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Alpha-TEA + Trastuzumab for Breast Cancer
Phase 1
Recruiting
Led By William Gwin, MD
Research Sponsored by Veana Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received recommended first therapy with a Taxane, with trastuzumab and/or pertuzumab and second line therapy with Kadcyla or ENHERTU, or unable to tolerate these therapies
Patients with HER2/neu overexpressing metastatic breast, not considered curable by conventional therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing the effects of a new drug, alpha-TEA, when given with the existing drug trastuzumab, for the treatment of HER2+ breast cancer that has stopped responding to other treatments and has spread to other parts of the body.
Who is the study for?
This trial is for adults with HER2+ metastatic breast cancer that's resistant to standard treatments. Participants must have tried specific therapies, can swallow capsules, and have good heart function. They should not be on certain medications or supplements and must agree to contraception if applicable.Check my eligibility
What is being tested?
The trial tests the combination of alpha-TEA (a potential immune-stimulating anti-cancer agent) with trastuzumab (a targeted therapy blocking growth signals in cancer cells). It aims to find the safest dose and see if this combo is more effective than usual treatments for advanced breast cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune stimulation, issues from capsule ingestion, and typical risks associated with targeted therapies like trastuzumab which may affect heart function or cause infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had first and second line treatments for my cancer, or couldn't tolerate them.
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My breast cancer is advanced, spreads, and not curable by standard treatments.
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I will continue taking trastuzumab or its equivalents throughout the study.
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My cancer is HER2 positive according to the latest guidelines.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical response rate of alpha-TEA when combined with trastuzumab
Incidence of adverse events of 4 escalating doses of alpha-tocopheryloxyacetic acid (TEA) therapy when combined with trastuzumab
Secondary outcome measures
Change in level of activated effector memory CD4+ and CD8+ T-cells at 4 escalating doses of alpha-TEA and concurrent trastuzumab
Change in the number of HER2 specific T cells at each dose level
Modulation of circulating natural killer (NK) cells with concurrent alpha-TEA and trastuzumab therapy
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (alpha-TEA, trastuzumab)Experimental Treatment2 Interventions
Patients receive one of 4 doses of alpha-TEA PO on days 1-14 of each cycle. Patients also receive trastuzumab on day 1 of cycle 1 and then every 3 weeks per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Veana TherapeuticsLead Sponsor
Veana Therapeutics, Inc.UNKNOWN
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,742 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had first and second line treatments for my cancer, or couldn't tolerate them.I am not pregnant and will avoid pregnancy during and after the treatment.You have a disease outside of the bones that can be measured using a specific guideline called RECIST 1.1.Your recent lab test results must be within certain ranges.My breast cancer is advanced, spreads, and not curable by standard treatments.I do not have active brain metastases or conditions affecting study participation.My breast cancer is ER/PR positive and I may keep taking anti-estrogen therapy.I haven't taken long-term immune-weakening drugs in the last 14 days, except for short steroid courses.I haven't taken strong CYP3A4/5 inhibitors or inducers in the last 2 weeks.I have not had surgery or severe trauma in the last 4 weeks.It has been over 14 days since my last chemotherapy treatment.I have recovered from any major infections or surgeries and don't have other serious illnesses.I have heart conditions, fluid around my heart, or irregular heartbeats.My heart's electrical activity is abnormal, or I have an active heart disease.My heart's pumping ability is normal, confirmed by a recent heart scan.I am currently being treated for a significant autoimmune disease.I will not father a child during or for 4 weeks after my α-TEA treatment.My thyroid function is not normal, or I am on medication for a thyroid condition but my thyroid levels are currently normal.I will continue taking trastuzumab or its equivalents throughout the study.My cancer is HER2 positive according to the latest guidelines.I haven't taken Vitamin E supplements for at least two weeks.I am currently on bisphosphonates or hormone therapy and can continue it.I can take care of myself and am up and about more than half of my waking hours.I may or may not have taken Lapatinib for cancer that has spread.I have a condition that affects how my body absorbs nutrients due to surgery or diseases like ulcerative colitis.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (alpha-TEA, trastuzumab)
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.
What level of security can be expected when utilizing Trastuzumab for treatment?
"The safety of Trastuzumab was assessed as a 1 on our company's rating system due to the limited clinical data available for Phase 1 trials."
Answered by AI
How many participants are enrolled in this experiment?
"Correct. According to the clinicaltrials.gov listing, this medical study was first posted on April 8th 2020 and is currently accepting participants. The trial requires 24 individuals from a single center for enrollment."
Answered by AI
Are there remaining vacancies for potential participants in this clinical trial?
"The information residing on clinicaltrials.gov substantiates that this medical study is presently taking applicants, with the original post being dated April 8th 2020 and a recent update occurring June 17 2022."
Answered by AI
Which maladies is Trastuzumab most commonly employed to combat?
"Trastuzumab is often utilized for the treatment of brca1 gene-related ailments. In addition, it can prove effective in helping patients cope with infection, inflammatory breast cancer (IBC), and general breast issues."
Answered by AI
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