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Cancer Vaccine for Breast Cancer (Cornerstone001 Trial)
Phase 2
Recruiting
Research Sponsored by Aston Sci. Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)
HER 2 1+ by IHC or HER2 2+ by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.
Awards & highlights
Cornerstone001 Trial Summary
This trial is to study a new cancer vaccine to see if it is effective and safe in patients with HER2-low expression and hormone receptor-negative breast cancer.
Who is the study for?
This trial is for patients with a specific type of breast cancer that's HER2-low and hormone receptor-negative, who still have cancer after initial treatment. They should be in good health overall, not pregnant or breastfeeding, free from infections like HIV or hepatitis, and without autoimmune diseases.Check my eligibility
What is being tested?
The study tests a new cancer vaccine (AST-301) combined with standard therapy against a placebo plus standard therapy in breast cancer patients post-surgery. The vaccine is given three times every three weeks with an additional booster at six months.See study design
What are the potential side effects?
Possible side effects may include reactions to the vaccine such as redness or pain at the injection site, flu-like symptoms, fatigue, and potential immune system responses due to activation by the vaccine.
Cornerstone001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer was stage I, II, or III before surgery.
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My cancer is HER2 low according to specific guidelines.
Select...
My cancer is not driven by estrogen or progesterone hormones.
Select...
I still have cancer in my breast after initial treatment.
Select...
I am fully active or can carry out light work.
Cornerstone001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2-year invasive disease free survival rate (iDFS)
Secondary outcome measures
AST-301 specific T cell immune responses
Change in central memory T cell populations
Distant Recurrence-Free Survival rate, dRFS rate
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Cornerstone001 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AST-301(pNGVL3-hICD)+ChemotherapyExperimental Treatment4 Interventions
AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy*
A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination
Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)
Group II: Placebo + ChemotherapyActive Control4 Interventions
Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy*
A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination
Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rhuGM-CSF
2014
Completed Phase 2
~70
Pembrolizumab
2017
Completed Phase 2
~2010
Capecitabine
2013
Completed Phase 3
~3420
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for breast cancer, particularly those targeting HER2-expressing cells, include monoclonal antibodies like trastuzumab and pertuzumab, which bind to the HER2 receptor and inhibit cell proliferation. Additionally, therapeutic cancer vaccines like AST-301 aim to stimulate the immune system to recognize and attack HER2-positive cancer cells.
These treatments are crucial for breast cancer patients as they offer targeted therapy, potentially reducing tumor growth and recurrence while minimizing damage to healthy cells. This targeted approach can lead to better outcomes and fewer side effects compared to traditional chemotherapy.
Therapeutic dendritic cell vaccination of patients with renal cell carcinoma.
Therapeutic dendritic cell vaccination of patients with renal cell carcinoma.
Find a Location
Who is running the clinical trial?
Aston Sci. Inc.Lead Sponsor
3 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer was stage I, II, or III before surgery.I am currently on immune suppression therapy or was on it within the last 4 weeks.I do not have active infections like TB, hepatitis B, C, or HIV.My cancer is HER2 low according to specific guidelines.My cancer is not driven by estrogen or progesterone hormones.I haven't had cancer, except for non-dangerous skin cancer or localized cancer, in the last 5 years.My organs are functioning well.I still have cancer in my breast after initial treatment.You have had a disease that makes your immune system attack your own body, or a condition that causes inflammation.You have had a bad reaction to rhGM-CSF in the past.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: AST-301(pNGVL3-hICD)+Chemotherapy
- Group 2: Placebo + Chemotherapy
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.
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