AzTrials
AzTrials

Breast CancerPhase 3SOLAR-1NCT02437318

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.

A Phase 3 study testing Fulvestrant and Alpelisib in people with Breast Cancer, run by Novartis Pharmaceuticals at 197 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Cancer
What is being tested?
Fulvestrant and Alpelisib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
572 participants
Where
197 sitesin 31 countries
Study dates
23 Jul 2015to 9 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

197 sites in 31 countries.

197 sites in 31 countries

United States34 sites

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Good Samaritan Regional Medical Center

    Corvallis, Oregon, 97330

  • Texas Oncology PA Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • City of Hope National Medical Center

    Duarte, California, 91010 3000

  • El Paso Texas Oncology

    El Paso, Texas, 79902

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Fort Wayne Medical Oncology Hematology Inc

    Fort Wayne, Indiana, 46815

  • Prisma Health Upstate

    Greenville, South Carolina, 29615

  • St Lukes Cancer Institute

    Kansas City, Missouri, 64111

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17604

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Detroit Clinical Research Center

    Owosso, Michigan, 48867

  • Mays Cancer Ctr Uthsa Mdacc

    San Antonio, Texas, 78229

  • Kaiser Permanent Southern Californi

    San Diego, California, 92120

  • UCSF

    San Francisco, California, 94115

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Avera Cancer

    Sioux Falls, South Dakota, 57105

  • Florida Cancer Specialists-North

    St. Petersburg, Florida, 33705

  • St Francis Health Comprehensive Cancer Center

    Topeka, Kansas, 66606-169

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

Other trials in United States

Spain19 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Badajoz, Extremadura, 06080

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08024

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Castellon, Valencia, 12002

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28050

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

France16 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Avignon, 84082

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Le Chesnay, 78150

  • Novartis Investigative Site

    Levallois-Perret, 92309

  • Novartis Investigative Site

    Lyon 08, 69373

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915

  • Novartis Investigative Site

    Montpellier, 34070

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Villejuif, 94800

Other trials in France

Germany14 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Friedrichshafen, 88045

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Leipzig, 04277

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23563

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Recklinghausen, 45657

  • Novartis Investigative Site

    Rostock, 18059

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Velbert, 42551

Other trials in Germany

Italy14 sites

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Chieti, CH, 66100

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Negrar, VR, 37024

  • Novartis Investigative Site

    Padova, PD, 35100

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Pontedera, PI, 56025

  • Novartis Investigative Site

    Rionero in Vulture, PZ, 85028

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Sassari, 07100

  • Novartis Investigative Site

    Savona, SV, 17100

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

Japan14 sites

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-8558

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104 8560

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193

  • Novartis Investigative Site

    Kagoshima, 892-0833

  • Novartis Investigative Site

    Kitaadachi-gun, Saitama, 362-0806

  • Novartis Investigative Site

    Kumamoto, 860-8556

  • Novartis Investigative Site

    Maebashi, Gunma, 371 8511

  • Novartis Investigative Site

    Matsuyama, Ehime, 791-0280

  • Novartis Investigative Site

    Minato Ku, Tokyo, 105-8470

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Osaka, Osaka, 541-8567

  • Novartis Investigative Site

    Sapporo, Hokkaido, 003-0804

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Belgium7 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Libramont, 6800

  • Novartis Investigative Site

    Ottignies, 1340

  • Novartis Investigative Site

    Sint-Niklaas, Oost Vlaanderen, 9100

  • Novartis Investigative Site

    Verviers, 4800

Other trials in Belgium

South Korea6 sites

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Brazil5 sites

  • Novartis Investigative Site

    Lajeado, Rio Grande do Sul, 95900-000

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59075 740

  • Novartis Investigative Site

    São José do Rio Preto, 15090 000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002

  • Novartis Investigative Site

    São Paulo, 01236 030

Other trials in Brazil

Canada5 sites

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Israel5 sites

  • Novartis Investigative Site

    Beersheba, 8457108

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Petah Tikva, 4941492

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Argentina4 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, B1884BBF

