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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 (SANDPIPER)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02340221
First received: January 13, 2015
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Taselisib Drug: Placebo Drug: Fulvestrant Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1) [ Time Frame: From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years) ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization up to death from any cause (up to approximately 3.5 years) ]
  • Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 [ Time Frame: From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years) ]
  • Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 [ Time Frame: From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years) ]
    Clinical benefit is defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization.

  • Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 [ Time Frame: Time from the first occurence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years) ]
  • PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 [ Time Frame: From randomization until the first occurence of disease progression or death from any cause, whichever occurs earlier (up to approximately 3.5 years) ]
  • Pecentage of Participants With Adverse Events [ Time Frame: From randomization up to approximately 3.5 years ]
  • Maximum Observed Plasma Concentration (Cmax) of Taselisib [ Time Frame: 1 to 4 hours (hrs) post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) ]
  • Minimum Observed Plasma Concentration (Cmin) of Taselisib [ Time Frame: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days) ]
  • European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score [ Time Frame: Day 1 of each 28-day Cycle up to 12 weeks after disease progression (up to approximately 3.5 years) ]
  • Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score [ Time Frame: Day 1 of each 28-day Cycle up to 12 weeks after disease progression (up to approximately 3.5 years) ]

Estimated Enrollment: 600
Actual Study Start Date: April 8, 2015
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Taselisib + Fulvestrant
Participants will receive taselisib 4 milligrams (mg) orally (PO) once daily (QD) beginning at Cycle 1, Day 1 and fulvestrant 500 mg intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle, until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Drug: Taselisib
Taselisib 4 mg will be administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
Other Name: GDC-0032, RO5537381
Drug: Fulvestrant
Fulvestrant 500 mg will be administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Other Name: Faslodex
Placebo Comparator: Placebo + Fulvestrant
Participants will receive placebo matching to taselisib PO QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle, until disease progression, unacceptable toxicity, or study termination by the Sponsor.
Drug: Placebo
Placebo matching to taselisib will be administered as per the schedule specified in the respective arm.
Drug: Fulvestrant
Fulvestrant 500 mg will be administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
Other Name: Faslodex

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic 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 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 RECIST 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 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02340221

Contacts
Contact: Reference Study ID Number: GO29058 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 210 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02340221     History of Changes
Other Study ID Numbers: GO29058
2014-003185-25 ( EudraCT Number )
Study First Received: January 13, 2015
Last Updated: June 14, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Aromatase Inhibitors
Fulvestrant
Estradiol
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogens
Hormones

ClinicalTrials.gov processed this record on June 22, 2017