A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA -Mutant, Hormone Receptor-Positive, HER2 -Negative Locally Advanced or Metastatic Breast Cancer

Conditions

HR+/HER2-Negative Locally Advanced or Metastatic Breast cancer with PIK3CA mutation

Brief summary

1. Progression-free survival

Detailed description

1. Overall survival, 2. Objective response rate, 3. Best overall response rate, 4. Clinical benefit rate, 5. Duration of response, 6. Time to confirmed deterioration (TTCD) in pain, 7. TTCD in physical function, 8. TTCD in Role Function, 9. TTCD in GHS/HRQoL, 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 11. Change from baseline in targeted vital signs, 12. Change from baseline in targeted clinical laboratory test results, 13. Change from baseline in ECG parameters, 14. Plasma concentration of inavolisib at specified timepoints, 15. Plasma concentration of inavolisib at additional specified timepoints in patients enrolled in China, 16. Plasma concentration of palbociclib at specified timepoints, 17. Plasma concentration of fulvestrant at specified timepoints

Related papers

No related papers found yet.

Interventions

DRUGINAVOLISIB

DRUGPALBOCICLIB

DRUGFaslodex 250 mg solution for injection.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Progression-free survival	—

Secondary

Measure	Time frame
1. Overall survival, 2. Objective response rate, 3. Best overall response rate, 4. Clinical benefit rate, 5. Duration of response, 6. Time to confirmed deterioration (TTCD) in pain, 7. TTCD in physical function, 8. TTCD in Role Function, 9. TTCD in GHS/HRQoL, 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 11. Change from baseline in targeted vital signs, 12. Change from baseline in targeted clinical laboratory test results, 13. Change from baseline in ECG parameters, 14. Plasma concentration of inavolisib at specified timepoints, 15. Plasma concentration of inavolisib at additional specified timepoints in patients enrolled in China, 16. Plasma concentration of palbociclib at specified timepoints, 17. Plasma concentration of fulvestrant at specified timepoints	—

Measure

Time frame

1. Overall survival, 2. Objective response rate, 3. Best overall response rate, 4. Clinical benefit rate, 5. Duration of response, 6. Time to confirmed deterioration (TTCD) in pain, 7. TTCD in physical function, 8. TTCD in Role Function, 9. TTCD in GHS/HRQoL, 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), 11. Change from baseline in targeted vital signs, 12. Change from baseline in targeted clinical laboratory test results, 13. Change from baseline in ECG parameters, 14. Plasma concentration of inavolisib at specified timepoints, 15. Plasma concentration of inavolisib at additional specified timepoints in patients enrolled in China, 16. Plasma concentration of palbociclib at specified timepoints, 17. Plasma concentration of fulvestrant at specified timepoints

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Countries

Belgium, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed