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PI3K Inhibitor

Alpelisib + Chemotherapy for Advanced Breast Cancer (EPIK-B3 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
Participant has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: Participants must have measurable disease
Participant has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy), or metastatic (stage IV) TNBC
Must not have
Participant with unresolved osteonecrosis of the jaw
Participant has a history of acute pancreatitis within 1 year prior to screening or past medical history of chronic pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once approximately 192 pfs events in study part b2 had been observed, up to 22 months
Awards & highlights

Summary

This trial is testing a new cancer drug to see if it's safe and effective for treating advanced triple negative breast cancer in patients with either a PIK3CA mutation or PTEN loss.

Who is the study for?
This trial is for adults with advanced triple negative breast cancer (TNBC) who have had no more than one prior therapy for metastatic disease and have a specific gene mutation (PIK3CA) or loss of the PTEN gene. They must be in good physical condition, with well-functioning organs and bone marrow.Check my eligibility
What is being tested?
The study tests if alpelisib combined with nab-paclitaxel is safe and effective for TNBC patients with PIK3CA mutations or PTEN loss. Participants are divided into parts based on their genetic status to receive either this combination or placebo.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, blood sugar levels changes that could affect those with diabetes, gastrointestinal issues affecting drug absorption, severe skin reactions, lung problems like pneumonitis, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured or a specific type of bone lesion.
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My breast cancer is advanced or has spread and cannot be cured with surgery or radiation.
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I have had only one treatment for my cancer since it spread.
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I am fully active or can carry out light work.
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I have had only one treatment for my cancer since it spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have ongoing jawbone issues not yet healed.
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I have had acute pancreatitis in the last year or have chronic pancreatitis.
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I have been diagnosed with type I diabetes or my type II diabetes is not under control.
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I am allergic to alpelisib, nab-paclitaxel, or their ingredients.
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I have been treated with drugs targeting PI3K, mTOR, or AKT.
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My CNS cancer was found recently or hasn't been treated yet.
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I have been diagnosed with pneumonitis or interstitial lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once approximately 192 pfs events in study part b2 had been observed, up to 22 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and once approximately 192 pfs events in study part b2 had been observed, up to 22 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
Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in Study Part B1
Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
Progression-free Survival (PFS) Per Investigator Assessment in Study Part B2
Secondary outcome measures
Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in Study Part B2
Clinical benefit rate (CBR) with confirmed response in Study Part A
Clinical benefit rate (CBR) with confirmed response in Study Part B1
+18 more

Side effects data

From 2017 Phase 2 trial • 340 Patients • NCT01923168
60%
Alanine aminotransferase increased
54%
Aspartate aminotransferase increased
47%
Hyperglycaemia
46%
Nausea
38%
Rash
37%
Fatigue
36%
Diarrhoea
31%
Decreased appetite
27%
Dizziness
22%
Pruritus
22%
Stomatitis
20%
Asthenia
20%
Anxiety
17%
Dry skin
16%
Arthralgia
15%
Hot flush
15%
Depression
14%
Dysgeusia
14%
Dyspepsia
12%
Hypertension
12%
Headache
12%
Weight decreased
11%
Rash maculo-papular
10%
Chills
10%
Cough
10%
Tremor
10%
Insomnia
10%
Breast pain
9%
Abdominal pain upper
9%
Constipation
9%
Urinary tract infection
9%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Blood bilirubin increased
7%
Gamma-glutamyltransferase increased
6%
Abdominal pain
6%
Memory impairment
6%
Tachycardia
6%
Vertigo
6%
Dry mouth
6%
Procedural pain
6%
Muscle spasms
6%
Viral upper respiratory tract infection
5%
Myalgia
5%
Oedema peripheral
5%
Musculoskeletal pain
4%
Hepatotoxicity
4%
Blood glucose increased
4%
Vision blurred
4%
Alopecia
2%
Atrial fibrillation
2%
Mucosal dryness
2%
Colitis
2%
Paraesthesia
1%
Skin necrosis
1%
Angioedema
1%
Sepsis
1%
Pyrexia
1%
Iritis
1%
Malaise
1%
Cardiac disorder
1%
Generalised oedema
1%
General physical health deterioration
1%
Epistaxis
1%
Blood creatinine increased
1%
Hypokalaemia
1%
Post procedural haematoma
1%
Syncope
1%
Hypertransaminasaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Buparlisib + Letrozole
Alpelisib + Letrozole
Placebo + Letrozole

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: alpelisib + nab-paclitaxelExperimental Treatment2 Interventions
Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Single arm Open label in Study Part B1
Group II: placebo + nab-paclitaxelPlacebo Group2 Interventions
Double-blinded, Randomized in a 1:1 ratio in Study Parts A and B2 Not applicable in Study Part B1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-paclitaxel
2008
Completed Phase 4
~1330
alpelisib
2020
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,854 Total Patients Enrolled
88 Trials studying Breast Cancer
37,818 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04251533 — Phase 3
Breast Cancer Research Study Groups: alpelisib + nab-paclitaxel, placebo + nab-paclitaxel
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT04251533 — Phase 3
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04251533 — Phase 3
Breast Cancer Patient Testimony for trial: Trial Name: NCT04251533 — Phase 3
~27 spots leftby Jul 2025
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