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PI3K Inhibitor

Alpelisib + Fulvestrant for Breast Cancer (EPIK-B5 Trial)

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Participant has HER2-negative breast cancer as defined by specific testing criteria

Participant has received ≤2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization up to maximum duration of 60 months

Awards & highlights

EPIK-B5 Trial Summary

This trial looks at whether adding the drug alpelisib to standard hormone therapy can help people with a certain type of breast cancer that has come back or progressed after treatment with other drugs.

Who is the study for?

This trial is for adults over 18 with HR-positive, HER2-negative advanced breast cancer who have progressed after treatment with an AI and a CDK4/6 inhibitor. They must have at least one measurable lesion, a PIK3CA mutation, and if female, be postmenopausal. They can't join if they've had more than two systemic therapies in the metastatic setting or prior treatment with certain inhibitors.Check my eligibility

What is being tested?

The study tests the effectiveness of Alpelisib combined with Fulvestrant versus a placebo plus Fulvestrant in men or postmenopausal women whose advanced breast cancer has worsened despite previous treatments. The goal is to gather more data on this combination's safety and efficacy.See study design

What are the potential side effects?

Alpelisib may cause high blood sugar levels, skin rash, diarrhea, nausea; while Fulvestrant can lead to injection site reactions, fatigue, nausea. Side effects vary by individual.

EPIK-B5 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is not HER2 positive.

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I've had 2 or fewer treatments for my cancer, with only one being chemotherapy.

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I have at least one tumor that can be measured.

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My breast cancer is estrogen and/or progesterone receptor positive.

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My cancer came back or got worse after AI and CDK4/6 inhibitor therapy.

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My tumor has a PIK3CA mutation.

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I am a woman and have gone through menopause.

EPIK-B5 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization up to maximum duration of 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization up to maximum duration of 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization up to maximum duration of 60 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) based on BIRC assessments and using RECIST v1.1 criteria

Secondary outcome measures

Change from baseline in global health status/QoL and symptom scale scores of the EORTC QLQ-C30

Clinical benefit rate (CBR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

Duration of response (DOR) with confirmed response based on BIRC assessments and using RECIST v1.1 criteria

+7 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

EPIK-B5 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Alpelisib plus fulvestrantExperimental Treatment2 Interventions

Alpelisib 300 mg orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15, and on Day 1 on every Cycle thereafter, in a 28 days cycle.

Group II: Alpelisib-matching placebo plus fulvestrantPlacebo Group2 Interventions

Alpelisib-matching placebo orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15 and on Day 1 on every Cycle thereafter, in a 28 days cycle. Participants who have disease progression per RECIST v1.1 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alpelisib

2018

Completed Phase 3

~900

Fulvestrant

2011

Completed Phase 3

~3690

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,010 Total Patients Enrolled

87 Trials studying Breast Cancer

37,584 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05038735 — Phase 3

Breast Cancer Research Study Groups: Alpelisib-matching placebo plus fulvestrant, Alpelisib plus fulvestrant

Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT05038735 — Phase 3

Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038735 — Phase 3

Frequently Asked Questions

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

What are the most similar investigational drugs to Alpelisib?

"As of now, there are a total of 158 Alpelisib trials that are still active. Out of these, 36 are currently in Phase 3. Most of these clinical trials are situated in Shanghai, but there are 6446 locations in total running Alpelisib trials."

Answered by AI

Has Alpelisib met the safety standards set by the FDA?

"Alpelisib has received a safety score of 3 because there is both efficacy and safety data available from Phase 3 clinical trials."

Answered by AI

Are people still able to join this experiment?

"The trial is currently ongoing, with the most recent update having been on October 21st, 2022. The clinical study was originally posted on November 29th, 2021."

Answered by AI

How many patients will be included in this clinical trial?

"That is correct, the online information hosted on clinicaltrials.gov reveals that this study is still enrolling patients. This trial was first advertised on November 29th, 2021 and was updated as recently as October 21st, 2022. The research is hoping to find 234 individuals willing to participate at 1 location."

Answered by AI