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Clinical trialNCT01437566CompletedPhase 2Interventional

Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Participants Resistant to Aromatase Inhibitor Therapy

SponsorGenentech, Inc.Enrollment318Breast Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Participants with advanced breast cancer (ABC) or Metastatic Breast Cancer (MBC) who have experienced recurrence or progression of their disease while receiving aromatase inhibitor (AI) therapy or who have relapsed within 6 months after completing adjuvant AI therapy will be enrolled in Part I of this study. Participants with ABC or MBC who have received prior AI therapy and who have PIK3CA-mutant tumors will be enrolled in Part II of this study. Part I of the study will assess the effect of the addition of GDC-0941 to fulvestrant (Arm A) and of GDC-0980 to fulvestrant (Arm B) on progression free survival (PFS) compared with fulvestrant + placebo (Arm C). Part II of the study will examine the safety and tolerability and to estimate the effect of GDC-0941 in combination with fulvestrant (Arm D) on PFS versus fulvestrant + placebo (Arm E) in participants who received prior treatment with an AI and whose tumors contain a PIK3CA mutation.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

130 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Facility name not stated

    Buenos Aires, Argentina

  • Facility name not stated

    Santa Fe, Argentina

Australia
  • Facility name not stated

    Kogarah, New South Wales, Australia

  • Facility name not stated

    Wahroonga, New South Wales, Australia

  • Facility name not stated

    South Brisbane, Queensland, Australia

  • Facility name not stated

    Bedford Park, South Australia, Australia

  • Facility name not stated

    Woodville, South Australia, Australia

  • Facility name not stated

    Frankston, Victoria, Australia

  • Facility name not stated

    Parkville, Victoria, Australia

Belgium
  • Facility name not stated

    Brussels, Belgium

  • Facility name not stated

    Brussels, Belgium

  • Facility name not stated

    Edegem, Belgium

  • Facility name not stated

    Leuven, Belgium

  • Facility name not stated

    Liège, Belgium

Canada
  • Facility name not stated

    Montreal, Quebec, Canada

  • Facility name not stated

    Québec, Quebec, Canada

  • Facility name not stated

    Saskatoon, Saskatchewan, Canada

Chile
  • Facility name not stated

    Santiago, Chile

  • Facility name not stated

    Temuco, Chile

  • Facility name not stated

    Valparaíso, Chile

  • Facility name not stated

    Viña del Mar, Chile

Czechia
  • Facility name not stated

    Brno, Czechia

  • Facility name not stated

    Olomouc, Czechia

  • Facility name not stated

    Prague, Czechia

Denmark
  • Facility name not stated

    Aarhus, Denmark

  • Facility name not stated

    Herlev, Denmark

  • Facility name not stated

    København Ø, Denmark

  • Facility name not stated

    Odense, Denmark

  • Facility name not stated

    Roskilde, Denmark

  • Facility name not stated

    Vejle, Denmark

France
  • Facility name not stated

    Paris, France

Germany
  • Facility name not stated

    Berlin, Germany

  • Facility name not stated

    Düsseldorf, Germany

  • Facility name not stated

    Freiburg im Breisgau, Germany

  • Facility name not stated

    Freiburg im Breisgau, Germany

  • Facility name not stated

    Hamburg, Germany

  • Facility name not stated

    München, Germany

  • Facility name not stated

    München, Germany

  • Facility name not stated

    München, Germany

  • Facility name not stated

    Trier, Germany

90 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fulvestrant →GDC-0941GDC-0941 Matching PlaceboGDC-0980GDC-0980 Matching Placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2011
Primary completion
30 Apr 2016
Completion
30 Apr 2016
Last update posted
2 Nov 2016
Registered enrollment
318
Registry id
NCT01437566

Cross-registrations

EU-CTR / CTIS (EudraCT)2010-023763-17

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.