Clinical Trials /

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

NCT02747004

Description:

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Abemaciclib</span> (LY2835219) Plus <span class="go-doc-concept go-doc-intervention">Tamoxifen</span> or <span class="go-doc-concept go-doc-intervention">Abemaciclib</span> Alone in Women With <span class="go-doc-concept go-doc-disease">Metastatic Breast Cancer</span>

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
  • Official Title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02747004

    ORG ID: 16339

    NCI ID: I3Y-MC-JPCG

    Trial Conditions

    Metastatic Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Abemaciclib LY2835219 Abemaciclib + Tamoxifen, Abemaciclib, Abemaciclib + Prophylactic Loperamide
    Tamoxifen Abemaciclib + Tamoxifen
    Prophylactic Loperamide Abemaciclib + Prophylactic Loperamide

    Trial Purpose

    The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus
    tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive
    (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Abemaciclib + Tamoxifen Experimental Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib, Tamoxifen
    Abemaciclib Experimental Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib
    Abemaciclib + Prophylactic Loperamide Experimental Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met. Abemaciclib, Prophylactic Loperamide

    Eligibility Criteria

    Inclusion Criteria:

    - Have a diagnosis of HR+, HER2- breast cancer.

    - Relapsed or progressed following endocrine therapy.

    - Have received prior treatment with at least 2 chemotherapy regimens, of which at
    least 1 but no more than 2 have been administered in the metastatic setting.

    - Have the presence of measureable disease as defined by the Response Evaluation
    Criteria in Solid Tumors (RECIST 1.1).

    - Have a performance status 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

    - Have discontinued previous therapies for cancer (including specifically, aromatase
    inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) 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 least Grade 1) except for residual
    alopecia or peripheral neuropathy.

    - Have adequate organ function.

    - Have negative serum pregnancy test within 7 days prior to randomization and agree to
    use medically approved precautions to prevent pregnancy during the study and for 12
    weeks following last dose of study treatment.

    - Are able to swallow oral medication.

    Exclusion Criteria:

    - Have clinical evidence or history of central nervous system metastasis.

    - Have received treatment with a drug that has not received regulatory approval for any
    indication within 14 or 21 days prior to randomization of study drug for a
    nonmyelosuppressive or myelosuppressive agent, respectively.

    - Have had major surgery within 14 days prior to randomization of study drug to allow
    for post-operative healing of the surgical wound and site(s).

    - Have a personal history of any of the following conditions: presyncope or syncope of
    either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular
    fibrillation, or sudden cardiac arrest.

    - Have active bacterial or fungal infection, or detectable viral infection.

    - Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6
    inhibitor.

    - Have a preexisting chronic condition resulting in persistent diarrhea.

    - Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma
    in-situ of the cervix or breast), unless in complete remission with no therapy for a
    minimum of 3 years.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)

    Duration of Response (DoR)

    Overall Survival (OS)

    Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and its Metabolites

    PK: Mean Steady State Exposure of Tamoxifen and Endoxifen

    Change from Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

    Change from Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

    Trial Keywords