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Cancer Vaccine
TPIV100 + Sargramostim for Breast Cancer
Phase 2
Recruiting
Led By Saranya Chumsri
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed adenocarcinoma of the breast stage >= T2 OR >= N1 based on the 7th edition of tumor, node, metastases (TNM) staging system from the American Joint Committee on Cancer
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying whether a combination of TPIV100 and sargramostim is effective in treating patients with HER2 positive, stage II-III breast cancer that has residual disease after chemotherapy.
Who is the study for?
This trial is for HER2 positive, stage II-III breast cancer patients with residual disease post-chemotherapy and surgery. Participants must have completed all planned surgeries and any radiation at least 30 days prior, have a certain level of blood cell counts, be willing to provide tissue/blood samples, use contraception if applicable, and not be pregnant. They should also have an ECOG performance status of 0-2.Check my eligibility
What is being tested?
The trial is testing the effectiveness of TPIV100 (a vaccine targeting HER2 peptides) combined with sargramostim (which boosts white blood cells) in treating breast cancer that remains after initial treatments. It's also exploring why some patients respond better to chemotherapy when paired with trastuzumab and pertuzumab.See study design
What are the potential side effects?
Potential side effects may include typical vaccine-related reactions like soreness or redness at the injection site, flu-like symptoms such as fever or chills, fatigue from immune system activation by TPIV100, and possible increase in white blood cells due to sargramostim which could lead to bone pain or skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is at least stage T2 or N1.
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I can take care of myself but may not be able to do heavy physical work.
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I finished my last chemotherapy cycle more than 90 days ago.
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I still have a tumor larger than 1 cm in my breast or cancer in my lymph nodes after treatment.
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I can take care of myself but may not be able to do heavy physical work.
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My cancer is HER2 positive, confirmed by specific tests.
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
Invasive disease-free survival (iDFS) between the 2 arms
Secondary outcome measures
Complete pathological response
Immunogenicity assessment
Incidence of adverse events (AEs)
+2 moreSide 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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment (pCR)Experimental Treatment2 Interventions
Patients receive standard of care maintenance therapy with trastuzumab and pertuzumab for 1 year in the absence of disease progression or unacceptable toxicity.
Group II: Arm I - No pCR (trastuzumab emtansine, TPIV100, sargramostim)Experimental Treatment3 Interventions
Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive TPIV100 ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of TPIV100 ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
Group III: Arm II - No pCR (trastuzumab emtansine, placebo, sargramostim)Placebo Group3 Interventions
Patients receive standard of care maintenance therapy with trastuzumab emtansine and receive placebo ID and sargramostim ID on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive two additional booster injections of placebo ID and sargramostim ID at 3 and 12 months after completion of trastuzumab emtansine maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Pertuzumab
2014
Completed Phase 3
~7500
Sargramostim
2008
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,583 Total Patients Enrolled
83 Trials studying Breast Cancer
13,810 Patients Enrolled for Breast Cancer
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
4,656 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,525 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication like tamoxifen to prevent breast cancer within the last 2 months.Your hemoglobin level is at least 9.0 grams per deciliter, as measured within the past 28 days before the study starts.Your heart's pumping ability is less than 50%.Your creatinine level is not more than twice the upper limit of normal.I have provided enough biopsy samples from before and after treatment.I do not have any uncontrolled medical conditions.My breast cancer is at least stage T2 or N1.Your AST level in the blood is not more than 3 times the normal limit.I have a weakened immune system, either due to HIV or long-term steroid use.I can take care of myself but may not be able to do heavy physical work.My blood clotting tests are normal or managed if I'm on blood thinners.Women who can have children must have a negative pregnancy test within 7 days before joining the study.Women capable of getting pregnant must have a negative pregnancy test within 7 days before joining the study.I am breastfeeding and not willing to stop.I finished my breast cancer surgery and any radiation therapy over 30 days ago.I have not had any other cancer within the last 3 years.I am willing to get a tetanus shot if I haven't had one in the last year.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your blood test shows you have enough infection-fighting white blood cells.I haven't had a heart attack in the last 6 months or heart failure needing ongoing treatment.I still have side effects from my last chemotherapy that haven't gone away.Your platelet count is at least 75,000 per cubic millimeter.You had a bad reaction to GM-CSF before.I had heart issues from trastuzumab treatment but my heart function has recovered.I have an autoimmune disease treated with medication in the last 30 days.My blood clotting tests are normal or in the expected range if I'm on blood thinners.My blood clotting tests are normal or managed if I'm on blood thinners.Your body has enough infection-fighting white blood cells.Your kidney function, as measured by a blood test called creatinine, should be within a certain range.I finished my last chemotherapy cycle more than 90 days ago.I finished my last chemotherapy session more than 90 days ago.My cancer has returned or spread to other parts of my body.You must have a negative pregnancy test within 7 days before joining the study, if you could become pregnant.Your bilirubin levels are within a certain range, which means your liver is working properly.Your liver function test results must show that your AST level is not more than three times the upper limit of normal.Your direct bilirubin level should be less than 1.5 times the upper limit of normal.I still have a tumor larger than 1 cm in my breast or cancer in my lymph nodes after treatment.I can take care of myself but may not be able to do heavy physical work.Your platelet count should be at least 75,000 per cubic millimeter of blood within the last 28 days before joining the study.My cancer is HER2 positive, confirmed by specific tests.I still have cancer after treatment with trastuzumab and possibly pertuzumab.Your kidneys are working well, with a clearance of at least 50 milliliters of creatinine per minute.Your hemoglobin level should be at least 9.0 grams per deciliter, which will be checked within 28 days before you join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I - No pCR (trastuzumab emtansine, TPIV100, sargramostim)
- Group 2: Arm II - No pCR (trastuzumab emtansine, placebo, sargramostim)
- Group 3: Treatment (pCR)
Awards:
This trial has 0 awards, including: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.
Are patients being accepted into this experiment at this time?
"That is accurate. As of right now, the clinical trial is looking for 480 patients between 14 sites. The trial was first posted on 2/20/2020 and was last edited on 10/18/2022 according to clinicaltrials.gov"
Answered by AI
How many people are being recruited for this clinical trial?
"In order to move forward with this research, 480 individuals who fit the bill in terms of specified inclusion criteria are needed. Patients can choose to participate at facilities such as Mayo Clinic located in Rochester, Minnesota and University of Arizona Cancer Center-North Campus found in Tucson, California."
Answered by AI
Could you please explain what other research studies have been conducted that included Trastuzumab?
"Currently, there are 266 ongoing studies that focus on Trastuzumab. Out of these investigations, 61 are classified as Phase 3 trials. The largest concentration of these research projects is located in Seattle, Washington; however, there are 18494 total locations where Trastuzumab trials are taking place."
Answered by AI
Has the Food and Drug Administration greenlit Trastuzumab?
"Trastuzumab has received a 2 for safety. While there is some data supporting its safety, none of it backs up the efficacy of the medication."
Answered by AI
Is this clinical trial popular in city?
"Currently, there are 14 sites across the globe enrolling patients for this trial. If you're considering enrolling, know that locations include Rochester, Tucson and Scottsdale. To reduce travel burden, try to select a location close to your home."
Answered by AI
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