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PI3K Inhibitor
Alpelisib + Tucatinib for Breast Cancer
Phase 1 & 2
Recruiting
Led By Elena Shagisultanova, MD
Research Sponsored by Criterium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented presence of activating mutation in PIK3CA in the tumor
Known ER and PR status of the tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat metastatic breast cancer that is positive for the HER2 gene.
Who is the study for?
This trial is for adults with HER2-positive metastatic breast cancer that has a specific mutation (PIK3CA). Participants must understand the study and be willing to follow its procedures. They should have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. People with severe medical conditions, recent anti-cancer therapy, pregnancy, certain drug hypersensitivities, or inability to swallow pills cannot join.Check my eligibility
What is being tested?
The trial is testing the combination of Alpelisib and Tucatinib with Fulvestrant in patients who have PIK3CA-Mutant HER2+ metastatic breast cancer. It's designed to see how safe this combo is and how well it works compared to standard treatments.See study design
What are the potential side effects?
Alpelisib may cause high blood sugar levels, rash, nausea, fatigue and diarrhea. Tucatinib can lead to diarrhea as well as liver issues and mouth sores. Fulvestrant might result in injection site pain, weakness or bone pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has a PIK3CA mutation.
Select...
I know my tumor's estrogen and progesterone receptor status.
Select...
My breast cancer is advanced, cannot be surgically removed, and is HER2 positive.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II Efficacy of tucatinib combination evaluated by progression free survival (PFS)
Phase Ib Safety and Tolerability of alpelisib and tucatinib combination, summary of all AEs and SAEs on study as evaluated by NCI-CTCAE v 5.0
Secondary outcome measures
Phase II Duration of Reponse (DOR)
Phase II Incidence, nature and severity of all AEs that occur on or after C1D1 of therapy
Phase II Tumor response evaluation
+3 moreSide effects data
From 2023 Phase 2 trial • 117 Patients • NCT0304331364%
Diarrhoea
43%
Fatigue
34%
Nausea
21%
Infusion related reaction
20%
Pyrexia
19%
Chills
19%
Decreased appetite
19%
Dermatitis acneiform
17%
Hypertension
16%
Arthralgia
16%
Vomiting
16%
Back pain
16%
Cough
14%
Constipation
14%
Abdominal pain
14%
Dyspnoea
13%
Myalgia
10%
Anxiety
10%
Anaemia
9%
Headache
9%
Pruritus
9%
Dry skin
9%
Pain in extremity
8%
Rash maculo-papular
8%
Peripheral sensory neuropathy
8%
Insomnia
8%
Influenza like illness
8%
Dehydration
8%
Oedema peripheral
8%
Nasal congestion
7%
Productive cough
7%
Upper-airway cough syndrome
7%
Weight decreased
7%
Muscle spasms
7%
Epistaxis
6%
Hypokalaemia
6%
Rhinitis allergic
6%
COVID-19
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
5%
Dry mouth
5%
Oropharyngeal pain
5%
Dizziness
5%
Nephrolithiasis
5%
Rash
5%
Ejection fraction decreased
5%
Musculoskeletal chest pain
5%
Abdominal pain upper
5%
Haematuria
5%
Urinary tract infection
5%
Dysgeusia
5%
Flank pain
3%
Blood creatinine increased
3%
Pollakiuria
3%
Asthenia
3%
Gastrooesophageal reflux disease
3%
Dysuria
3%
Vision Blurred
3%
Flatulence
3%
Non-cardiac chest pain
3%
Large intestinal obstruction
3%
Dyspepsia
3%
Fall
3%
Small intestinal obstruction
3%
Hyponatraemia
3%
Rhinorrhoea
3%
Wheezing
3%
Hypercreatinaemia
2%
Herpes zoster
2%
Abdominal distension
2%
Thrombocytopenia
2%
Abdominal discomfort
2%
Rectal haemorrhage
2%
Influenza
2%
Blood alkaline phosphatase increased
2%
Blepharospasm
2%
Rhinitis
2%
Gastrointestinal pain
2%
Nail infection
2%
Pelvic pain
2%
Peripheral swelling
2%
COVID-19 pneumonia
2%
Onychomadesis
2%
Rectal perforation
2%
Muscular weakness
2%
Weight increased
2%
Dysphonia
2%
Erythema
2%
Nail disorder
2%
Urticaria
2%
Hypoalbuminaemia
2%
Dyspnoea exertional
2%
Pulmonary embolism
2%
Sinus pain
1%
Acute kidney injury
1%
Hypotension
1%
Sepsis
1%
Cholangitis
1%
Bile duct stone
1%
Cancer pain
1%
Angina unstable
1%
Colitis
1%
Gastrointestinal obstruction
1%
Kidney infection
1%
Renal colic
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tucatinib+Trastuzumab (Cohorts A+B)
Cohort C (Pre-Crossover)
Cohort C (Post-Crossover)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ib Safety Cohort /II Expansion CohortExperimental Treatment3 Interventions
