Breast Cancer
Conditions
Keywords
HER 2 low (1+ or 2+ and non-amplified by FISH)
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).
Detailed description
Not provided
Interventions
BIOLOGICALAST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
DRUGrhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
DRUGPlacebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
DRUGPembrolizumab
Q3W; IV infusion
DRUGCapecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Sponsors
Aston Sci. Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year invasive disease free survival rate (iDFS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST-301 specific T cell immune responses | Up to approximately 82 weeks | Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay |
| Change in central memory T cell populations | Up to approximately 82 weeks | Assessment by FACS |
| Distant Recurrence-Free Survival rate, dRFS rate | Overall study period approximately up to 4 years | dRFS rate at the end of study |
| Number of participants with treatment-related adverse events as assessed by CTCAE | Overall study period approximately up to 4years | To assess safety of AST-301 administered in breast cancer patients. |
Countries
Taiwan, United States
Outcome results
None listed