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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 below
Select...
My cancer was stage I, II, or III before surgery.
Select...
My cancer is HER2 low according to specific guidelines.
Select...
My cancer is not driven by estrogen or progesterone hormones.
Select...
My organs are functioning well.
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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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall study period approximately up to 4years (end of study in this study is defined as 2years frm the date of last patient in. for reporting.

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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
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

Find a Location

Who is running the clinical trial?

Aston Sci. Inc.Lead Sponsor
3 Previous Clinical Trials
141 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT05163223 — Phase 2
Breast Cancer Research Study Groups: AST-301(pNGVL3-hICD)+Chemotherapy, Placebo + Chemotherapy
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05163223 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163223 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the conditions that Pembrolizumab is most often used to manage?

"Pembrolizumab can be used to target and treat refractory, relapsed mediastinal large b-cell lymphoma, refractory fallopian tube carcinoma, and leukemia, myelocytic, acute."

Answered by AI

Does this study still have room for new participants?

"Yes, the information on clinicaltrials.gov says that this study is presently searching for candidates. The clinical trial was originally posted on 2/28/2022 and was last edited on 5/2/2022. The trial is looking for 146 patients across 1 locations."

Answered by AI

How many individuals are being observed in this clinical trial

"Yes, as indicated on clinicaltrials.gov, this trial is looking for enrollees at the present moment. The first posting was on February 28th, 2022 and the most recent update was on May 2nd, 2022. So far, 1 site has enrolled 146 patients."

Answered by AI

Has Pembrolizumab received regulatory approval from the FDA?

"Pembrolizumab falls into the Phase 2 category, meaning that while there is evidence of its safety, currently there is no data to support efficacy."

Answered by AI

What other drugs has Pembrolizumab been tested with in previous clinical trials?

"Pembrolizumab is being studied in 1364 active clinical trials, with 251 of them being Phase 3 studies. While some of these investigations are taking place in Houston, Texas, there are 48889 total research sites for Pembrolizumab across the globe."

Answered by AI
~57 spots leftby Aug 2025