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.

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02437318
• Date of registration: 22/04/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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. SOLAR-1
• Scientific title: 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
• Date of first enrolment: July 23, 2015
• Target sample size: 572
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02437318
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Peru, Portugal, Romania, Russian Federation, Spain, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- If female, patient is postmenopausal

- Patient has identified PIK3CA status

- Patients may be:

- relapsed with documented evidence of progression while on (neo) adjuvant
endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine
therapy with no treatment for metastatic disease;

- relapsed with documented evidence of progression more than 12 months from
completion of (neo)adjuvant endocrine therapy and then subsequently; progressed
with documented evidence of progression while on or after only one line of
endocrine therapy for metastatic disease;

- newly diagnosed advanced breast cancer, then relapsed with documented evidence of
progression while on or after only one line of endocrine therapy

- Patient has recurrence or progression of disease during or after AI therapy (i.e.

letrozole, anastrozole, exemestane).

- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive breast cancer by local laboratory and has HER2 negative
breast cancer

- Patient has either measurable disease per RECIST 1.1 criteria OR at least one
predominantly lytic bone lesion must be present

- Patient has adequate bone marrow function

Exclusion Criteria:

- Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator's best judgment

- Patient has received prior treatment with chemotherapy (except for neoadjuvant/
adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment
with CDK4/6 inhibitors is allowed)

- Patient with inflammatory breast cancer at screening

- Patients with Child pugh score B or C

- Patients with an established diagnosis of diabetes mellitus type I or not controlled
type II

- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more

- Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy
completion to starting the study treatment and has stable CNS tumor at time of
screening and not receiving steroids and/or enzyme inducing ant-epileptic medications
for brain metastases

- Patient has participated in a prior investigational study within 30 days prior to
enrollment or within 5 half-lives of the investigational product, whichever is longer

- Patient has a history of acute pancreatitis within 1 year of screening or a past
medical history of chronic pancreatitis

- Patient who relapsed with documented evidence of progression more than 12 months from
completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

Other protocol-defined inclusion/esclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Fulvestrant

Drug: Alpelisib

Drug: Alpelisib placebo

Primary Outcome(s)

Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort [Time Frame: Once approximately 243 PFS events in this cohort had been observed, up to 32 months]

Secondary Outcome(s)

Clinical Benefit Rate (CBR) [Time Frame: Up to approximatly 36 months]

OS for Patients With PIK3CA Non-mutant Status [Time Frame: Up to approximatly 59 months]

Overall Response Rate (ORR) [Time Frame: Up to approximatly 36 months]

Plasma Concentration-time Profile of Alpelisib Given in Combinatio With Fulvestrant and Appropriate Pharmacokinetics (PK) Parameters [Time Frame: Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8]

Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status [Time Frame: Baseline, Up to approximatly 36 months]

Overall Survival (OS) for Patients With PI3KCA Mutant Status [Time Frame: Up to approximatly 59 months]

Summary Statistics of Fulvestrant and Alpelisib Plasma Concentrations [Time Frame: Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8]

PFS for Patients With PIK3CA Non-mutant Status [Time Frame: Up to approximatly 36 months]

Safety and Tolerability of Alpelisib in Combination With Fulvestrant [Time Frame: Up to approximatly 37 months]

Time to 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30 [Time Frame: Up to approximatly 36 months]

Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30 [Time Frame: Baseline, Up to approximatly 36 months]

PFS Based on Radiology Assessments and Using RECIST 1.1 Criteria [Time Frame: Baseline, Up to approximatly 36 months]

Secondary ID(s)

2015-000340-42

CBYL719C2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02437318