13 11 20

Information and support

  • Get informed
  • Get support
  • Cut my risk
  • Get involved
  • Research
  • CO41012

    Acronym: 

    CO41012

    ACTRN/NCT /ethics: 

    NCT04060862

    Scientific title: 

    A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

    Summary of trial and patient characteristics

    Cancer Type Breast
    Trial Type Treatment
    Phase Phase I, Phase III Tumour Stream Breast
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2019-11-15
    Molecular Target Anticipated End Date 2026-01-30
    Cancer Type Breast
    Trial Type Treatment
    Phase Phase I, Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Breast
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2019-11-15
    Anticipated End Date 2026-01-30

    Trial Summary

    The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

    Lay Summary

    A Phase Ib/III Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

    Sponsor / Cooperative group

    Hoffman-La Roche

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Dr Kerry Cheong Not Yet Recruiting