  • Novartis Investigative Site

    CABA, Buenos Aires, C1125ABD

  • Novartis Investigative Site

    La Rioja, 5300

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

Other trials in Argentina

Australia4 sites

  • Novartis Investigative Site

    Elizabeth Vale, South Australia, 5112

  • Novartis Investigative Site

    Melbourne, Victoria, 3000

  • Novartis Investigative Site

    Wahroonga, New South Wales, 2076

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102

Other trials in Australia

Bulgaria4 sites

  • Novartis Investigative Site

    Plovdiv, 4004

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9002

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Czechia4 sites

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05

  • Novartis Investigative Site

    Prague, Czech Republic, 140 46

  • Novartis Investigative Site

    Prague, 180 00

  • Novartis Investigative Site

    Zlín, Czech Republic, 762 75

Other trials in Czechia

Hungary4 sites

  • Novartis Investigative Site

    Budapest, Pest County, 1134

  • Novartis Investigative Site

    Budapest, H 1122

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Szekszárd, 7100

Other trials in Hungary

Chile3 sites

  • Novartis Investigative Site

    Santiago, 8420383

  • Novartis Investigative Site

    Temuco, Araucania, 4810469

  • Novartis Investigative Site

    Viña del Mar, 2520612

Other trials in Chile

Greece3 sites

  • Novartis Investigative Site

    Athens, 11528

  • Novartis Investigative Site

    Athens, 18547

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

Other trials in Greece

India3 sites

  • Novartis Investigative Site

    Mumbai, 400 012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

Lebanon3 sites

  • Novartis Investigative Site

    Beirut, 10999

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Peru3 sites

  • Novartis Investigative Site

    Lima, LIMA 27

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    Surquillo, Lima region, 34

Other trials in Peru

Romania3 sites

  • Novartis Investigative Site

    Craiova, Dolj, 200347

  • Novartis Investigative Site

    Floreşti, Cluj, 407280

  • Novartis Investigative Site

    Iași, 700483

Other trials in Romania

Russia3 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

Sweden3 sites

  • Novartis Investigative Site

    Gävle, SE-801 87

  • Novartis Investigative Site

    Örebro, 70185

  • Novartis Investigative Site

    Västerås, 721 89

Other trials in Sweden

United Kingdom3 sites

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    Plymouth, PL6 8DH

Other trials in United Kingdom

Austria2 sites

  • Novartis Investigative Site

    Linz, 4010

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Mexico2 sites

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64320

  • Novartis Investigative Site

    San Luis Potosí City, 78200

Other trials in Mexico

Netherlands2 sites

  • Novartis Investigative Site

    Terneuzen, 4535 PA

  • Novartis Investigative Site

    Venray, CE, 5801

Other trials in Netherlands

Taiwan2 sites

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 11217

Other trials in Taiwan

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Hong Kong1 site

  • Novartis Investigative Site

    Pokfulam

Other trials in Hong Kong

About this study

Official 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

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.

Read the detailed description

This was a randomized, double-blind, placebo-controlled, international multicenter Phase III study that evaluated the efficacy and safety of treatment with alpelisib plus fulvestrant versus placebo plus fulvestrant in men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer which had progressed on or after AI treatment.

Subjects were allocated to either the PIK3CA mutant or PIK3CA non-mutant cohort, based on central testing of hotspot-mutations in tumor tissue. Subjects with unknown results were not eligible. Within each cohort, subjects were randomized in a 1:1 ratio to receive either alpelisib 300 mg orally once daily (q.d.), in combination with fulvestrant 500 mg intramuscular (i.m.) on Days 1 and 15 of Cycle 1 and Day 1 of a 28-day cycle thereafter, or placebo daily in combination with fulvestrant 500 mg following the same treatment regimen.

Subjects were treated until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. All subjects who discontinued study treatment were followed for safety, until 30 days after last study treatment administration, except in the case of death, loss to follow-up, or withdrawal of consent.

Subjects who discontinued study treatment for reasons other than disease progression or withdrawal of consent, were followed until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision (post-treatment efficacy follow-up).

