abemaciclib for Metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- Have a diagnosis of HR+, HER2- breast cancer.\n- Relapsed or progressed following endocrine therapy.\n- Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.\n- Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n- Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.\n- Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.\n- Have adequate organ function.\n- Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment.\n- Are able to swallow oral medication."}

Exclusion criteria

• {"criterion_text":"- Have clinical evidence or history of central nervous system metastasis.\n- Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n- Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.\n- Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.\n- Have a preexisting chronic condition resulting in persistent diarrhea.\n- Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years."}

Primary endpoints

• {"endpoint_text":"- Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months) ]","definition_or_measurement_approach":"Measured as time from baseline to objective disease progression or death from any cause, assessed up to 21 months."}

Secondary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Objective Disease Progression (Up to 21 Months) ]","definition_or_measurement_approach":"Measured as the percentage of participants with a complete or partial response from baseline to objective disease progression, assessed up to 21 months."}

Italy

Earliest CTIS Part Ii Submission Date

17-06-2024

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

654

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Rds Inc.

Responsibilities

Sponsor third party listed with sponsorDuties codes 1 and 5; contact email els.vannylen@iqvia.com

Third parties

• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"codes: 1, 5 (as listed in sponsorDuties)","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"codes: 4 (as listed in sponsorDuties)","organisation_type":"Pharmaceutical company"}