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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05163223
Registration number
NCT05163223
Ethics application status
Date submitted
2/04/2021
Date registered
20/12/2021
Date last updated
20/07/2023
Titles & IDs
Public title
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
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Scientific title
A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)
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Secondary ID [1]
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PN-301-21
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Universal Trial Number (UTN)
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Trial acronym
Cornerstone001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - AST-301(pNGVL3-hICD)
Treatment: Drugs - rhuGM-CSF
Treatment: Drugs - Placebo
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Capecitabine
Experimental: AST-301(pNGVL3-hICD)+Chemotherapy - 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)
Active Comparator: Placebo + Chemotherapy - 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)
Other interventions: AST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Treatment: Drugs: rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Treatment: Drugs: Placebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Treatment: Drugs: Pembrolizumab
Q3W; IV infusion
Treatment: Drugs: Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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2-year invasive disease free survival rate (iDFS)
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Assessment method [1]
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iDFS event is defined as Ipsilateral breast tumor recurrence Local/regional invasive recurrence Distant recurrence Invasive contralateral breast cancer Death (from breast cancer/non-breast cancer cause/unknown cause) Secondary primary invasive cancer (non-breast)
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Timepoint [1]
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Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.
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Secondary outcome [1]
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AST-301 specific T cell immune responses
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Assessment method [1]
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Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay
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Timepoint [1]
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Up to approximately 82 weeks
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Secondary outcome [2]
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Change in central memory T cell populations
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Assessment method [2]
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Assessment by FACS
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Timepoint [2]
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Up to approximately 82 weeks
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Secondary outcome [3]
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Distant Recurrence-Free Survival rate, dRFS rate
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Assessment method [3]
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dRFS rate at the end of study
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Timepoint [3]
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Overall study period approximately up to 4 years
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Secondary outcome [4]
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Number of participants with treatment-related adverse events as assessed by CTCAE
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Assessment method [4]
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To assess safety of AST-301 administered in breast cancer patients.
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Timepoint [4]
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Overall study period approximately up to 4years
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Eligibility
Key inclusion criteria
Key
- Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment
- 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.
- Hormone receptor (ER and PR) negative by ASCO/CAP guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a history of hypersensitivity or other contraindications to rhGM-CSF
- Has a history of invasive malignancy =5 years prior to first administration of
investigational drug except for adequately treated non-melanoma skin cancer or
carcinoma in situ.
- Is on immune suppression therapy or has a history of immune suppression therapy =4
weeks prior to the first administration of investigational drugs
- Has a history of autoimmune disease or inflammatory disease
- Has active infection including tuberculosis, hepatitis B, hepatitis C or human
immunodeficiency virus (HIV) infection
- Is pregnant or breastfeeding or expecting to conceive children
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
146
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Nebraska
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Oregon
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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Taiwan
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State/province [9]
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Changhua City
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Country [10]
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Taiwan
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State/province [10]
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Kaohsiung
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Country [11]
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Taiwan
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State/province [11]
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Taichung City
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Country [12]
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Taiwan
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State/province [12]
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Tainan
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Country [13]
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Taiwan
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State/province [13]
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Taipei city
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Country [14]
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Taiwan
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State/province [14]
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Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Aston Sci. Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of
therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC
1+ or 2+ and ISH-) and hormone receptor-negative(ER-, PR-) breast cancer with residual
disease after neoadjuvant treatment.
Patients will be randomized 1:1 to either the Experimental arm (combination of AST-301/rhuGM
CSF and standard adjuvant therapy) or the Control arm (combination of placebo/rhuGM CSF and
standard adjuvant therapy). Standard adjuvant chemotherapy will be pembrolizumab or
capecitabine.
Adjuvant therapy will be administered in compliance with the NCCN guideline for breast cancer
(Version 8, 2021), and IP (AST-301) will be administered 3 times every 3 weeks in the
adjuvant treatment period, with a booster administered at 24 weeks (±7 days) post the third
dose of IP administration.
Survival follow up will be performed to determine invasive Disease Free survival(iDFS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05163223
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Eunkyo Joung, CMO
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Address
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Country
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Phone
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02-2038-2347
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05163223
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