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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02437318




Registration number
NCT02437318
Ethics application status
Date submitted
22/04/2015
Date registered
7/05/2015

Titles & IDs
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.
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
Secondary ID [1] 0 0
2015-000340-42
Secondary ID [2] 0 0
CBYL719C2301
Universal Trial Number (UTN)
Trial acronym
SOLAR-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Alpelisib
Treatment: Drugs - Placebo

Experimental: Fulvestrant + alpelisib - Subjects treated with 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 comparator: Fulvestrant + placebo - Subjects were treated with 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)


Treatment: Drugs: Fulvestrant
500 mg of fulvestrant administered via intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle

Treatment: Drugs: Alpelisib
300 mg of alpelisib tablets for oral use administered once daily

Treatment: Drugs: Placebo
300 mg of placebo tablets for oral use administered once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
Timepoint [1] 0 0
Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months
Secondary outcome [1] 0 0
Overall Survival (OS) in the PIK3CA Mutant Cohort
Timepoint [1] 0 0
Once approximately 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months
Secondary outcome [2] 0 0
PFS Per Investigator Assessment in the PIK3CA Non-mutant Cohort
Timepoint [2] 0 0
Up to 56.4 months
Secondary outcome [3] 0 0
OS in the PIK3CA Non-mutant Cohort
Timepoint [3] 0 0
Up to 56.4 months
Secondary outcome [4] 0 0
Overall Response Rate (ORR) Per Investigator Assessment
Timepoint [4] 0 0
Up to 56.4 months
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) Per Investigator Assessment
Timepoint [5] 0 0
Up to 56.4 months
Secondary outcome [6] 0 0
Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline
Timepoint [6] 0 0
From baseline up to 56.4 months
Secondary outcome [7] 0 0
Time to 10% Deterioration in the Global Health Status (GHS) /Quality of Life (QOL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
Timepoint [7] 0 0
From baseline up to 55.7 months
Secondary outcome [8] 0 0
Change From Baseline in the GHS/QOL Scale Score of the EORTC QLQ-C30
Timepoint [8] 0 0
Baseline, every 8 weeks after randomization during the first 18 months and thereafter every 12 weeks, up to 120 weeks.
Secondary outcome [9] 0 0
Trough Plasma Concentration of Alpelisib
Timepoint [9] 0 0
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days
Secondary outcome [10] 0 0
Trough Plasma Concentration of Fulvestrant
Timepoint [10] 0 0
Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days
Secondary outcome [11] 0 0
PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline
Timepoint [11] 0 0
From baseline up to 56.4 months

Eligibility
Key inclusion criteria
* If female, the patient was postmenopausal.
* The patient had identified PIK3CA status.
* Patients could 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 with advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy.
* The patient had recurrence or progression of the disease during or after AI therapy (i.e., letrozole, anastrozole, exemestane).
* The patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by a local laboratory and had HER2 negative breast cancer.
* The patient had either measurable disease per RECIST 1.1 criteria or at least one predominantly lytic bone lesion present.
* The patient had adequate bone marrow function.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient had symptomatic visceral disease or any disease burden that made the patient ineligible for endocrine therapy per the investigator's best judgment.
* The patient had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, or AKT inhibitor (pre-treatment with CDK4/6 inhibitors was allowed).
* The patient had inflammatory breast cancer at screening.
* Patients had Child pugh score B or C.
* Patients had an established diagnosis of diabetes mellitus type I or uncontrolled type II.
* The patient had Eastern Cooperative Oncology Group (ECOG) performance status 2 or more.
* The patient had CNS involvement unless he/she was at least 4 weeks from prior therapy completion to starting the study treatment and had a stable CNS tumor at the time of screening and was not receiving steroids and/or enzyme-inducing antiepileptic medications for brain metastases.
* The patient had participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever was longer.
* The patient had a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis.
* The patient relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/06/2023
Sample size
Target
Accrual to date
Final
572
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Wahroonga
Recruitment hospital [2] 0 0
Novartis Investigative Site - Wooloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Elizabeth Vale
Recruitment hospital [4] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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Maryland
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02437318