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

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-037-15
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-16
• Study Completion: 2020-08-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Women with histologically or cytologically confirmed invasive, ER+ breast cancer:metastatic or inoperable (not amenable to resection or other local therapy with curative intent) locally advanced breast cancer. • Patients for whom endocrine therapy (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 MBC. The AI (letrozole, anastrozole, or exemestane) does not have to be the most recent treatment before randomization. • Measurable disease via RECIST v1.1 or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1. Bone lesions that have been irradiated are not evaluable. • Able and willing to provide written informed consent and to comply with the study protocol. • Age ≥ 18 years. • ECOG of 0 or 1. • Postmenopausal status. • Consent to provide a formalin-fixed paraffin. • A valid cobas PIK3CA mutation result. • Adequate hematologic and end-organ function. • Fasting glucose ≤ 125 mg/dL (6.94 mmol/L)

Exclusion Criteria

• HER2-positive • Prior treatment with fulvestrant. • Prior treatment with a PI3K, mTOR, or AKT inhibitor. • Prior anti-cancer therapy within 2 weeks prior to Cycle 1 Day 1. • Prior radiation therapy within 2 weeks prior to Cycle 1 Day 1. • All acute treatment-related toxicity must have resolved to Grade ≤ 1 or be deemed stable. • Prior treatment with > 1 cytotoxic chemotherapy regimen for MBC. • Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy. • Concurrent hormone replacement therapy. • Known untreated or active CNS metastases. •History of other malignancy. • Type 1 or Type 2 diabetes mellitus requiring medications. • Clinically significant cardiac or pulmonary dysfunction • Current dyspnea at rest or any requirement for supplemental oxygen therapy to perform activities of daily living. • History of malabsorption syndrome or other condition that would interfere with enteral absorption. • Inability or unwillingness to swallow pills or receive intramuscular injections. • Clinically significant history of liver disease. • History of inflammatory bowel disease. • Active bowel inflammation. • Immunocompromised status. • Pregnancy, lactation, or breastfeeding. • Current severe, uncontrolled systemic disease. • Major surgical procedure within 28 days prior to Cycle 1 Day 1 or anticipation of the need for major surgery during the course of study treatment • Inability to comply with study. • Inability to understand EORTC QLQ-C30, QLQ-BR23, and the EQ-5D questionnaires are available.

Study & Design

• Study Type: Interventional
• Study Design: Not specified