Clinical Trials /

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

NCT02340221

Description:

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

SANDPIPER Study: A Study Of <span class="go-doc-concept go-doc-intervention">Taselisib</span> + <span class="go-doc-concept go-doc-intervention">Fulvestrant</span> Versus <span class="go-doc-concept go-doc-intervention">Placebo</span> + <span class="go-doc-concept go-doc-intervention">Fulvestrant</span> In Patients With Advanced or Metastatic <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Who Have Disease Recurrence or Progression During or After <span class="go-doc-concept go-doc-intervention">Aromatase Inhibitor</span> Therapy

Title

  • Brief Title: SANDPIPER Study: A Study Of Taselisib + Fulvestrant Versus Placebo + Fulvestrant In Patients With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
  • Official Title: A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE AND HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE DISEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY
  • Clinical Trial IDs

    NCT ID: NCT02340221

    ORG ID: GO29058

    NCI ID: 2014-003185-25

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    fulvestrant Faslodex Placebo + Fulvestrant Arm, Taselisib + Fulvestrant Arm
    placebo Placebo + Fulvestrant Arm
    taselisib GDC-0032; RO5537381 Taselisib + Fulvestrant Arm

    Trial Purpose

    This international, multicenter, randomized, double-blinded, placebo-controlled study is
    designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo
    + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal
    growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or
    metastatic breast cancer after recurrence or progression during or after an aromatase
    inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the
    placebo arm. Enrollment will be enriched for patients with PIK3CA mutant tumors via central
    testing. The anticipated duration of the study is approximately 3.5 years.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Placebo + Fulvestrant Arm Experimental fulvestrant, placebo
    Taselisib + Fulvestrant Arm Experimental fulvestrant, taselisib

    Eligibility Criteria

    Inclusion Criteria:

    - Postmenopausal women with histologically or cytologically confirmed locally advanced
    or metastatic estrogen-receptor positive (ER+) breast cancer

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic
    chemotherapy is not indicated at time of entry into the study

    - Radiologic/objective evidence of recurrence or progression to the most recent
    systemic therapy for breast cancer

    - Recurrence or progression during or after aromatase inhibitor

    - Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors
    (RECIST) version 1.1

    - Consent to provide tumor tissue (block or a minimum of 20 slides) from the most
    recent tumor tissue for PIK3CA-mutation testing; a valid cobas PIK3CA mutation
    result by central testing is required

    - Adequate hematologic and end-organ function within 28 days prior to treatment
    initiation

    Exclusion Criteria:

    - HER2-positive disease by local laboratory testing (immunohistochemistry [IHC] 3+
    staining or in situ hybridization positive)

    - Prior treatment with fulvestrant

    - Prior treatment with a PI3K inhibitor, mTOR inhibitor (e.g. everolimus), or AKT
    inhibitor

    - Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1

    - Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1

    - All acute treatment-related toxicity must have resolved to Grade </= 1 or be deemed
    stable by the Investigator

    - Prior treatment with > 1 cytotoxic chemotherapy regimen for metastatic breast cancer

    - Concurrent hormone replacement therapy

    - Known untreated or active central nervous system (CNS) metastases

    - Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications

    - History of inflammatory bowel disease or active bowel inflammation

    - Clinically significant cardiac or pulmonary dysfunction

    - Clinically significant history of liver disease, including cirrhosis, current alcohol
    abuse, or current known active infection with HIV, hepatitis B or C virus

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Progression-free survival (PFS)

    Secondary Outcome Measures

    Overall survival

    Overall objective response rate (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1

    Clinical benefit, defined as objective response (PR+CR), or stable disease (SD) lasting for at least 24 weeks since randomization

    Duration of objective response

    Incidence of adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

    Trial Keywords