A study in patients with metastatic breast cancer who have not responded to previous treatment.
- Conditions
- Breast cancerMedDRA version: 18.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005548-27-BE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 132
•Have a diagnosis of HR+, HER2- breast cancer:
- To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor [ER] or progesterone receptor).
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization
•Have the following:
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
- Prior treatment with at least 2 chemotherapy regimens, with at least one administered in the metastatic setting and at least one must have contained a taxane. The additional chemotherapy regimens could have included any of the following: capecitabine, eribulin, gemcitabine, an anthracycline, or vinorelbine.
- No more than 2 prior chemotherapy regimens in the metastatic setting.
• Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy) 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 lease Grade 1) except for residual alopecia and peripheral neuropathy.
• Have adequate organ function, including:
- Hematologic: absolute neutrophil count (ANC) =1.5 × 109/L, platelets =100 × 109/L, hemoglobin =8 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
- Hepatic: bilirubin =1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) =3 × ULN.
- Renal: serum creatinine =ULN.
• Are female and =18 years of age.
• If a woman of child-bearing potential, must test negative for pregnancy at the time of enrollment based on serum pregnancy test, and agree to use a reliable method of birth control during the study and for 3 months following the last dose of the study drug.
• Have the presence of measureable disease as defined by RECIST Version 1.1 (Eisenhauer et al. 2009).
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28
• Have either a history of central nervous system metastasis (CNS) or evidence of CNS metastasis on the MRI of brain obtained at baseline.
• Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. Patients are not eligible if they have received prior therapy with another CDK4/6 inhibitor.
• Have had major surgery within 14 days of the initial dose of study drug.
• 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.
• 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.
• Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
• Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrollment.
• Are lactating women.
• Have initiated approved bisphosphonates or approved RANK ligand targeted agents (for example, denosumab) =28 days prior to Day 1 of Cycle 1.
• Have received recent (within 28 days of initial dose of study drug) or yellow fever vaccination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method