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
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
2 other identifiers
interventional
572
30 countries
195
Brief Summary
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jul 2015
Typical duration for phase_3 breast-cancer
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 7, 2015
CompletedStudy Start
First participant enrolled
July 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2018
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2023
CompletedFebruary 13, 2025
February 1, 2025
2.9 years
April 22, 2015
June 17, 2019
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort
PFS was defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. If a patient did not have an event, PFS was censored at the date of last adequate tumor assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Progression was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months
Secondary Outcomes (11)
Overall Survival (OS) in the PIK3CA Mutant Cohort
Once approximately 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months
PFS Per Investigator Assessment in the PIK3CA Non-mutant Cohort
Up to 56.4 months
OS in the PIK3CA Non-mutant Cohort
Up to 56.4 months
Overall Response Rate (ORR) Per Investigator Assessment
Up to 56.4 months
Clinical Benefit Rate (CBR) Per Investigator Assessment
Up to 56.4 months
- +6 more secondary outcomes
Other Outcomes (1)
Updated PFS Per Investigator Assessment in the PIK3CA Mutant Cohort (Longer Follow-up)
Up to 55.7 months
Study Arms (2)
Fulvestrant + alpelisib
EXPERIMENTALSubjects 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)
Fulvestrant + placebo
PLACEBO COMPARATORSubjects 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)
Interventions
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
300 mg of alpelisib tablets for oral use administered once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (197)
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
City of Hope National Medical Center
Duarte, California, 91010 3000, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Kaiser Permanent Southern Californi
San Diego, California, 92120, United States
UCSF
San Francisco, California, 94115, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists-North
St. Petersburg, Florida, 33705, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
Fort Wayne Medical Oncology Hematology Inc
Fort Wayne, Indiana, 46815, United States
St Francis Health Comprehensive Cancer Center
Topeka, Kansas, 66606-169, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Detroit Clinical Research Center
Owosso, Michigan, 48867, United States
St Lukes Cancer Institute
Kansas City, Missouri, 64111, United States
St Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
University Hospitals of Cleveland Seidman Cancer Center
Cleveland, Ohio, 44106, United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Prisma Health Upstate
Greenville, South Carolina, 29615, United States
Avera Cancer
Sioux Falls, South Dakota, 57105, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology PA Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
El Paso Texas Oncology
El Paso, Texas, 79902, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, Texas, 78229, United States
Texas Oncology Northeast Texas
Tyler, Texas, 75702, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
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Related Publications (6)
Borrego MR, Lu YS, Reyes-Cosmelli F, Park YH, Yamashita T, Chiu J, Airoldi M, Turner N, Fein L, Ghaznawi F, Singh J, Pantoja K, Schnell C, Akdere M, Chia S. SGLT2 inhibition improves PI3Kalpha inhibitor-induced hyperglycemia: findings from preclinical animal models and from patients in the BYLieve and SOLAR-1 trials. Breast Cancer Res Treat. 2024 Nov;208(1):111-121. doi: 10.1007/s10549-024-07405-8. Epub 2024 Aug 23.
PMID: 39177931DERIVEDRodon J, Demanse D, Rugo HS, Burris HA, Simo R, Farooki A, Wellons MF, Andre F, Hu H, Vuina D, Quadt C, Juric D. A risk analysis of alpelisib-induced hyperglycemia in patients with advanced solid tumors and breast cancer. Breast Cancer Res. 2024 Mar 4;26(1):36. doi: 10.1186/s13058-024-01773-1.
PMID: 38439079DERIVEDCiruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, Andre F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. doi: 10.1200/JCO.20.01139. Epub 2021 Mar 29.
PMID: 33780274DERIVEDAndre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Papai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.
PMID: 33246021DERIVEDRugo HS, Andre F, Yamashita T, Cerda H, Toledano I, Stemmer SM, Jurado JC, Juric D, Mayer I, Ciruelos EM, Iwata H, Conte P, Campone M, Wilke C, Mills D, Lteif A, Miller M, Gaudenzi F, Loibl S. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020 Aug;31(8):1001-1010. doi: 10.1016/j.annonc.2020.05.001. Epub 2020 May 13.
PMID: 32416251DERIVEDAndre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.
PMID: 31091374DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
May 7, 2015
Study Start
July 23, 2015
Primary Completion
June 12, 2018
Study Completion
June 9, 2023
Last Updated
February 13, 2025
Results First Posted
August 13, 2019
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
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