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Status:

ACTIVE_NOT_RECRUITING

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer

Lead Sponsor:

George T. Budd

Collaborating Sponsors:

United States Department of Defense

Anixa Biosciences, Inc.

Conditions:

Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer

TNBC - Triple-Negative Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negati...

Detailed Description

This is an open-label, phase I dose-escalation trial that will be performed on three successive cohorts. The first cohort is comprised of participants with high-risk triple-negative breast cancer. The...

Eligibility Criteria

Inclusion

  • Triple Negative Cohort:
  • 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 IHC or FISH ratio\<2.0 with signal number \<6/cell), or consistent with contemporary NCCN guidelines (https://www.nccn.org/).
  • Patients must be high risk, defined as either:
  • Pathologic stage IIA, IIB, IIIA, IIIB, or IIIC by 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
  • FDG 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 triplenegative breast cancer \[33, 34\].
  • Treatment prior to enrollment must be consistent with NCCN guidelines extant at the time treatment was given, found at: https://www.nccn.org/.
  • Age greater than or equal to 18 years.
  • ECOG Performance Status 0-1.
  • Adequate major organ function, defined as:
  • WBC ≥ 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).
  • Subjects must have the ability to understand and the willingness to sign and provide a written informed consent document.
  • Subjects 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.
  • Subject agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection. ). Patients may be asked to complete a "wash out" period prior to the first dose of vaccine at the PI's discretion to ensure the absence of all alternative therapies.
  • Prevention Cohort:
  • Participant must have a high risk for developing triple-negative breast cancer, defined as: carrying a deleterious mutation in BRCA1, PALB2 or BRCA2
  • Patients must have no evidence of breast cancer based on both of the following: Negative mammography or breast MRI within 180 days, Negative breast examination by a physician or advanced practice practitioner within 30 days
  • Age ≥ 18 years
  • ECOG Performance Status 0-1.
  • Adequate major organ function, defined as: WBC ≥ 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)
  • Subjects must have the ability to understand and the willingness to sign and provide a written informed consent document.
  • Subject agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection. Patients may be asked to complete a "wash out" period prior to the first dose of vaccine at the PI's discretion to ensure the absence of all alternative therapies.
  • Pembrolizumab Cohort:
  • 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 IHC or FISH ratio \<2.0 with signal number \<6/cell), or consistent with contemporary NCCN guidelines (https://www.nccn.org/).
  • Patients must be high risk, defined as having residual invasive cancer in breast or regional nodes following pre-operative 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: FDG PET scan.
  • \>1 months since last active therapy with chemotherapy (excluding Xeloda/capecitabine), radiation therapy, or surgery and at least 6 weeks of pembrolizumab therapy planned after the first dose of alpha-lactalbumin vaccine.
  • Treatment prior to enrollment must be consistent with NCCN guidelines extant at the time treatment was given, found at: https://www.nccn.org/.
  • Age \>18 years.
  • ECOG Performance Status 0-1.
  • Adequate major organ function, defined as: WBC \> 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).
  • Subjects must have the ability to understand and the willingness to sign and provide a written informed consent document.
  • Subjects 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.
  • Subject agrees not to use alternative therapies from the time of informed consent through 30 days following the last vaccine injection. Patients may be asked to complete a "wash out" period prior to the first dose of vaccine at the PI's discretion to ensure the absence of all alternative therapies.

Exclusion

  • Triple Negative Cohort:
  • Receipt of cytotoxic chemotherapy within 4 weeks of study entry (except for capecitabine in subjects enrolled in the pembrolizumab cohort).
  • 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.
  • Subjects receiving any other investigational agents within the last 4 weeks.
  • Subjects with any known recurrence or metastasis.
  • Subjects 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.
  • Subjects 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.
  • Subjects with known hyperprolactinemia.
  • Subjects being treated with drugs known to cause hyperprolactinemia
  • Subjects diagnosed with TNBC while pregnant.
  • Subjects having lactated within 6 months of study start (first dose of vaccine).
  • Prevention Cohort:
  • Receipt of cytotoxic chemotherapy within 4 weeks of study entry (including for benign indications).
  • Radiation therapy within 4 weeks of study entry (including for benign indications)
  • 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.
  • Subjects receiving any other investigational agents within the last 4 weeks.
  • Subjects with a history of 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.
  • Subjects 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
  • Subjects with known hyperprolactinemia
  • Subjects being treated with drugs known to cause hyperprolactinemia
  • Subjects having lactated within 6 months of study start (first dose of vaccine).
  • Pembrolizumab Cohort:
  • All exclusion criteria for the pembrolizumab cohort will be the same as the TNBC cohort as outlined above, with the exception of: Failure to recover from the toxicity of the previous therapy to CTCAE Grade 0-1, except for:
  • Alopecia
  • Grade 2 neuropathy, or,
  • Grade 2 or 3 decreased lymphocyte count/lymphopenia (only in the pembrolizumab cohort in patients having received radiation therapy within 6 months of study enrollment)

Key Trial Info

Start Date :

October 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2026

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT04674306

Start Date

October 1 2021

End Date

May 1 2026

Last Update

May 23 2025

Active Locations (1)

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Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44915