In phase Ib, the tolerability of tucatinib and alpelisib combination will be confirmed and maximum tolerated dose determined. Therapy will be administered in 28 day cycles of tucatinib 300 mg PO BID and alpelisib 250 mg PO daily (dose level 1). Treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. Fulvestrant will also be administered in patients with HR+/HER2+ metastatic breast cancer. Once RP2D is determined, the study will be continued to phase II, and new patients will enroll at RP2D. All patients in phase IB part, who are remaining on study at the time of initiation of phase II, will be rolled over to phase II. At that time, their study drug doses will be modified as follows: (1) if a patient is on the drug doses lower than RP2D, doses will not be increased; (2) if a patient is on a higher doses compared to RP2D, doses of study drugs will be changed to RP2D.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Tucatinib
2017
Completed Phase 2
~520
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Seagen Inc.Industry Sponsor
208 Previous Clinical Trials
74,188 Total Patients Enrolled
6 Trials studying Breast Cancer
3,308 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,995 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer
Criterium, Inc.Lead Sponsor
16 Previous Clinical Trials
734 Total Patients Enrolled
4 Trials studying Breast Cancer
216 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a disease that can be measured or evaluated using specific criteria.I haven't taken any forbidden medications recently.I haven't had any cancer treatment or surgery in the last 14 days.I cannot swallow pills or have a stomach condition affecting medication absorption.I have been treated with alpelisib or similar drugs for over a month.My tumor has a PIK3CA mutation.I've had more than one treatment with specific cancer drugs for my advanced cancer.I have type 1 diabetes or my type 2 diabetes is not under control.I have HIV with a CD4+ count below 350 cells/μL.I know my tumor's estrogen and progesterone receptor status.My organs and bone marrow are working well.My breast cancer is advanced, cannot be surgically removed, and is HER2 positive.My breast cancer is either HR- HER2+ or HR+ HER2+.I haven't had a heart attack or major heart procedure in the last 6 months.I do not have serious heart conditions like uncontrolled high blood pressure or heart failure.I do not have active hepatitis B, hepatitis C, or HIV.After a brain MRI, no specific issues should be found.I have had acute pancreatitis in the last year or suffer from chronic pancreatitis.You have had serious skin reactions like Steven Johnson syndrome or toxic epidermal necrolysis in the past.You cannot have an MRI with contrast dye for your brain.I am 18 years old or older.I am fully active or can carry out light work.I am not currently on IV treatments for infections.Brain MRI with contrast will be used to determine if you meet the criteria for the study.The doctor believes you will live for at least 6 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Ib Safety Cohort /II Expansion Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is the recruitment process still open for this clinical experiment?
"Affirmative. The clinicaltrials.gov website indicates that this medical trial was first published on August 25th 2022 and has been actively recruiting participants since then. 40 volunteers are wanted for the two designated sites involved in this study."
Answered by AI
What is the cap on participation for this research trial?
"Affirmative. Clinicaltrials.gov hosts data that verify this medical investigation is actively enrolling participants, having been initially posted on August 25th 2022 and updated most recently on October 14th 2022. The study requires 40 patients between 2 trial locations to be recruited."
Answered by AI
What goals is this research endeavor striving to accomplish?
"According to Seagen Inc., the trial's sponsor, Phase Ib Safety and Tolerability of alpelisib and tucatinib combination—as evaluated by NCI-CTCAE v 5.0—will be measured over a 20 Month period as the primary outcome. Secondary outcomes will include tumor response evaluations (CR, PR or SD according to RECIST 1.1), overall response rate (ORR; CR & PR) and clinical benefit rate (CBR; CR, PR & SD). Duration of Response is also being monitored from enrolment into the trial until progression or mortality occurs first. Lastly, incidence and severity"
Answered by AI
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