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A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Metastatic
NCT ID: NCT02057133 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-070

 

The main purpose of this study is to evaluate the safety of a study drug known as LY2835219 in combination with different standard therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, or trastuzumab) for breast cancer that has spread to other parts of the body. The combination of LY2835219 plus trastuzumab was added as a study treatment (by protocol amendment).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Sara Tolaney, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer. - For Part A (LY2835219 + letrozole): Except for ongoing therapy with letrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease. - For Part B (LY2835219 + anastrozole): Except for ongoing therapy with anastrozole, the participant must not have received prior systemic endocrine therapy for metastatic disease. - For Part C (LY2835219 + tamoxifen): The participant may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen. - For Part D (LY2835219 + exemestane): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane. - For Part E (LY2835219 + exemestane + everolimus): The participant must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus. - Have either measureable disease or nonmeasureable but evaluable bone disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) - Participants must have either post-menopausal status or pre-menopausal status if continuing or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist such as goserelin. - Have adequate organ function, including: - Hematologic: Absolute neutrophil count (ANC) ≥1.5 x 10^9/liter (L), platelets ≥ 100 x 10^9/L, and hemoglobin ≥ 8 gram/deciliter (g/dL). - Hepatic: Bilirubin ≤1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 times ULN. - Renal: Serum creatinine ≤ 1.5 times ULN. - Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. - Have discontinued all previous therapies for breast cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy), except for ongoing endocrine therapy, for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug(s), 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. Exclusion Criteria: - Have metastatic breast cancer with severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease. - Have brain metastasis without prior radiotherapy. - Have received prior systemic chemotherapy for metastatic disease. However, the participant may have received prior systemic chemotherapy in the neoadjuvant or adjuvant setting. - Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B (RANK-L) targeted agents (for example, denosumab) ≤28 days prior to Day 1 of Cycle 1. - 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 central nervous system (CNS) metastasis and either radiotherapy or development of neurological changes ≤14 days prior to receiving study treatment. Participants may be receiving a stable dose of corticosteroids. Screening of asymptomatic participants without history of CNS metastasis is not required.
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