Clinical Trial VICCBRE1411
A Phase 1b Study of LY2835219 in Combination with Endocrine Therapies for Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
- Protocol No. VICCBRE1411
- Open Date: 05/22/2014
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: The primary objective of this study is to evaluate the safety and tolerability of LY2835219 when administered orally in combination with 1) letrozole or 2) anastrozole or 3) tamoxifen 4) exemestane or 5) exemestane plus everolimus to patients with HR+, HER2 negative mBC.
- Disease Sites: Breast
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Anastrozole; Everolimus (RAD001); Exemestane; LY2835219; Letrozole (Femara); Tamoxifen
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT02057133
- Secondary Protocol No: I3Y-MC-JPBH
This study is being done to see how safe an investigational drug is in combination with standard endocrine therapies and how well it will work to help people with HR+, HER2- metastatic breast cancer that is progressing or spreading to other areas.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
• Have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer for Parts A to E.
• 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 a diagnosis of HER2 positive metastatic breast cancer for Part F.
• For Part F (LY2835219 + trastuzumab):The participant must have received at least 1 chemotherapy regimen for metastatic disease and may be receiving ongoing therapy with trastuzumab. The participant must have an estimated left ventricular ejection fraction within the normal range by either echocardiogram or multigated acquisition (MUGA) scan
• Have either measureable disease or nonmeasureable but evaluable bone disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• For Parts A-E: 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 corresponding combination 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. For Part F: concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.
• 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.
• For Parts A-E: Have received prior systemic chemotherapy for metastatic disease. However, the participant may have received prior systemic chemotherapy in the neoadjuvant or adjuvant setting.
• 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.
• For Part F•Cardiac disease including myocardial infarction within 6 months, unstable angina, or New York Heart Association (NYHA) Grade II or greater functional impairment.