Abemaciclib Combination Therapy for Advanced Breast Cancer
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Eli Lilly and Company
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing the safety of abemaciclib when used with other treatments for patients whose breast cancer has spread. Abemaciclib helps to stop cancer cells from growing by blocking certain proteins they need. The study aims to find out if this combination is safe for patients with advanced breast cancer.
Research Team
C1
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for adults with breast cancer that has spread, who have specific treatment histories and organ function. Participants must not have severe preexisting conditions or certain heart diseases, and should not have received some treatments like CDK4/6 inhibitors (except in Part I) or systemic chemotherapy for metastatic disease.Inclusion Criteria
I have been treated with a nonsteroidal aromatase inhibitor for my metastatic disease and may currently be on exemestane.
My cancer progressed despite treatment with CDK4/6 inhibitors and hormone therapy.
My breast cancer is HER2 positive and has spread to other parts.
See 15 more
Exclusion Criteria
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (including interstitial lung disease (ILD), severe dyspnea at rest or requiring oxygen therapy or, history of major surgical resection involving the stomach or small bowel)
I have brain metastases treated with radiotherapy or had neurological changes within the last 14 days.
Your recent heart test showed certain abnormal results like irregular heartbeats, signs of heart problems, or a prolonged QT interval.
See 6 more
Treatment Details
Interventions
- Abemaciclib (CDK4/6 Inhibitor)
- Anastrozole (Aromatase Inhibitor)
- Endocrine therapy (Estrogen Receptor Antagonist)
- Everolimus (mTOR Inhibitor)
- Exemestane (Aromatase Inhibitor)
- Fulvestrant (Estrogen Receptor Antagonist)
- Letrozole (Aromatase Inhibitor)
- Loperamide (Anti-diarrheal Agent)
- Pertuzumab (Monoclonal Antibodies)
- Tamoxifen (Selective Estrogen Receptor Modulator)
- Trastuzumab (Monoclonal Antibodies)
Trial OverviewThe study tests the safety of abemaciclib combined with various therapies (like letrozole, anastrozole, tamoxifen) for advanced breast cancer. It examines how well these combinations work when the cancer has spread to other body parts.
Participant Groups
13Treatment groups
Experimental Treatment
Group I: LY3023414 + LY2835219 + Fulvestrant Dose ExpansionExperimental Treatment3 Interventions
LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered IM.
Group II: LY3023414 + LY2835219 + Fulvestrant Dose EscalationExperimental Treatment3 Interventions
LY3023414 administered orally. LY2835219 administered orally. Fulvestrant administered intramuscularly (IM).
Group III: LY2835219+ Trastuzumab Dose ExpansionExperimental Treatment2 Interventions
LY2835219 administered orally. Trastuzumab administered IV infusion. This arm is closed to enrollment.
Group IV: LY2835219+ Trastuzumab Dose EscalationExperimental Treatment2 Interventions
LY2835219 administered orally. Trastuzumab administered intravenously (IV) infusion. This arm is closed to enrollment.
Group V: LY2835219 +Trastuzumab +Pertuzumab +Loperamide Dose EscalationExperimental Treatment4 Interventions
LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.
Group VI: LY2835219 +Trastuzumab + Pertuzumab +Loperamide Dose ExpansionExperimental Treatment5 Interventions
Hormone Receptor Negative (HR-): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion.
Hormone Receptor Positive (HR+): LY2835219 administered orally. Loperamide administered orally. Trastuzumab administered IV infusion. Pertuzumab administered IV infusion. Endocrine therapy administered orally.
Group VII: LY2835219 + TamoxifenExperimental Treatment2 Interventions
LY2835219 administered orally. Tamoxifen administered orally. This arm is closed to enrollment.
Group VIII: LY2835219 + LetrozoleExperimental Treatment2 Interventions
LY2835219 administered orally. Letrozole administered orally. This arm is closed to enrollment.
Group IX: LY2835219 + Exemestane + Everolimus Dose ExpansionExperimental Treatment3 Interventions
LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment.
Group X: LY2835219 + Exemestane + Everolimus Dose EscalationExperimental Treatment3 Interventions
LY2835219 administered orally. Exemestane administered orally. Everolimus administered orally. This arm is closed to enrollment.
Group XI: LY2835219 + ExemestaneExperimental Treatment2 Interventions
LY2835219 administered orally. Exemestane administered orally. This arm is closed to enrollment.
Group XII: LY2835219 + Endocrine TherapyExperimental Treatment2 Interventions
LY2835219 administered orally. Ongoing endocrine therapy administered orally.
Group XIII: LY2835219 + AnastrozoleExperimental Treatment2 Interventions
LY2835219 administered orally. Anastrozole administered orally. This arm is closed to enrollment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University