Breast CancerPhase 2Cornerstone001NCT05163223
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
A Phase 2 study testing AST-301(pNGVL3-hICD), rhuGM-CSF and Pembrolizumab in people with Breast Cancer, run by Aston Sci. Inc. at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AST-301(pNGVL3-hICD), rhuGM-CSF and Pembrolizumab
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 28 Feb 2022to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States10 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
University of Illinois Cancer Center
Chicago, Illinois, 60612
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43623
Scripps Health
La Jolla, California, 92037
Nebraska Cancer Specialist
Omaha, Nebraska, 68130
Providence Cancer Institute
Portland, Oregon, 97213
University of Washington
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
Taiwan7 sites
Changhua Christian Hospital
Changhua, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
China Medical University Hospital
Taichung, 404
Chi Mei Medical Center
Tainan, 710
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 11259
National Taiwan University Hospital
Taipei, 112
Taipei Veterans General Hospital
Taipei, 112
About this study
Official 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)
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.
Read more
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).
Read the detailed description
Not provided
- Conditions
- Breast Cancer
- Being tested
- AST-301(pNGVL3-hICD), rhuGM-CSF, Placebo, Pembrolizumab, Capecitabine
- Keywords
- HER 2 low (1+ or 2+ and non-amplified by FISH)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AST-301(pNGVL3-hICD)Biological
Also called AST-301
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
rhuGM-CSFDrug
Also called Leukine, Sargramostim
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
PlaceboDrug
Also called Normal Saline
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
PembrolizumabDrug
Also called Keytruda
Q3W; IV infusion
CapecitabineDrug
Also called Xeloda
On days 1-14 (Q3W), BID ; Oral administration,
| Study group | Role | What they receive |
|---|---|---|
| AST-301(pNGVL3-hICD)+Chemotherapy | Experimental | * 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) Receives: Biological: AST-301(pNGVL3-hICD); Drug: rhuGM-CSF; Drug: Pembrolizumab; Drug: Capecitabine |
| Placebo + Chemotherapy | Active comparator | * 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) Receives: Drug: rhuGM-CSF; Drug: Placebo; Drug: Pembrolizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year invasive disease free survival rate (iDFS)
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)
Measured: Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.
Secondary outcomes (4)
AST-301 specific T cell immune responses
Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Measured: Up to approximately 82 weeks
Change in central memory T cell populations
Assessment by FACS
Measured: Up to approximately 82 weeks
Distant Recurrence-Free Survival rate, dRFS rate
dRFS rate at the end of study
Measured: Overall study period approximately up to 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE
To assess safety of AST-301 administered in breast cancer patients.
Measured: Overall study period approximately up to 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start28 Feb 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston Sci. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163223
- Sponsor's protocol ID
- PN-301-21
- Acronym
- Cornerstone001
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2021
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05163223
- Acronym / sponsor ID
- Cornerstone001 / PN-301-21
- Conditions
- Breast Cancer
- Keywords
- HER 2 low (1+ or 2+ and non-amplified by FISH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aston Sci. Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Not provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AST-301(pNGVL3-hICD)+Chemotherapy | Experimental | Biological: AST-301(pNGVL3-hICD), Drug: rhuGM-CSF, Drug: Pembrolizumab, Drug: Capecitabine* 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) |
| Placebo + Chemotherapy | Active comparator | Drug: rhuGM-CSF, Drug: Placebo, Drug: Pembrolizumab, Drug: Capecitabine* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AST-301(pNGVL3-hICD)Also: AST-301Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection | Biological | AST-301(pNGVL3-hICD)+Chemotherapy |
| rhuGM-CSFAlso: Leukine, SargramostimQ3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection | Drug | AST-301(pNGVL3-hICD)+Chemotherapy, Placebo + Chemotherapy |
| PlaceboAlso: Normal SalineQ3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection | Drug | Placebo + Chemotherapy |
| PembrolizumabAlso: KeytrudaQ3W; IV infusion | Drug | AST-301(pNGVL3-hICD)+Chemotherapy, Placebo + Chemotherapy |
| CapecitabineAlso: XelodaOn days 1-14 (Q3W), BID ; Oral administration, | Drug | AST-301(pNGVL3-hICD)+Chemotherapy, Placebo + Chemotherapy |
Primary outcome
2-year invasive disease free survival rate (iDFS)
Time frame: Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.
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)
4 secondary outcomes
AST-301 specific T cell immune responses
Time frame: Up to approximately 82 weeks
Change in central memory T cell populations
Time frame: Up to approximately 82 weeks
Distant Recurrence-Free Survival rate, dRFS rate
Time frame: Overall study period approximately up to 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE
Time frame: Overall study period approximately up to 4years
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AST-301(pNGVL3-hICD), rhuGM-CSF and Pembrolizumab in people with Breast Cancer, run by Aston Sci. Inc. at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year invasive disease free survival rate (iDFS) (time frame: Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.