ALPHA CUT FREE TRIAL TRIAL

Known hypersensitivity reaction to GM-CSF.

Note: New primary tumors are allowed, both contralaterally and ipsilaterally, but a prior breast cancer must have been more than 5 years beforehand.

Clinical evidence of local recurrence or distant metastases.

Women of childbearing potential who are unwilling to employ adequate contraception.

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:.

Willing to provide tissue and blood samples for correlative research studies.

Willing to return to enrolling institution for follow-up.

Negative serum pregnancy test doneВ в‰¤ 14 days prior to randomization, for women of childbearing potential only.

CreatinineВ в‰¤ 1.5 x ULN obtainedВ в‰¤ 14 days prior to randomization.

Aspartate transaminase (AST)В в‰¤ 3 x upper limit of normal (ULN) obtainedВ в‰¤ 14 days prior to randomization.

Platelet countВ в‰Ґ 75,000/uL obtainedВ в‰¤ 14 days prior to randomization.

Absolute neutrophil count (ANC)В в‰Ґ 1500/mm^3 obtainedВ в‰¤ 14 days prior to randomization.

The following laboratory values obtained в‰¤14 days prior to randomization:.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.

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).

T1c, T2, T3, or T4 (disease with inflammatory disease allowed) identified at the time of surgery or clinically identified prior to neoadjuvant chemotherapy).

Biopsy or surgery-proven regional node involvement by cancer.

Patient had at least one of the following:.

Note: Reconstructive and prophylactic surgeries are allowed after randomization (during study treatment).

Completed planned breast CANCER surgeries,В any radiation therapy, and any chemotherapy, whichever is last, в‰Ґ 90 days but notВ в‰Ґ 546 days prior to randomization.

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.

IHC not done and in-situ hybridization non-amplified.

HER2 IHC expression of 2+ and in-situ hybridization non-amplified.

HER2 IHC expression of 0 or 1+ and in-situ hybridization not done.

HER2 immunohistochemistry (IHC) expression of 0 or 1+ and in-situ hybridization non-amplified.

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:.

NOTE: Waivers to eligibility criteria are not allowed per ACCRU policy. Contact the study team to discuss study eligibility and potential participation.

ALPHA CUT FREE TRIAL TRIAL

There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Guidelines differ from study to study, and identify who can or cannot participate. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Giving multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide may work better in treating patients with triple negative breast cancer. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. The purpose of this study is to evaluate how well multi-epitope folate receptor alpha peptide vaccine, sargramostim, and cyclophosphamide work in treating patients with triple negative breast cancer. Sponsor Protocol Number: RU011501I About this study

Alpha cut free trial