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Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer

NCT02491983

Description:

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Study to Evaluate the Efficacy and Safety of <span class="go-doc-concept go-doc-intervention">Palbociclib</span> in Combination With <span class="go-doc-concept go-doc-intervention">Fulvestrant</span> or <span class="go-doc-concept go-doc-intervention">Letrozole</span> in Patients With ER+, <span class="go-doc-concept go-doc-biomarker">HER2</span>- Locally Advanced or Metastatic <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer
  • Official Title: A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT02491983

    ORG ID: MedOPP67

    Trial Conditions

    Metastatic Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Palbociclib Arm A, Arm B
    Letrozole Arm A
    Fulvestrant Arm B

    Trial Purpose

    This is an international, randomized, open-label, controlled, multicenter phase II clinical
    trial to investigate and compare the safety and efficacy of palbociclib combined with
    fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast
    cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A Active Comparator Combination of Palbociclib and Letrozole Palbociclib, Letrozole
    Arm B Experimental Combination of Palbociclib and Fulvestrant Palbociclib, Fulvestrant

    Eligibility Criteria

    Inclusion Criteria:

    Women 18 years or older with metastatic or locally advanced disease, not amenable to
    curative therapy

    Confirmed diagnosis of HR+/HER2- breast cancer

    Post-menopausal status

    No prior chemotherapy line in the metastatic setting

    Measurable disease defined by RECIST version 1.1, or non-measurable disease

    Eastern Cooperative Oncology Group (ECOG) PS 0-1

    Adequate organ and marrow function, resolution of all toxic effects of prior therapy or
    surgical procedures

    Exclusion Criteria:

    Confirmed diagnosis of HER2 positive disease

    Patients with rapidly progressive visceral disease or visceral crisis.

    Locally advanced breast cancer candidate for a radical treatment.

    Prior (neo)adjuvant endocrine treatment with DFI 12-months from completion of treatment.

    Major surgery within 4 weeks of start of study drug

    Serious concomitant systemic disorder incompatible with the study

    Known active uncontrolled or symptomatic CNS metastases

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    1-year Progression Free Survival

    Secondary Outcome Measures

    Grade 3/4 adverse events, SAEs, deaths and discontinuations

    Time to progression (TTP)

    Overall survival (OS)

    Clinical Benefit Rate

    Overall Response Rate

    Trial Keywords

    metastatic breast cancer

    Endocrine receptors positive

    HER-2 negative