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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02340221

Run by

Hoffmann-La Roche

People needed

631

Starts

2015-04-09

Expected to finish

2021-06-29

Last updated by the study team

2022-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participants for whom endocrine therapy (example [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
• Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
• Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1
• Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (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

You may not qualify if…

• Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)
• Prior treatment with fulvestrant
• Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (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 less than or equal to (</=) 1 or be deemed stable by the Investigator
• Prior treatment with greater than (>) 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 human immunodeficiency virus (HIV), hepatitis B or C virus

Where it is running

• Arizona Oncology Associates, P.C. — Tucson, Arizona, United States
• Georgia Cancer Specialists - Northside — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital — Marietta, Georgia, United States
• Ingalls Hospital — Harvey, Illinois, United States
• Maryland Oncology Hematology — Rochville, Maryland, United States
• Dana Farber Can Ins — Boston, Massachusetts, United States
• Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis — St Louis, Missouri, United States
• MSKCC at Basking Ridge — Basking Ridge, New Jersey, United States
• John Theurer Cancer Ctr at Hackensack Univ Medical Ctr — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering; Cancer Center — Commack, New York, United States
• Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology — Beaverton, Oregon, United States
• Pinnacle Health — Harrisburg, Pennsylvania, United States
• Liverpool Hospital; Cancer Therapy Centre — Liverpool, New South Wales, Australia
• Macquarie University Hospital — Macquarie Park, New South Wales, Australia
• Newcastle Mater Misericordiae Hospital; Oncology — Waratah, New South Wales, Australia
• Mater Hospital; Oncology — Brisbane, Queensland, Australia
• Austin Hospital; Medical Oncology — Heidelberg, Victoria, Australia
• Sunshine Hospital; Oncology Research — St Albans, Victoria, Australia
• St John of God Murdoch Hospital; Oncology West — Murdoch, Western Australia, Australia
• Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I — Graz, Austria
• Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie — Innsbruck, Austria
• Arizona Oncology — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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