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Chemotherapy
Vaccine + Chemotherapy + Monoclonal Antibody Therapy for Breast Cancer
Phase 2
Recruiting
Led By William Gwin
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018), regardless of estrogen receptor (ER)/ progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)
Patients must be at least >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a vaccine in combination with chemotherapy and targeted monoclonal antibody therapy before surgery to see if it is more effective at treating breast cancer and causes fewer side effects.
Who is the study for?
This trial is for adults with HER2+ stage I-III breast cancer who plan to undergo neoadjuvant therapy. They must have adequate organ function, agree to use contraception if of child-bearing potential, and not be on immunosuppressants or other investigational drugs. Exclusions include HIV-positive individuals, uncontrolled autoimmune diseases, recent major surgery, certain heart conditions, and known allergies to vaccine components.Check my eligibility
What is being tested?
The study tests the WOKVAC vaccine combined with chemotherapy (paclitaxel) and HER2-targeted monoclonal antibody therapy (trastuzumab and pertuzumab) before surgery in patients with breast cancer. The goal is to see if this combination can better stimulate the immune system to attack tumor cells compared to standard treatments alone.See study design
What are the potential side effects?
Possible side effects may include typical reactions at the injection site from vaccines, allergic responses, fatigue from chemotherapy drugs like paclitaxel, as well as heart issues or infusion-related reactions due to monoclonal antibodies trastuzumab and pertuzumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage I-III HER2+ breast cancer and will start treatment soon.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy
Secondary outcome measures
Incidence of adverse events
Somatomedins
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 (WOKVAC, paclitaxel, trastuzumab, pertuzumab)Experimental Treatment4 Interventions
Patients receive WOKVAC ID on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15, and trastuzumab IV and pertuzumab IV on day 1. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pertuzumab
2014
Completed Phase 3
~7500
Paclitaxel
2011
Completed Phase 4
~5380
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
863 Previous Clinical Trials
227,616 Total Patients Enrolled
37 Trials studying Breast Cancer
3,466 Patients Enrolled for Breast Cancer
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,922 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
William GwinPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have stage I-III HER2+ breast cancer and will start treatment soon.Your platelet count is at least 75,000 per microliter within the past 4 weeks before starting the study treatment.You are allergic to the GM-CSF adjuvant.I have not had major surgery in the last 4 weeks.I have had hepatitis B or C but it has been treated and cleared.I have diabetes that is not well-controlled.I am not currently using any immunosuppressive drugs or systemic corticosteroids.Your white blood cell count is at least 500 per cubic millimeter.I am using effective birth control methods and have a negative pregnancy test if applicable.Your total bilirubin level should be less than a certain number, unless you have Gilbert's syndrome, in which case it should be less than a higher number.My heart's pumping ability is within the normal range.I've had chemotherapy before but can only take specific medications for this study.I have serious heart conditions, including unstable chest pain or heart failure.I am 18 years old or older.Your AST and ALT levels are not more than three times the upper limit of normal.Your white blood cell count is at least 1,500 per microliter.I am HIV-positive.I am currently receiving treatment for an uncontrolled autoimmune disease.I am fully active or can carry out light work.My kidney function, measured by creatinine levels or clearance, is within the required range.Your white blood cell count is at least 3000 per cubic millimeter within the last 4 weeks before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab)
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 risks, if any, are associated with Paclitaxel use?
"Due to the lack of efficacy data, Paclitaxel's safety was rated a 2. This evaluation is based on it being a Phase 2 trial, which provides some insight into its potential risks."
Answered by AI
Are there any historical precedents for the use of Paclitaxel in clinical research?
"Currently, there are 978 clinical trials involving Paclitaxel; 258 of which are in their final phase. These studies can be found across 54366 research centres worldwide and Seattle, Washington has the highest concentration of them."
Answered by AI
What availability is there for enrolling in this medical trial?
"Affirmative. According to information uploaded onto clinicaltrials.gov, this medical trial is presently looking for participants; it was initially posted on April 20th 2022 and the last update was made August 1st 2022. There are 16 openings at one site that need to be filled."
Answered by AI
For what medical conditions is Paclitaxel commonly employed?
"Paclitaxel can be leveraged to treat metastatic bladder cancer, inflammatory breast cancer (IBC), and Acquired Immunodeficiency Syndrome."
Answered by AI
How many individuals are currently engaged in this experiment?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical trial, which was first advertised on April 20th 2022, is currently recruiting patients. 16 individuals must be sourced from a single centre for the study to continue."
Answered by AI
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