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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02437318
Ethics application status
Date submitted
22/04/2015
Date registered
7/05/2015
Date last updated
29/04/2019

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 - Alpelisib placebo

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)


Treatment: Drugs: Fulvestrant


Treatment: Drugs: Alpelisib


Treatment: Drugs: Alpelisib placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) for patients with PIK3CA mutant status - 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
Timepoint [1] 0 0
Up to approximatly 36 months
Secondary outcome [1] 0 0
Overall survival (OS) for patients with PI3KCA mutant status - OS is defined as the time from date of randomization to date of death due to any cause.
Timepoint [1] 0 0
Up to approximatly 59 months
Secondary outcome [2] 0 0
Overall response rate (ORR) - 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.
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 - Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Timepoint [3] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [4] 0 0
Safety and tolerability of alpelisib in combination with fulvestrant - 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.
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 - 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
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 - 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
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 - PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.
Timepoint [7] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [8] 0 0
Clinical benefit rate (CBR) - 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.
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 - 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
Timepoint [9] 0 0
Baseline, Up to approximatly 36 months
Secondary outcome [10] 0 0
Summary statistics of fulvestrant and alpelisib plasma concentrations - Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.
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 - PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort
Timepoint [11] 0 0
Up to approximatly 36 months
Secondary outcome [12] 0 0
OS for patients with PIK3CA non-mutant status - OS is defined as the time from date of randomization to date of death due to any cause.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Wahroonga
Recruitment hospital [3] 0 0
Novartis Investigative Site - Wooloongabba
Recruitment hospital [4] 0 0
Novartis Investigative Site - Elizabeth Vale
Recruitment hospital [5] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 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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Florida
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Illinois
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Indiana
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Viedma
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Szeged
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India
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Israel
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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AN
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Italy
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CT
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FC
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Italy
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MI
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Italy
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PA
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Italy
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PD
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PI
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PZ
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RM
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SV
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TO
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Italy
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VR
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Italy
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Napoli
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Aichi
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Hyogo
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Kanagawa
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Kumamoto
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Osaka
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Saitama
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Tokyo
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Sweden
State/province [192] 0 0
Vasteras
Country [193] 0 0
Taiwan
State/province [193] 0 0
Kaohsiung City
Country [194] 0 0
Taiwan
State/province [194] 0 0
Taipei
Country [195] 0 0
Thailand
State/province [195] 0 0
THA
Country [196] 0 0
Thailand
State/province [196] 0 0
Bangkok
Country [197] 0 0
United Arab Emirates
State/province [197] 0 0
Al Ain Abu Dhabi
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Berkshire
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Devon
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Cardiff
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Leicester
Country [202] 0 0
United Kingdom
State/province [202] 0 0
London
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02437318
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

Summary results
Other publications