A Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Phase 1

• Conditions: Breast cancer; MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000288-18-DE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-23
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

•Have a diagnosis of HR+, HER2- breast cancer
•Relapsed or progressed following endocrine therapy
•Have received prior treatment with at least 2 chemotherapy regimens, of which 1 but no more than 2 have been administered in the metastatic setting
•Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
•Have a performance status =1 on the ECOG scale
•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
•Have adequate organ function
•Have negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment
•Are able to swallow oral medication

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 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

Exclusion Criteria

•Have clinical evidence or history of central nervous system metastasis
•Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
•Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
•Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
•Have active bacterial or fungal infection, or detectable viral infection
•Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor
•Have a preexisting chronic condition resulting in persistent diarrhea
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified