What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those that stimulate the immune response like the alpha-lactalbumin vaccine, include immunotherapy and vaccines. Known side effects of these treatments can include fatigue, fever, chills, nausea, headache, and injection site reactions such as pain, redness, and swelling. More serious side effects may involve immune-related adverse events affecting organs such as the lungs, liver, endocrine glands, and skin, leading to conditions like pneumonitis, hepatitis, thyroiditis, and dermatitis. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for breast cancer, focusing on stimulating the immune system to target cancer cells. One notable approval is for pembrolizumab (Keytruda), an immune checkpoint inhibitor used in combination with chemotherapy for triple-negative breast cancer (TNBC). This treatment works by blocking the PD-1/PD-L1 pathway, thereby enhancing the immune response against cancer cells. While specific vaccines like the alpha-lactalbumin vaccine are still under investigation, the approval of pembrolizumab highlights the FDA's recognition of immunotherapy as a viable treatment option for breast cancer.

What other types of research exist?

Promising novel alternatives to the Alpha-lactalbumin vaccine for breast cancer patients in 2024 include: 1) Pembrolizumab (Keytruda) - an immune checkpoint inhibitor that has shown efficacy in various subtypes of breast cancer, including triple-negative breast cancer. 2) Trastuzumab deruxtecan (Enhertu) - an antibody-drug conjugate targeting HER2-positive breast cancer. 3) Sacituzumab govitecan (Trodelvy) - an antibody-drug conjugate for triple-negative breast cancer. 4) PARP inhibitors (e.g., Olaparib, Talazoparib) - particularly effective in patients with BRCA mutations. 5) CDK4/6 inhibitors (e.g., Palbociclib, Ribociclib) - used in combination with hormone therapy for HR-positive, HER2-negative breast cancer.

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Vaccine for Breast Cancer

Q: What is the mechanism of action of this treatment?

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Immunotherapy, such as the alpha-lactalbumin vaccine, stimulates the immune system to recognize and attack cancer cells expressing the alpha-lactalbumin protein, which is particularly relevant for triple-negative breast cancer patients. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer. Targeted therapy focuses on specific molecular targets, such as HER2, to inhibit cancer cell growth and survival. These treatments are crucial as they offer multiple strategies to combat breast cancer, improving patient outcomes and survival rates.

Phase < 1

Recruiting

Led By George T Budd, MD

Research Sponsored by George T. Budd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Histologically proven invasive breast cancer.

Must not have

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.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine to help the immune system fight breast cancer in patients who are at high risk or have already been treated for triple-negative breast cancer. The vaccine works by teaching the body's defense system to recognize and attack cancer cells.

Who is the study for?

This trial is for adults with non-metastatic triple-negative breast cancer who have completed initial treatment within the last 36 months, or those at high risk of developing such cancer. Participants must not be pregnant, breastfeeding, or using hormonal contraception and should have no recent history of chemotherapy or radiation therapy. They need normal organ function and cannot be on immunosuppressants.

What is being tested?

The study tests the safety and optimal dose of an alpha-lactalbumin vaccine in treating patients free from metastatic triple-negative breast cancer but at risk for recurrence, as well as preventing it in high-risk individuals. It also includes participants receiving adjuvant pembrolizumab after initial treatment.

What are the potential side effects?

Potential side effects are not detailed in the provided information; however, common reactions to vaccines may include soreness at injection site, fever, fatigue, headache and allergic reactions. Specific side effects will depend on individual patient responses to the alpha-lactalbumin vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood tests show my organs are functioning well.

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My breast cancer diagnosis was confirmed through a biopsy.

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My scans show no signs of cancer coming back.

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My breast cancer is considered high risk based on its stage or because cancer remains after chemotherapy.

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My breast cancer is at an advanced stage but not the most severe, or I still have cancer after chemotherapy.

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My breast cancer is triple-negative according to the latest guidelines.

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I am 18 years old or older.

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My blood and organ tests are within normal ranges.

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My breast cancer is triple-negative.

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I am fully active or can carry out light work.

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I am 18 years old or older.

