Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

Placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)

Alpelisib

Alpelisib placebo

Novartis Pharmaceuticals

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1

OS is defined as the time from date of randomization to date of death due to any cause.

ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.

Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.

Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized

Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples. PK parameters includes,but not limited to, Cmin, Cmax, t1/2, AUClast for alpelisib (and any relevant metabolites) and fulvestrant

PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.

Clinical benefit rate is defined as the proportion of patients with a best overall response of CR or PR or SD or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment.

Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.

PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort

Alpelisib qd + Fulvestrant

Placebo qd + Fulvestrant

Total

Age, Continuous

Sex: Female, Male

White

Asian

Unknown

Other

Black or African American

American Indian or Alaska

Race/Ethnicity, Customized

The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant).

Study Director

The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant). Analysis comprised all subjects in the FAS with a PIK3CA mutation who were randomized to study treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.	NCT02437318	Breast Cancer	Fulvestrant Alpelisib Alpelisib place...	18 Years -	Novartis
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.	NCT02437318	Breast Cancer	Fulvestrant Alpelisib Alpelisib place...	18 Years -	Novartis

Spots Global Cancer Trial Database for alpelisib placebo