Advanced breast cancer Hormone-Receptor-Positive (HR+), Human-Epidermal-Growth-factor-negative (HER2-) MedDRA version: 20.0 Level: LLT Classification code 10006283 Term: Breast neoplasm malignant female System Organ Class: 100000004864
Conditions
Interventions
Trade Name: verzenios
Product Name: abemaciclib
Product Code: [abemaciclib]
Pharmaceutical Form: Tablet
INN or Proposed INN: abemaciclib
Current Sponsor code: abemaciclib
Concentration unit: mg millig
Sponsors
UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
Eligibility
Sex/Gender
All
Inclusion 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. WHO performance status of 0–2 5. Measurable disease (according to Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) or at least one lytic bone lesion 6. The patient is able to swallow oral medications. 7. The patient has adequate organ function 8. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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 = 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: a. At least 4 weeks from prior therapy for CNS disease completion (including radiation and/or surgery) to starting the study treatment b. 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the activity of Abemaciclib with aromatase inhibitors (letrozole or anastrozole) in high dose fulvesartan (HD-FUL) pre-treated metastatic breast cancer patients in terms of clinical benefit rate (CBR).;Secondary Objective: •To evaluate the efficacy in terms of Time To Progression (TTP) •To evaluate the efficacy in terms of Overall Response Rate (ORR) •To estimate Duration of Overall Response (DoOR) •To evaluate duration of Clinical Benefit (DoCB) •To assess the safety profile of Abemaciclib in association with aromatase inhibitors (letrozole or anastrozole) •To evaluate the activity of Abemaciclib with aromatase inhibitors according to the duration of previous HD-FUL treatment;Primary end point(s): Clinical benefit rate (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.;Timepoint(s) of evaluation of this end point: 6 months from treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to Progression (TTP); Overall response rate (ORR); Duration of Overall Response (DoOR); Duration of Clinical Benefit (DoCB); Safety;Timepoint(s) of evaluation of this end point: Entire study duration; Entire study duration; Entire study duration; Entire study duration; Entire study duration | — |
Countries
Italy
Contacts
Public ContactUOC Centro di Ricerca di Fase 1 - d
ASST Monza
Outcome results
None listed