A Study of Nonsteroidal Aromatase Inhibitors Plus LY2835219 or Placebo in Postmenopausal Women With Breast Cancer

Phase 1

• Conditions: Hormone Receptor Positive, HER2 negative Locoregionally Recurrent or Metastatic Breast Cancer with No Prior Systemic Therapy in This Disease Setting; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001502-18-SE
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-10
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• have a diagnosis of HR+, HER2- breast cancer;
• have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease;
• have postmenopausal status due to either surgical/natural menopause or amenorrheic (non-treatment-induced) for at least 12 months;
• have either measurable disease or nonmeasurable bone-only disease;
• have a performance status =1 on the Eastern Cooperative Oncology Group (ECOG) scale;
• have adequate organ function;
• have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy;
• are female and =18 years of age;
• are able to swallow tablets;

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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

• have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
• have inflammatory breast cancer.
• have clinical evidence or a history of CNS metastasis. Screening is not required for enrollment.
• are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer. [Note: A patient may be enrolled if she received prior (neo)adjuvant endocrine therapy (including , but not limited to anti-estrogens or aromatase inhibitors) for localized disease. In addition, a patient may be enrolled if she has received =2 weeks of NSAI in this disease setting immediately preceding screening and agrees to discontinue NSAI until study treatment initiation.]
• have received prior (neo)adjuvant endocrine therapy (e.g., anti-estrogens or aromatase inhibitors) with a disease-free interval =12 months from completion of treatment.
• are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer. [Note: Patients may be enrolled if they received prior (neo)adjuvant chemotherapy for localized disease.]
• have received prior treatment with everolimus
• have received prior treatment with any CDK4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
• have initiated bisphosphonates or approved RANK ligand (RANK-L) targeted agents (for example, denosumab) <7 days prior to randomization
• are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. If a patient is currently enrolled in a clinical trial involving non-approved use of a device, then agreement with the investigator and Lilly clinical research physician (CRP) is required to establish eligibility.
• have received 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.
• have had major surgery within 14 days prior to randomization to allow for post-operative healing of the surgical wound and site(s).
• have received recent (within 28 days prior to randomization) yellow fever vaccination.
• have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis).
• have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.

Study & Design

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