Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment (PRESENT)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 709

Inclusion Criteria

Qual 1
1. Women, at least 18 years of age
2. Pathological diagnosis of invasive breast adenocarcinoma
3. Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery.
4. One of:
-Total mastectomy and axillary staging with sentinel lymph node dissection or axillary dissection level I/II. Patients with a +ve sentinel lymph node must have undergone completion axillary dissection level I/II.
-BCS (lumpectomy) and axillary staging with sentinel lymph node dissection or axillary dissection level I/II. Patients with a +ve sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes.
5. Node-positive disease defined as:
-Clinically node +ve disease in patients who present with a suspicious lymph node on physical examination or identified by radiologic imaging that is confirmed histologically by core biopsy or cytologically by fine needle aspiration biopsy. These patients will qualify even if final
pathological assessment of their lymph nodes is -ve (pN0) following neoadjuvant chemotherapy.
- Pathologic pN1 (including pN1mi) or pN2 disease for patients undergoing surgery as initial intervention.
6. Primary tumor stage T1-3 at time of initial breast cancer diagnosis.
Ipsilateral nodes must be N0-1 by clinical evaluation and pN1 M0 or pN2
M0
7. HER2 Tumor tissue status to be confirmed in a Central Lab using IHC
tests Bond™ Oracle™ HER2 IHC System III, Leica Biosystems) or the
same FISH test (PathVysion™ HER2 DNA Probe Kit, Abbott Diagnostics):
•HER2 expression levels as 1+ or 2+ determined by IHC via Bond™
Oracle™ HER2 IHC System III (Leica Biosystems)
•HER2 IHC 2+ intensity gene amplification confirmed by Abbott FISH
PathVysion HER2 DNA Probe Kit determining the HER2 gene count and
HER2 gene/ CEP17 ratio of 2. 0 or less (according to FISH PathVysion
Package Insert).
8. Hormone receptor (ER/PR) status determined by qualified laboratory.
9.Must complete approved regimen of neoadjuvant or adjuvant chemotherapy, or both, consisting of at least 4 cycles before receiving
study treatment (and subjects must have recovered (toxicity recovered
to = Grade 1) from effect of recent surgery, radiotherapy, or adjuvant
chemotherapy as determined by the principal investigator).
10. No more than 12 weeks and no sooner than 1 month from completion
of last SOC therapy, (surgery, adjuvant chemo- or radiotherapy), at time of first study treatment and with no evidence of disease (NED)
11.Must complete approved radiation therapy for subjects with total mastectomy prior to receiving study treatment:
•1-3 +ve axillary nodes – irradiation to chest wall, infraclavicular and
supraclavicular areas and internal mammary nodes not mandatory (may
be administered at discretion of the treating radiation oncologist).
•= 4 <10 +ve axillary nodes – chest wall irradiation and irridiation to infraclavicular and supraclavicular area mandatory; Irradiation to axillary area and internal mammary nodes not mandatory.
12.Must complete approved radiation therapy for subjects with BCS prior
to receiving study treatment: Adjuvant breast radiation indicated for all subjects treated with breast conservation (whole breast irradiation with/without boost dose of radiation to tumor bed):
•1 to 3 +ve axillary nodes: irradiation to the supraclavicular area, axillary area or internal mammary nodes not mandatory.
•= 4 <

Exclusion Criteria

1. Under 18 years of age.
2. Bilateral breast malignancy.
3. Inflammatory breast cancer.
4. Unconfirmed, nonmalignant but suspicious mass in opposite breast.
5. Primary tumor stage T4.
6. Nodes: clinical N2 or N3 or pathologic /cytologic N3.
7. History of prior breast cancer.
8. History of prior ductal carcinoma in situ (DCIS). Prior lobular carcinoma in situ (LCIS) is allowed.
9. Prior trastuzumab therapy.
10. Ongoing endocrine therapy except for adjuvant hormone therapy for breast cancer; tamoxifen and aromatase inhibitors (i.e., anastrozole, exemestane and letrozole) or LHRH agonists (i.e., goselerlin, leuprolide).
11. New York Heart Association Stage 3 or 4 cardiac disease
12. Pregnant, plan to become pregnant during study treatment duration or breastfeeding.
13. Sensory/motor neuropathy = Grade 2.
14. Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, type 1 diabetes mellitus or any other autoimmune disease that, in the opinion of the investigator, would compromise the subject's safety.
15. Immune deficiency diseases such as immunoglobulin deficiency or immunosuppressive therapy that might interfere with appropriate immune response
16. Positive test for human immunodeficiency virus (HIV), or hepatitis BsAg or hepatitis C
17. Patients on chronic steroid therapy or other immunosuppressive therapy except for topical steroids.
18. Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g. mannitol).
19. Concurrent treatment with other investigational agent.
20. Nonbreast malignancy within 5 years before randomization, except cured superficial recurrent bladder cancer, carcinoma in situ of the cervix (Stage 0 – 1), and basal cell or squamous cell carcinoma of the
skin.
21. Nonmalignant systemic disease that, in the opinion of the investigator, should preclude the subject's participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials