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Alpelisib + Trastuzumab + Pertuzumab for Breast Cancer (EPIK-B2 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 histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic)
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 70 months
Awards & highlights
EPIK-B2 Trial Summary
This trial is testing whether a new drug is effective and safe for people with a certain type of breast cancer.
Who is the study for?
This trial is for HER2-positive advanced breast cancer patients with a PIK3CA mutation who completed up to 8 cycles of taxane-based therapy. They must have good performance status and organ function, no inflammatory breast cancer, uncontrolled heart issues, history of severe skin reactions or lung disease, diabetes type I or uncontrolled type II.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Alpelisib in combination with Trastuzumab and Pertuzumab as maintenance therapy post-taxane induction. It's a two-part study: an initial phase to confirm safe dosage followed by a randomized comparison with placebo.See study design
What are the potential side effects?
Alpelisib may cause high blood sugar levels, rash, diarrhea, nausea; Trastuzumab can lead to heart problems or allergic reactions; Pertuzumab might cause diarrhea, hair loss or fatigue. Side effects vary among individuals.
EPIK-B2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is HER2-positive and cannot be removed by surgery or has spread.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
EPIK-B2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 70 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 70 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Incidence of dose limiting toxicities (DLTs) for each dose level
Part 2: Progression Free Survival (PFS)
Secondary outcome measures
Part 1: Alpelisib concentrations by timepoint and dose level
Part 2: Change in Functional Assessment of Cancer Therapy - Breast (FACT-B) treatment outcomes index (TOI) from baseline
Part 2: Clinical Benefit Rate (CBR) with confirmed response
+8 moreSide effects data
From 2023 Phase 3 trial • 572 Patients • NCT0243731862%
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
8%
Dizziness
8%
Nasopharyngitis
8%
Pain in extremity
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%
Pleural effusion
1%
Cellulitis
1%
Upper gastrointestinal haemorrhage
1%
Dehydration
1%
Pneumonitis
1%
Pulmonary embolism
1%
General physical health deterioration
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
EPIK-B2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Alpelisib + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
Trastuzumab (6mg/kg) + pertuzumab (420 mg) in combination with 200mg alpelisib, with potential for intra-participant dose escalation to 250 mg
Group II: Part 1: Alpelisib + Trastuzumab + PertuzumabExperimental Treatment3 Interventions
In the Part 1, up to 3 alpelisib dose levels may be sequentially tested in 3 cohorts of subjects:
Cohort A: Alpelisib 300mg + trastuzumab (6mg/kg) + pertuzumab (420 mg) Cohort B: Alpelisib 250 mg+ trastuzumab (6mg/kg) + pertuzumab (420 mg) Cohort C: Alpelisib 200mg + trastuzumab (6mg/kg) + pertuzumab (420 mg)
Group III: Part 2: Alpelisib matching Placebo + Trastuzumab + PertuzumabPlacebo Group3 Interventions
Trastuzumab (6mg/kg) + pertuzumab (420 mg) in combination with 200 mg alpelisib matching placebo, with potential for intra-participant dose escalation to 250 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Alpelisib
2018
Completed Phase 3
~900
Pertuzumab
2014
Completed Phase 3
~7500
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,330 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 been diagnosed with type I diabetes or my type II diabetes is not under control.I am fully active or restricted in physically strenuous activity but can do light work.I've had up to 8 treatments with specific drugs for my cancer, or stopped at 4-5 due to side effects.My bone marrow and organs are functioning well.My tumor has a PIK3CA mutation as confirmed by a specific test.I have been diagnosed with inflammatory breast cancer.I have serious heart problems that are not under control.I have been diagnosed with pneumonitis or interstitial lung disease.You have had Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN) in the past.My cancer got worse during the initial treatment before starting alpelisib.I have had acute pancreatitis within the last year or a history of chronic pancreatitis.My breast cancer is HER2-positive and cannot be removed by surgery or has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Alpelisib + Trastuzumab + Pertuzumab
- Group 2: Part 2: Alpelisib + Trastuzumab + Pertuzumab
- Group 3: Part 2: Alpelisib matching Placebo + Trastuzumab + Pertuzumab
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the conditions that Alpelisib is indicated to treat?
"Alpelisib is often used in the treatment of breast cancer, but it has also been shown to be effective against high risk of recurrence and first line treatment."
Answered by AI
To what extent has Alpelisib been studied in the past?
"Alpelisib was first studied two decades ago at Ospedale di Circolo e Fondazione Macchi. There have been 397 completed trials of the medication since then. As of now, there are 236 clinical trials underway that are recruiting patients. Many of these studies are being conducted out of Kingwood, New york."
Answered by AI
Is Alpelisib a safe medication for patients to take?
"We have given Alpelisib a score of 3 for safety. This is because it is a Phase 3 trial, which means that there is both some evidence of its efficacy and multiple rounds of data supporting its safety."
Answered by AI
Are people currently being accepted into this experiment?
"This clinical trial, as listed on clinicaltrials.gov, is seeking patients at this time. The trial was first posted on 7/16/2020 and was last updated on 10/21/2022."
Answered by AI
What are the overarching goals of this research?
"The sponsor of this clinical trial, Novartis Pharmaceuticals, reports that the primary outcome being measured over a six-week period is progression-free survival (PFS). Additionally, this trial will observe secondary outcomes such as PFS based on local radiology assessments, clinical benefit rate (CBR) with confirmed response, and alpelisib concentrations by timepoint and dose level."
Answered by AI
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