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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
Must not have
Participant has received prior treatment with specific inhibitors as listed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization up to maximum duration of 60 months
Awards & highlights

Summary

This trial is testing whether a new drug combination of alpelisib and fulvestrant works better than just fulvestrant alone in men and postmenopausal women with a specific type of advanced breast cancer. Alpelisib targets cancer cell mutations, while fulvestrant blocks hormones that help the cancer grow.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with specific inhibitors before.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria
Secondary study objectives
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%
Dry mouth
10%
Urinary tract infection
10%
Blood creatinine increased
10%
Gamma-glutamyltransferase increased
10%
Aspartate aminotransferase increased
10%
Cough
8%
Nasopharyngitis
8%
Pain in extremity
8%
Dizziness
8%
Hypertension
8%
Anaemia
8%
Constipation
8%
Alanine aminotransferase increased
8%
Hypokalaemia
8%
Dyspnoea
7%
Myalgia
7%
Muscle spasms
7%
Insomnia
6%
Lipase increased
6%
Abdominal pain upper
5%
Lymphoedema
5%
Musculoskeletal pain
5%
Erythema
4%
Upper respiratory tract infection
4%
Bone pain
3%
Hot flush
2%
Osteonecrosis of jaw
2%
Acute kidney injury
1%
Dehydration
1%
Pneumonitis
1%
Pulmonary embolism
1%
Upper gastrointestinal haemorrhage
1%
General physical health deterioration
1%
Cellulitis
1%
Pleural effusion
1%
Hypersensitivity
1%
Pneumonia
1%
Hyponatraemia
1%
Muscular weakness
1%
Brain oedema
1%
Renal failure
1%
Erythema multiforme
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo qd + Fulvestrant
Alpelisib qd + Fulvestrant

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
Fulvestrant
2011
Completed Phase 3
~3890
Alpelisib
2018
Completed Phase 3
~960

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Alpelisib is a PI3K inhibitor that targets the PI3K pathway, which is often mutated in breast cancer, leading to uncontrolled cell growth and survival. By inhibiting this pathway, Alpelisib can reduce tumor growth and proliferation. Fulvestrant is an estrogen receptor antagonist that binds to estrogen receptors on cancer cells, leading to their degradation and preventing estrogen from promoting cancer cell growth. These mechanisms are crucial for breast cancer patients as they directly target the pathways and receptors that drive cancer progression, offering a more tailored and potentially effective treatment approach. Other common treatments include CDK4/6 inhibitors, which block proteins involved in cell division, and aromatase inhibitors, which reduce estrogen production, further hindering cancer cell growth.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Alpelisib for the treatment of <i>PIK3CA</i>-mutated, hormone receptor-positive, HER2-negative metastatic breast cancer.An evidence-based review of the outcome of fulvestrant plus a targeted agent versus fulvestrant alone in treating hormone receptor-positive endocrine therapy-resistant metastatic breast cancer.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,895 Previous Clinical Trials
4,201,230 Total Patients Enrolled
87 Trials studying Breast Cancer
37,521 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
~67 spots leftby Dec 2025