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
Public ClinicalTrials.gov record NCT02340221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02340221
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 631 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 9, 2015 (Actual)
- Primary completion
- Jun 29, 2021 (Actual)
- Completion
- Jun 29, 2021 (Actual)
- Last update posted
- Jul 12, 2022
2015 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology | Tucson | Arizona | 85704 | — |
| Arizona Oncology Associates, P.C. | Tucson | Arizona | 85710 | — |
| Georgia Cancer Specialists - Northside | Atlanta | Georgia | 30341 | — |
| Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital | Marietta | Georgia | 30060 | — |
| Ingalls Hospital | Harvey | Illinois | 60426 | — |
| Maryland Oncology Hematology | Rochville | Maryland | 20850 | — |
| Dana Farber Can Ins | Boston | Massachusetts | 02215 | — |
| Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| John Theurer Cancer Ctr at Hackensack Univ Medical Ctr | Hackensack | New Jersey | 07601 | — |
| Memorial Sloan-Kettering; Cancer Center | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology | Beaverton | Oregon | 97006 | — |
| Pinnacle Health | Harrisburg | Pennsylvania | 17110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02340221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 12, 2022 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02340221 live on ClinicalTrials.gov.