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I am older than 18 years.

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I carry a harmful BRCA1 or PALB2 mutation, increasing my risk for triple-negative breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses that would stop me from following the study's requirements.

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I don't need corticosteroids beyond a low-dose replacement.

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I need medication to suppress my immune system due to an organ transplant.

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I am taking medication that can increase my prolactin levels.

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I am not using and do not plan to use oral contraceptives or hormone-containing IUDs.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am taking medication that can increase my prolactin levels.

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I am HIV positive.

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I have recovered from past cancer treatment side effects, except for hair loss and mild nerve pain.

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My cancer has spread or come back.

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I have not had another invasive cancer in the last 5 years.

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I have not had radiation therapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pembrolizumab Cohort of α-lactalbumin vaccine

Preventative Cohort MTD of α-lactalbumin vaccine

Treatment Cohort MTD of α-lactalbumin vaccine

Secondary study objectives

Pembrolizuman Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine

Preventative Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine

Treatment Cohort Lowest Immunologic Dose (LID) of α-lactalbumin vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment α-lactalbumin and zymosanExperimental Treatment2 Interventions

Participants diagnosed with triple negative breast cancer will be treated with successively higher doses of α-lactalbumin and zymosan in a 3 + 3 trial design. Treatment will involve 3 vaccinations every 2 weeks. Participants will be enrolled into 1 of 5 different dose levels each comprised of cohorts of 1-6 participants until the MTD has been identified (intra-patient dose escalation not permitted), after which the MTD will be expanded to 6 participants. Successively lower doses will be expanded to 6 participants until the lowest DL associated with immune response has been expanded. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic)

Group II: Standard of Care with a-lactalbumin and zymosanExperimental Treatment2 Interventions

Participants undergoing chemo-immunotherapy for operable triple-negative breast cancer will be treated with α-lactalbumin concurrently with standard of care adjuvant pembrolizumab after having completed all pre- and postoperative chemotherapy and radiation therapy, with the exception of Xeloda/capecitabine at provider discretion. Treatment will involve 3 vaccinations every 2 weeks. Participants enrolled in the Pembrolizumab cohort will be enrolled at the proper Optimal Immunologic Dose as defined by the TNBC and preventative cohorts and based on information available at the time of study entry. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic)

Group III: Preventitive a-lactalbumin and zymosanExperimental Treatment2 Interventions

Participants with a genetic risk for developing TNBC who plan to undergo prophylactic mastectomy will be treated with α-lactalbumin and zymosan at doses based on the TNBC cohort. Treatment will involve 3 vaccinations every 2 weeks. Participants enrolled in the prevention cohort will be enrolled at the dose level being used in the TNBC cohort if no DLTs above Grade 1 have been observed. If the TNBC cohort proceeds to the next dose level before another prevention cohort patient is enrolled, the next prevention patient will be enrolled on the next dose level along with the TNBC cohort. DL1: 10 mcg a-lactalbumin + 10 mcg Zymosan Original DL2:100 mcg a-lactalbumin + 100 mcg Zyomsan DL2: 100 mcg a-lactalbumin + 10 mcg Zyomsan DL3: 500 mcg a-lactalbumin + 10 mcg Zymosan DL1b: 50 mcg a-lactalbumin + 10 mcg Zymosan DL1e: 10 mcg a-lactalbumin + 20 mcg Zymosan DL1f: 20 mcg a-lactalbumin + 10 mcg Zymosan DL1g: 20 mcg a-lactalbumin + 10 mcg Zymosan (if DL1e is too toxic)

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and destroy cancer cells. Immunotherapy, such as the alpha-lactalbumin vaccine, stimulates the immune system to recognize and attack cancer cells expressing the alpha-lactalbumin protein, which is particularly relevant for triple-negative breast cancer patients. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that can promote the growth of hormone receptor-positive breast cancer. Targeted therapy focuses on specific molecular targets, such as HER2, to inhibit cancer cell growth and survival. These treatments are crucial as they offer multiple strategies to combat breast cancer, improving patient outcomes and survival rates.