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EventsOncology Pipeline
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
Phase 3
MONARCH plus; NCT02763566
Breast Cancer
CDK4 & 6 Inhibitor
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 & 6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone-Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer*
Key Inclusion Criteria
- Hormone-receptor-positive (HR+), HER2-negative breast cancer
- Participants enrolled in both cohort A and cohort B have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Cohort A must exhibit one of the following:
- Relapsed with radiologic evidence of progression >1 year from completion of adjuvant endocrine therapy (ET) and has received no prior ET for locoregionally recurrent or metastatic disease
- Relapsed with radiologic evidence of progression <1 year from completion of or while receiving adjuvant ET (except for letrozole or anastrozole) and has received no prior ET for locoregionally recurrent or metastatic disease
- Presented with de novo metastatic breast cancer and has not received any prior ET
- Cohort B must exhibit one of the following:
- Relapsed with radiologic evidence of progression while receiving neoadjuvant/adjuvant ET, with no subsequent ET received following progression
- Relapsed with radiologic evidence of progression within 1 year from completion of adjuvant ET, with no subsequent ET received following progression
- Relapsed with radiologic evidence of progression >1 year from completion of adjuvant ET and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line ET for metastatic disease. Patients may not have received more than one line of ET or any prior chemotherapy for metastatic disease
- Presented with de novo metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line ET for metastatic disease. Patients may not have received more than one line of ET or any prior chemotherapy for metastatic disease
- Postmenopausal status
- Measurable disease or nonmeasurable bone-only disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Discontinuation of localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture at least 2 weeks prior to randomization 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
- Able to swallow capsules
- Reliable, willing to be available for the duration of the study, and willing to follow study procedures
Key Exclusion Criteria
- Visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Inflammatory breast cancer
- Evidence or history of central nervous system metastasis
- Currently receiving or has previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
- Prior treatment with everolimus or fulvestrant (for cohort B only)
- Prior therapy with a CDK4 & 6 inhibitor
- Initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
- Currently enrolled in a clinical trial involving an investigational product (IP) or nonapproved use of a drug or device (other than the IP/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. If a participant is currently enrolled in a clinical trial involving nonapproved use of a device, then agreement with the investigator and Eli Lilly and Company (Lilly) clinical research physician (CRP) is required to establish eligibility
- Major surgery within 14 days prior to randomization to allow for postoperative healing of the surgical wound and site(s)
- Received recent (within 28 days prior to randomization) live attenuated vaccines such as yellow fever vaccine
- Received an autologous or allogeneic stem cell transplant
- Prior treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
- Serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (eg, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis)
- Syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest within the last 12 months
- History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission with no therapy for a minimum of 3 years
- Active bacterial, fungal, and/or known viral infection
*
This clinical trial is being conducted outside the United States.
†
Abemaciclib or placebo equivalent is administered PO Q12H on days 1-28 of a 28-day cycle.
‡
Anastrozole or letrozole is administered PO Q24H on days 1-28 of a 28-day cycle.
§
Fulvestrant is administered intramuscularly on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
Need additional information or have a question:
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.