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Criteria for Qualification for Breast Cancer Clinical Trial 

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

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No





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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