A study to compare the study medicine (GDC-0810) to another treatment (fulvestrant) in patients with breast cancer

A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

  • Breast Cancer
Trial Status:

Terminated

This trial runs in
Countries
  • Australia
  • Germany
  • South Korea
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT02569801 2015-000106-19 GO29689

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02569801 , GO29689 , 2015-000106-19 Trial Identifier
      Female Gender
      ≥18 Years Age
      No Healthy Volunteers

      This clinical trial was done to study a new medicine called, “GDC-0810”. Researchers wanted to find out how effective GDC-0810 was for patients with ER+/HER2− breast cancer, in comparison to an approved treatment (fulvestrant). Seventy-one patients took part in this study at 26 study centers in 6 countries.

      Trial Summary

      The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02569801 , GO29689 , 2015-000106-19 Trial Identifier
      Fulvestrant, GDC-0810 Treatments
      Breast Cancer Condition
      Official Title

      A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy

      Eligibility Criteria

      Female Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER- (defined by local guidelines) metastatic or inoperable, locally advance breast cancer
      • Participants for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
      • Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic scans within 28 days of Day 1 of Cycle 1
      • Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer
      Exclusion Criteria
      • HER2-positive disease
      • Prior treatment with fulvestrant
      • Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine therapies for advanced or metastatic disease

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