- Documented radiographic and histopathologic confirmed primary localized invasive
- Histologically documented TNBC (ER-/PR-/HER2-) defined as ER-negative and PR-negative
(≤5% positive cells stain by IHC for both ER and PR), and negative HER2/neu- status,
confirmed on tumor biopsy sample from surgery.
- HER2/neu negative will be defined as one of the following criteria:
- IHC 0 or 1+
- Single-probe average HER2 gene copy number of <6 signals/nucleus
- Dual-probe FISH HER2/neu chromosome 17 (CEP17) non-amplified ratio of <2
- Globo H IHC H-score ≥15 in the tumor tissue biopsy from the primary site/or lymph node
(if primary site is not available). The Globo H expression will be determined during
Pre-screening Phase by Central lab. Instructions for submission of slides/tumor
tissues block and pertinent reports to central review are provided in the study Lab
- No evidence of metastatic disease in chest, abdomen and pelvis by CT or MRI scan
during the Screening Phase. Historical report within 3 months prior to randomization
is acceptable as baseline scan. Bone scans and imaging of the brain at screening is
optional, and should be symptom directed.
- High risk patients meeting ONE of the following criteria:
- Neoadjuvant chemotherapy: Residual invasive disease following neoadjuvant
chemotherapy defined as: A contiguous focus of residual invasive cancer in the
breast measuring ≥1 cm in diameter with more than 1% cellularity and/or with
residual invasive cancer in at least one axillary node (as determined by local
- Primary surgery: Patients must have ≥4 axillary lymph nodes positive for invasive
cancer and have completed adjuvant chemotherapy
- Must have completed taxane (with or without platinum), and/or anthracycline-based
chemotherapy (either sequential or concurrent) either in the neoadjuvant or adjuvant
• Post-neoadjuvant chemotherapy with capecitabine or a platinum salt is allowed.
- Surgery for treatment of primary cancer must be completed at least 2 weeks, but no
more than 56 weeks, prior to randomization. Patients receiving neoadjuvant therapy who
are not receiving post-operative (adjuvant) chemotherapy must have completed their
final breast surgery no more than 32 weeks prior to randomization.
- All adjuvant chemotherapy and/or radiotherapy (if indicated) after surgery, must have
been completed at least 2 weeks prior to randomization.
- All treatment-related toxicities resolved to Grade <1 on National cancer institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0) criteria
(except hair loss and ≤Grade 2 neuropathy, which are acceptable).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Females must be either of non-childbearing potential, i.e., surgically sterilized
(have documented sterilization, bilateral oophorectomy/salpingectomy at least 3 months
before the start of the trial and/or hysterectomy), or one year postmenopausal; or if
of childbearing potential must have a negative pregnancy test (urine or serum) at
- Males and females of childbearing potential and their partners must be willing to use
effective contraception during the entire study treatment period (Section 9.4.9) and
for at least 8 weeks after the last dose of study treatment.
- Adequate hematological, hepatic and renal function as defined below:
- Absolute neutrophil count (ANC) ≥1,500/µL
- Platelets ≥75,000/µL
- Hemoglobin ≥8.5g/dL
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine
clearance ≥55 mL/min for subjects with creatinine levels >1.5 × institutional ULN
(glomerular filtration rate can also be used in place of creatinine or creatinine
clearance may be calculated per institutional standard)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN
- Alkaline Phosphatase (ALP) ≤2.5 × ULN
- Serum total bilirubin ≤1.5 × ULN (unless Gilbert's disease is documented)
- Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal,
by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- Consent to participate with a signed and dated IRB-approved patient informed consent
for the study prior to beginning any specific study procedures.
- Ability to understand and willingness to complete all protocol required procedures.
- Local recurrence of or previous history of contralateral invasive breast cancer within
10 years of the current diagnosis.
- Definitive clinical or radiologic evidence of metastatic disease
- Synchronous bilateral breast cancer, unless both tumors are confirmed as TNBC.
- Have received any systemic treatment for TNBC within 2 weeks prior to randomization.
- Have received neo/adjuvant anti-cancer treatment or immunotherapy with antigen,
antibody, immune checkpoint inhibitors (Programmed cell death-1/ Programmed cell
death-ligand-1inhibitors, anti-cytotoxic T lymphocyte associated protein 4 [CTLA 4]
therapy), or other anti-cancer vaccines within 4 weeks prior to randomization.
- For patients undergoing neoadjuvant chemotherapy, more than one line of chemotherapy
- A history of other malignancies (except non melanoma skin carcinoma, carcinoma in situ
of the uterine cervix, non-invasive follicular thyroid neoplasm and papillary thyroid
cancer) within 5 years prior to this breast cancer diagnosis.
- Have any active autoimmune disease or disorder that requires systemic
immunosuppressive/immunomodulatory therapy. NOTE: Autoimmune diseases that are
confined to the skin (e.g., psoriasis) that can be treated with topical steroids alone
are allowed during the study.
- Oral/parenteral corticosteroid treatment (>5 mg/day of prednisone/equivalent), within
2 weeks prior to randomization or anytime during the study. NOTE: inhaled steroids for
treatment of asthma; and topical steroids are allowed during the study.
- Any known uncontrolled concurrent illness that would limit compliance with study
requirements, including but not limited to ongoing or active infections, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric
disorders, or substance abuse.
- Any known hypersensitivity to active/inactive ingredients in the study drug
formulation or known severe allergy or anaphylaxis to fusion proteins.
- Receipt of any live, attenuated vaccine (including influenza vaccine, e.g., FluMist)
within 4 weeks prior to randomization and during the study till 4 weeks after the last
dose of study treatment. NOTE: inactivated vaccines (e.g., inactivated influenza
vaccines) are allowed during the study, if required.
- Prior receipt of a glycoconjugate vaccine.
- Known history or positive for human immunodeficiency virus (HIV positive)
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at
screening. Active infections are HBVsAg positive, HBV DNA ≥1000 cps/mL or 200 IU/mL or
positive HCV RNA test.
- Any condition, including significant diseases and/or laboratory abnormalities that
would place the subject at unacceptable risk for study participation.
- Currently pregnant or breastfeeding women.
- Currently participating in a clinical study, and receiving an investigational drug or
has participated in a therapeutic clinical trial within 4 weeks prior to