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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
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
EPIK-B3 Trial 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.
EPIK-B3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured or a specific type of bone lesion.
Select...
My breast cancer is advanced or has spread and cannot be cured with surgery or radiation.
Select...
I have had only one treatment for my cancer since it spread.
Select...
I am fully active or can carry out light work.
Select...
I have had only one treatment for my cancer since it spread.
EPIK-B3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once approximately 192 pfs events in study part b2 had been observed, up to 22 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once approximately 192 pfs events in study part b2 had been observed, up to 22 months
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 moreSide effects data
From 2017 Phase 2 trial • 340 Patients • NCT0192316853%
Hyperglycaemia
51%
Diarrhoea
45%
Rash
44%
Nausea
41%
Fatigue
32%
Stomatitis
31%
Decreased appetite
22%
Alopecia
20%
Headache
18%
Dysgeusia
18%
Vomiting
17%
Pruritus
17%
Rash maculo-papular
16%
Asthenia
15%
Dry skin
12%
Urinary tract infection
12%
Hypertension
12%
Weight decreased
12%
Insomnia
11%
Alanine aminotransferase increased
11%
Dry mouth
10%
Muscle spasms
9%
Pyrexia
9%
Blood creatinine increased
9%
Blood glucose increased
8%
Aspartate aminotransferase increased
8%
Dyspepsia
8%
Arthralgia
8%
Anxiety
7%
Vision blurred
7%
Oedema peripheral
7%
Hypokalaemia
7%
Cough
6%
Paraesthesia
6%
Hot flush
5%
Mucosal dryness
5%
Abdominal pain
5%
Chills
5%
Myalgia
5%
Dizziness
4%
Vertigo
4%
Abdominal pain upper
4%
Constipation
4%
Viral upper respiratory tract infection
4%
Gamma-glutamyltransferase increased
4%
Depression
3%
Breast pain
2%
Dehydration
2%
Tachycardia
2%
Dyspnoea
2%
Memory impairment
2%
General physical health deterioration
2%
Pleural effusion
2%
Procedural pain
2%
Blood bilirubin increased
2%
Musculoskeletal pain
2%
Abdominal distension
1%
Hypersensitivity
1%
Cardiac failure
1%
Disease progression
1%
Sepsis
1%
Ejection fraction decreased
1%
Hyponatraemia
1%
Hyperuricaemia
1%
Gastroenteritis
1%
Respiratory tract infection
1%
Accidental overdose
1%
Hypercalcaemia
1%
Ureterolithiasis
1%
Deep vein thrombosis
1%
Back pain
1%
Colitis
1%
Stress cardiomyopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alpelisib + Letrozole
Buparlisib + Letrozole
Placebo + Letrozole
EPIK-B3 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
2,855 Previous Clinical Trials
4,197,213 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ongoing jawbone issues not yet healed.My breast cancer is advanced or has spread and cannot be cured with surgery or radiation.I have had acute pancreatitis in the last year or have chronic pancreatitis.I have been diagnosed with type I diabetes or my type II diabetes is not under control.I have a GI condition that could affect how I absorb medication.I have had only one treatment for my cancer since it spread.My tumor has been tested for PIK3CA mutation and PTEN loss.I am allergic to alpelisib, nab-paclitaxel, or their ingredients.I have a tumor that can be measured or a specific type of bone lesion.My bone marrow and organs are functioning well.I have recovered from side effects of cancer treatment, except for hair loss.I have been treated with drugs targeting PI3K, mTOR, or AKT.I am fully active or can carry out light work.My CNS cancer was found recently or hasn't been treated yet.I have been diagnosed with pneumonitis or interstitial lung disease.You have had serious skin reactions like Steven-Johnson Syndrome, erythema multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinophilia and Systemic Syndrome in the past.I have had only one treatment for my cancer since it spread.
Research Study Groups:
This trial has the following groups:- Group 1: alpelisib + nab-paclitaxel
- Group 2: placebo + nab-paclitaxel
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Breast Cancer Patient Testimony for trial: Trial Name: NCT04251533 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many different locations can patients participate in this study?
"There are 35 sites operating for this study, including Mayo Clinic Arizona in Phoenix, Renown Healthcare Systems in Reno, and Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga in Chattanooga."
Answered by AI
Are there other examples of research done on alpelisib?
"There are hundreds of ongoing studies related to alpelisib, with many in Phase 3. Alpelisib trials can be found at several hundred locations around the world."
Answered by AI
What are the goals that this experiment is looking to achieve?
"The primary goal of this study, which will be measured over the course of approximately 22 months, is to observe the Progression-free Survival (PFS) of patients according to investigator assessment. Once 192 PFS events have been observed in Study Part B2, secondary objectives including Overall response rate (ORR), change from baseline in Quality of Life (QoL), and Time to Response (TTR) will also be monitored."
Answered by AI
How many patients are being observed in this clinical trial?
"To successfully run this trial, 566 patients that meet the inclusion criteria are needed. The sponsor of the trial, Novartis Pharmaceuticals, will be carrying out the study at multiple locations; for example, Mayo Clinic Arizona in Phoenix and Renown Healthcare Systems located in Reno."
Answered by AI
When might alpelisib gain official sanction from the FDA?
"There is both preclinical and clinical evidence for alpelisib's efficacy, so it received a score of 3."
Answered by AI
Are there still open positions available in this clinical trial for test subjects?
"Yes, that is accurate. The public information available on clinicaltrials.gov shows that this trial was posted on 6/8/2020 and updated as recently as 10/21/2022. 566 patients are needed for the study, which is taking place at 35 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Virginia
How old are they?
18 - 65
What site did they apply to?
Florida Cancer Specialists Dept of Oncology (2)
Texas Oncology Texas Oncology - Denton
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Other medication didn’t help.
PatientReceived no prior treatments
How responsive is this trial?
Most responsive sites:
- Texas Oncology Texas Oncology - Denton: < 24 hours
- Florida Cancer Specialists Dept of Oncology (2): < 48 hours
Typically responds via
Email
Phone Call
Average response time
- < 2 Days
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