Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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Important Patient Information and Schedule for participation:

Treatment will involve a course of 3 vaccinations given every 2 weeks and assessed every 2 weeks until day 56. They must be available to travel to the Cleveland Clinic in Cleveland Ohio for vaccine injection and evaluation.

 

Inclusion Criteria:

• Histologically proven invasive breast cancer.

• Primary tumor must be ER-negative (ER in <1% of cells), PR-negative (PR in <1% of cells), and HER2-negative (0-1+ by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH) ratio<2.0 with signal number <6/cell).

• Participants must be high-risk, defined as either:

  • Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by American Joint Committee on Cancer (AJCC) 8, or

  • Residual invasive cancer in breast or regional nodes following preoperative chemotherapy.

• Patients must have no convincing evidence of recurrent disease based on one of the following:

  • Bone scan and imaging scans of the chest/abdomen/pelvis or

  • 18F-2-fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) scan

• (≥)1 months since last active therapy (chemotherapy, radiation therapy, or surgery) and <36 months since the initiation of treatment for the current cancer, based on the period of highest risk for patients with Stages I-III triple-negative breast cancer

• Treatment prior to enrollment must be consistent with contemporary National Comprehensive Cancer Network (NCCN) guidelines

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• Adequate major organ function, defined as:

  • white blood cell (WBC) count > 3,000/mcl,

  • hemoglobin > 10.0 gm/dL,

  • platelets > 100,000/mcL,

  • total bilirubin within normal limits,

  • ALT/AST <3 x upper limits of normal (ULN),

  • serum creatinine < 1.5 x ULN

• Serum prolactin level must be < upper limits of normal (ULN);

• Participants must have the ability to understand and the willingness to sign and provide a written informed consent document;

• Participants must have archival tissue available for potential correlative studies (e.g., assays for α-lactalbumin expression or tumor infiltrating lymphocytes), but tumors will not be required to exhibit overexpression of α-lactalbumin for enrollment.

• Participants agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection

 

Exclusion Criteria:

• Receipt of cytotoxic chemotherapy within 4 weeks of study entry

• Radiation therapy within 4 weeks of study entry

• Failure to recover from the toxicity of the previous therapy to CTCAE Grade 0-1, except for alopecia and grade 2 neuropathy

• Need for systemic corticosteroid use (except as physiologic replacement, defined as prednisone 10 mg/day or equivalent).

• Need for immunosuppression (e.g., for a history of organ transplantation)

• Known HIV infection

• Active or planned lactation or pregnancy

• Patients taking or planning to take oral contraceptives will be excluded, as there is some evidence that such agents can induce lactational foci. This includes patients using hormone containing IUD's.

• Refusal to use effective non-hormonal contraception. Acceptable contraception methods include but may not be limited to barrier contraception (diaphragm or condom), non-hormonal intrauterine device, vasectomy of male partner

• Participants receiving any other investigational agents within the last 4 weeks.

• Participants with any known recurrence or metastasis

• Participants with a history of another active invasive malignancy within 5 years of study entry

• History of allergic reactions to α-lactalbumin, human milk (excluding lactose intolerance), Zymosan, or other agents used in this study

• Participants with 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

• Participants with known hyperprolactinemia

• Participants being treated with drugs known to cause hyperprolactinemia

• Known allergy to penicillin

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