
Italy | Ospedale Monsignor Dimiccoli | Barletta | |
Italy | ULSS 1 Belluno Ospedale San Martino | Belluno | |
Italy | ASST degli Spedali civili | Brescia | |
Italy | ASL AL - Ospedale "Santo Spirito" | Casale Monferrato | |
Italy | ASST Lariana | Como | |
Italy | ASST Cremona Istituti ospitalieri Cremona | Cremona | |
Italy | AO S. Croce e Carle Ospedale di Insegnamento | Cuneo | |
Italy | ASST Monza, Ospedale di Desio | Desio | |
Italy | ULSS1 Dolomiti - Ospedale di Feltre | Feltre | |
Italy | Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | |
Italy | Azienda ospedaliera S. Antonio abate | Gallarate | |
Italy | AUSL di Reggio Emilia clinica oncologica Guastalla | Guastalla | |
Italy | Azienda ospedaliera cardinale Giovanni Panico | Lecce | |
Italy | ASST Lecco | Lecco | |
Italy | AUSL Toscana Nord Ovest Livorno | Livorno | |
Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS | Meldola | |
Italy | ASST Monza, Ospedale San Gerardo | Monza | |
Italy | Istituto Oncologico Veneto IRCCS | Padova | |
Italy | Ospedale La Maddalena | Palermo | |
Italy | Policlinico universitario di Palermo - oncologia medica | Palermo | |
Italy | IRCCS Fondazione Salvatore Maugeri | Pavia | |
Italy | AUSL di Piacenza Ospedale "Guglielmo da Saliceto" | Piacenza | |
Italy | Arcispedale S. Maria nuova | Reggio Emilia | |
Italy | ASST Rhodense ospedale di circolo Rho | Rho | |
Italy | AUSL Romagna ospedale di Rimini | Rimini | |
Italy | Istituto Nazionale dei tumori Regina Elena- oncologia medica A | Roma | |
Italy | Istituto Nazionale dei tumori Regina Elena- oncologia medica B | Roma | |
Italy | Humanitas research hospital | Rozzano | |
Italy | Ospedale Ruggi d'Aragona | Salerno | |
Italy | ASST Valle Olona P.O. SARONNO | Saronno | |
Italy | A.O.U. Città della Salute e della Scienza di Torino | Torino | |
Italy | AOU Città della salute e della scienza - Breast Unit | Torino | |
Italy | ASL Torino presidio ospedaliero Martini | Torino | |
Italy | APSS provincia autonoma di Trento Ospedale di Trento | Trento | |
Italy | ASST Settelaghi Varese | Varese | |
Italy | Azienda Ospedaliera Universitaria Integrata Verona | Verona |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Through study completion, an average of 42 months | |
Secondary | 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. | Through study completion, an average of 42 months | |
Secondary | Duration of Overall Response (DoOR) | DoOR is defined as the time of initial response until documented tumor progression | Through study completion, an average of 42 months | |
Secondary | Duration of Clinical Benefit (DoCB) | DoCB is defined as the time of initial CB until documented tumor progression | Through study completion, an average of 42 months | |
Secondary | 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. | Through study completion, an average of 42 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04653740 -
Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer
|
N/A | |
Completed |
NCT02091960 -
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05156619 -
Health Care Disparities in Culturally Diverse, Special Needs & Disadvantaged Populations - Bridging the Gap
|
||
Recruiting |
NCT05173103 -
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Completed |
NCT00754325 -
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
|
Phase 2 | |
Recruiting |
NCT04953377 -
PFMT Educational Intervention for Patients With Advancer Breast Cancer
|
N/A | |
Completed |
NCT03240224 -
Bioinformation Therapy for Breast Cancer
|
Phase 2/Phase 3 | |
Recruiting |
NCT06193525 -
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test
|
Phase 2 | |
Completed |
NCT03312738 -
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
|
Phase 2 | |
Active, not recruiting |
NCT05063786 -
Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)
|
Phase 3 | |
Recruiting |
NCT05655598 -
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
|
Phase 1 | |
Active, not recruiting |
NCT02499146 -
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT00445458 -
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04456855 -
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
|
||
Completed |
NCT04408118 -
First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC
|
Phase 2 | |
Recruiting |
NCT04222413 -
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
|
Phase 1 | |
Completed |
NCT03205761 -
Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT04316169 -
Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT00546104 -
Phase II Dasatinib Study in Advanced Breast Cancer
|
Phase 2 |