Finally, all subjects were followed for survival after discontinuation of study treatment and tumor evaluations until the subject's death, loss to follow-up, or withdrawal of consent for survival follow-up (post-treatment survival follow-up)

Conditions
Breast Cancer
Being tested
Fulvestrant, Alpelisib, Placebo
Keywords
BYL719, HR+, HER2-negative, advanced breast cancer, alpelisib, fulvestrant, PI3K, Phase III, ER+, PgR+, men, postmenopausal, aromatase inhibitor, neoplasms
Medical subject headings
Breast Neoplasms, Multiple Endocrine Neoplasia Type 1, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    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

  • AlpelisibDrug

    Also called BYL719

    300 mg of alpelisib tablets for oral use administered once daily

  • PlaceboDrug

    300 mg of placebo tablets for oral use administered once daily

Study groups in NCT02437318
Study groupRoleWhat they receive
Fulvestrant + alpelisibExperimentalSubjects 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)
Receives: Drug: Fulvestrant; Drug: Alpelisib
Fulvestrant + placeboPlacebo 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)
Receives: Drug: Fulvestrant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months

Secondary outcomes (11)

  1. Overall Survival (OS) in the PIK3CA Mutant Cohort

    OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.

    The OS distribution was estimated using Kaplan-Meier methodology.

    Measured: Once approximately 178 deaths in the PIK3CA mutant cohort had been observed, up to 55.7 months

  2. PFS Per Investigator Assessment in the PIK3CA Non-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.

    Measured: Up to 56.4 months

  3. OS in the PIK3CA Non-mutant Cohort

    OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.

    The OS distribution was estimated using Kaplan-Meier methodology.

    Measured: Up to 56.4 months

  4. Overall Response Rate (ORR) Per Investigator Assessment

    ORR was defined as the percentage 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.

    CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to 56.4 months

  5. Clinical Benefit Rate (CBR) Per Investigator Assessment

    Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1.

    CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to < 10 mm.

    PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

    Measured: Up to 56.4 months

  6. Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score From Baseline

    ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration of ECOG PS by one score was defined as the time from the date of randomization to the date of the event, defined as experiencing at least one score lower than the baseline. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.

    Measured: From baseline up to 56.4 months

  7. 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)

    The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as at least 10% relative to baseline worsening of the GHS/QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.

    Measured: From baseline up to 55.7 months

  8. Change From Baseline in the GHS/QOL Scale Score of the EORTC QLQ-C30

    The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement.

    For each cohort, this analysis only included assessments up to the time point where there were at least 10 patients on each of the 2 treatment groups.

    Measured: Baseline, every 8 weeks after randomization during the first 18 months and thereafter every 12 weeks, up to 120 weeks.

  9. Trough Plasma Concentration of Alpelisib

    Pre-dose plasma concentrations of alpelisib were assessed. Only participants randomized to the alpelisib + fulvestrant arm were included in this analysis.

    Measured: Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days

  10. Trough Plasma Concentration of Fulvestrant

    Pre-dose plasma concentrations of fulvestrant were assessed.

    Measured: Day 15 of Cycle 1, then Day 1 of Cycles 2, 4, 6 and 8. Cycle = 28 days

  11. PFS Per Investigator Criteria in Subjects With PIK3CA Mutation Status Measured in ctDNA at Baseline

    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.

    Subjects were analyzed according to the PIK3CA mutation status (mutant or non-mutant) as identified using plasma ctDNA.

    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.

    Measured: From baseline up to 56.4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2015 (estimated)
  2. Study start23 Jul 2015
  3. Primary completion12 Jun 2018
  4. Study completion9 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02437318
Sponsor's protocol ID
CBYL719C2301
Other IDs
2015-000340-42, 2015
Acronym
SOLAR-1
Status last verified
Feb 2025
First submitted
22 Apr 2015
Last updated
13 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39177931

  • Rodon 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.

    PubMed 38439079

  • Ciruelos 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.

    PubMed 33780274

  • Andre 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.

    PubMed 33246021

  • Rugo 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.

    PubMed 32416251

  • Andre 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.

    PubMed 31091374

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and Alpelisib in people with Breast Cancer, run by Novartis Pharmaceuticals at 197 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Spain, France, Germany, Italy and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort (time frame: Once approximately 243 PFS events in the PIK3CA mutant cohort had been observed, up to 33.3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02437318, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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