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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
Experimental: fulvestrant + alpelisib - 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 - 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)
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 this cohort had been observed, up to 32 months
Secondary outcome [1] 0 0
Overall Survival (OS) for Patients With PI3KCA Mutant Status
Timepoint [1] 0 0
Up to approximatly 59 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximatly 36 months
Secondary outcome [3] 0 0
Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [3] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [4] 0 0
Safety and Tolerability of Alpelisib in Combination With Fulvestrant
Timepoint [4] 0 0
Up to approximatly 37 months
Secondary outcome [5] 0 0
Time to 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30
Timepoint [5] 0 0
Up to approximatly 36 months
Secondary outcome [6] 0 0
Plasma Concentration-time Profile of Alpelisib Given in Combinatio With Fulvestrant and Appropriate Pharmacokinetics (PK) Parameters
Timepoint [6] 0 0
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Secondary outcome [7] 0 0
PFS Based on Radiology Assessments and Using RECIST 1.1 Criteria
Timepoint [7] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [8] 0 0
Clinical Benefit Rate (CBR)
Timepoint [8] 0 0
Up to approximatly 36 months
Secondary outcome [9] 0 0
Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30
Timepoint [9] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [10] 0 0
Summary Statistics of Fulvestrant and Alpelisib Plasma Concentrations
Timepoint [10] 0 0
Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8
Secondary outcome [11] 0 0
PFS for Patients With PIK3CA Non-mutant Status
Timepoint [11] 0 0
Up to approximatly 36 months
Secondary outcome [12] 0 0
OS for Patients With PIK3CA Non-mutant Status
Timepoint [12] 0 0
Up to approximatly 59 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
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United States of America
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Arizona
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Arkansas
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Maryland
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Tennessee
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Texas
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Virginia
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Washington
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La Roche sur Yon cedex 9
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Nyiregyhaza
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Mumbai
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AN
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FC
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PI
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PZ
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RM
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SS
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SV
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TO
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Kumamoto
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Gyeonggi Do
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Peru
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Lima
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Iasi
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Russian Federation
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Arkhangelsk
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Russian Federation
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Ryazan
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Russian Federation
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St Petersburg
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Andalucia
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Cadiz
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Cataluna
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Catalunya
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Spain
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Comunidad Valenciana
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Extremadura
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Spain
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Galicia
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Santa Cruz De Tenerife
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Sweden
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Gavle
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Sweden
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Oerebro
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Sweden
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Vasteras
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Taiwan
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Taipei
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Thailand
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THA
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Thailand
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Bangkok
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United Kingdom
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Devon
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United Kingdom
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Leicester
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United Kingdom
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London

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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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