Gender
Female
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Age >= 18 years
- Female
- Resected unilateral or bilateral primary carcinoma of the breast without clinical
evidence of metastatic disease (after neoadjuvant chemotherapy and/or adjuvant
chemotherapy), negative for estrogen receptor (ER) and progesterone receptor (PR)
(cut-off for positivity is > 10% positive tumor cells with nuclear staining), and
negative for HER2 as defined by one of the four situations delineated below:
- HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization
non-amplified
- HER2 IHC expression of 0 or 1+ and in-situ hybridization not done
- HER2 IHC expression of 2+ and in-situ hybridization non-amplified
- IHC not done and in-situ hybridization non-amplified
- Note: central review is not required
- Note: If biopsy and surgical specimens are discordant from each other with
regard to ER, PR, and/or HER2 status, a patient will be allowed to enroll
assuming at least one of the specimens meets the above criteria and no
endocrine therapy use is planned going forward
- Completed planned breast CANCER surgeries, any radiation therapy, and any
chemotherapy, whichever is last, >= 90 days but not >= 546 days prior to
randomization
- Note: Reconstructive and prophylactic surgeries are allowed after randomization
(during study treatment)
- Patient had at least one of the following:
- Biopsy or surgery-proven regional node involvement by cancer
- T1c, T2, T3, or T4 disease (with inflammatory disease allowed) identified at
the time of surgery or clinically identified prior to neoadjuvant chemotherapy
- No complete response to neoadjuvant chemotherapy (those who did achieve
complete response are still eligible if a pre-chemotherapy regional nodal
biopsy identified cancer or if the pre-chemotherapy tumor measured > 1 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1
- Absolute neutrophil count (ANC) >= 1500/mm^3 obtained =< 14 days prior to
randomization
- Platelet count >= 75,000/uL obtained =< 14 days prior to randomization
- Aspartate transaminase (AST) =< 3 x upper limit of normal (ULN) obtained =< 14 days
prior to randomization
- Creatinine =< 1.5 x ULN obtained =< 14 days prior to randomization
- Negative serum pregnancy test done =< 14 days prior to randomization, for women of
childbearing potential only
- Provide informed written consent
- Willing to return to enrolling institution for follow-up
- Willing to provide tissue and blood samples for correlative research studies
Exclusion Criteria:
- Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate
contraception
- Clinical evidence of local recurrence or distant metastases; Note: New primary
tumors are allowed, both contralaterally and ipsilaterally, but a prior breast
cancer must have been more than 5 years beforehand
- Known hypersensitivity reaction to GM-CSF
- Active autoimmune disease that has required systemic treatment =< 30 days (i.e.,
with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
prior to randomization; Note: replacement therapy (e.g., thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment; patients with
vitiligo, Graves disease, or psoriasis not requiring systemic treatment within the
past 30 days are not excluded; patients with Celiac disease controlled with diet
modification are not excluded
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
- NOTE: Localized fungal or viral infections including of the skin, nails, mouth,
and genital area are allowed
- History of other cancer < 5 years prior to consent (except non-melanoma skin cancer
or carcinoma in situ of the uterine cervix) or current receipt of treatment another
cancer (e.g., monoclonal antibody, small molecule pathway inhibitor)
- Treatment with systemic corticosteroid or immune-modulators =< 7 days prior to
randomization
- Concurrent treatment with other experimental drugs or any other systemic anticancer
therapy (due to unknown drug-vaccine potential interactions). Use of experimental or
other targeted therapy > 3 months prior is allowed as long as it is not
Her2-directed
- NOTE: Aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), statins, and
other medications commonly used to treat nononcologic, non-autoimmune
conditions are allowed
- Immunocompromised patients and patients known to be human immunodeficiency virus
(HIV) positive and currently receiving antiretroviral therapy
- Prior or concurrent use of trastuzumab or other Her2-directed therapy
- Prior or concurrent use of a PD-1 or PD-L1 checkpoint inhibitor (including
pembrolizumab) unless the use was >= 3 months prior to randomization