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PI3K Inhibitor

Alpelisib for Breast Cancer (SOLAR-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up once approximately 243 pfs events in this cohort had been observed, up to 32 months

Awards & highlights

SOLAR-1 Trial Summary

This trial will test whether adding the drug alpelisib to fulvestrant helps people with hormone receptor-positive, HER2-negative advanced breast cancer live longer without the disease progressing, compared to fulvestrant and placebo.

Eligible Conditions

Breast Cancer

SOLAR-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ once approximately 243 pfs events in this cohort had been observed, up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~once approximately 243 pfs events in this cohort had been observed, up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and once approximately 243 pfs events in this cohort had been observed, up to 32 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort

Secondary outcome measures

Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30

Clinical Benefit Rate (CBR)

OS for Patients With PIK3CA Non-mutant Status

+9 more

Side effects data

From 2023 Phase 3 trial • 572 Patients • NCT02437318

62%

Hyperglycaemia

57%

Diarrhoea

45%

Nausea

35%

Rash

35%

Decreased appetite

26%

Vomiting

26%

Weight decreased

24%

Fatigue

24%

Stomatitis

20%

Asthenia

20%

Alopecia

18%

Mucosal inflammation

18%

Pruritus

17%

Dysgeusia

17%

Headache

15%

Dry skin

14%

Oedema peripheral

14%

Pyrexia

14%

Back pain

13%

Rash maculo-papular

11%

Dyspepsia

11%

Abdominal pain

11%

Arthralgia

10%

Blood creatinine increased

10%

Urinary tract infection

10%

Gamma-glutamyltransferase increased

10%

Dry mouth

10%

Aspartate aminotransferase increased

10%

Cough

Dizziness

Nasopharyngitis

Pain in extremity

Hypertension

Anaemia

Constipation

Alanine aminotransferase increased

Hypokalaemia

Dyspnoea

Myalgia

Muscle spasms

Insomnia

Lipase increased

Abdominal pain upper

Lymphoedema

Musculoskeletal pain

Erythema

Upper respiratory tract infection

Bone pain

Hot flush

Osteonecrosis of jaw

Acute kidney injury

Pleural effusion

Cellulitis

Upper gastrointestinal haemorrhage

Dehydration

Pneumonitis

Pulmonary embolism

General physical health deterioration

Hypersensitivity

Pneumonia

Hyponatraemia

Muscular weakness

Brain oedema

Renal failure

Erythema multiforme

100%

80%

60%

40%

20%

Study treatment Arm

Placebo qd + Fulvestrant

Alpelisib qd + Fulvestrant

SOLAR-1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: fulvestrant + alpelisibExperimental Treatment2 Interventions

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)

Group II: fulvestrant + placeboPlacebo Group2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Alpelisib

2018

Completed Phase 3

~900

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,171 Total Patients Enrolled

87 Trials studying Breast Cancer

37,240 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When will Alpelisib be available for public use?

"Alpelisib's safety is estimated to be a 3. This is because it has reached Phase 3 in clinical trials, meaning that there is efficacy data as well as multiple rounds of data supporting its safety."

Answered by AI

Is this research looking for more participants?

"Unfortunately, this study is not currently looking for new patients. The trial was initially posted on 7/23/2015 and was last edited on 8/9/2022. However, if you are searching for other studies, there are 2695 trials actively searching for participants with breast cancer and 159 studies for Alpelisib actively recruiting participants."

Answered by AI

How many different medical facilities are conducting this clinical trial?

"The trial is based in 41 US Oncology P A locations, Greenville Health System SC-2 in Greenville, South carolina, North Shore University Health System NorthShore University in Evanston, Illinois and other Tyler, Texas."

Answered by AI

Is Alpelisib a common prescription drug?

"159 different clinical trials for Alpelisib are currently ongoing, with 36 of them in the third phase. Many of these medical studies originate from Shanghai but there are 6517 total locations around the world where research is being conducted."

Answered by AI

What condition is Alpelisib most often used to treat?

"Alpelisib has been effective in treating patients with prior endocrine therapy, breast cancer, and other diseases."

Answered by AI

How many people are being recruited for this clinical trial?

"Presently, this study is not enrolling patients. This trial was initially posted on July 23rd, 2015 and most recently updated on August 9th, 2020. If you are looking for other studies, there are 2695 trials actively recruiting breast cancer patients and 159 Alpelisib trials with open enrolment at the moment."

Answered by AI

Recent research and studies

Annals of OncologyJournal

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

Rugo, H.S., F. André, T. Yamashita, H. Cerda, I. Toledano, S.M. Stemmer, J.C. Jurado, et al.. 2020. “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”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.05.001.

pik3caJournal

Alpelisib for <i>pik3ca</i>-mutated, Hormone Receptor–positive Advanced Breast Cancer

André, Fabrice, Eva Ciruelos, Gabor Rubovszky, Mario Campone, Sibylle Loibl, Hope S. Rugo, Hiroji Iwata, et al.. 2019. “Alpelisib for pik3ca-mutated, Hormone Receptor–positive Advanced Breast Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1813904.

Annals of OncologyJournal

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

André, F., E.M. Ciruelos, D. Juric, S. Loibl, M. Campone, I.A. Mayer, G. Rubovszky, et al.. 2021. “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”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2020.11.011.

pik3caJournal