What side effects are associated with this type of intervention?

Common treatments for estrogen receptor-positive breast cancer, such as peptide vaccines, tamoxifen, aromatase inhibitors, and immunotherapies, have various side effects. Peptide vaccines combined with adjuvants and GM-CSF may cause mild to moderate immune reactions like chills, fever, and fatigue. Tamoxifen can lead to hot flashes, increased risk of blood clots, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks. Immunotherapies, such as PD-1 inhibitors, may cause immune-related adverse events including rash, diarrhea, and pneumonitis.

What prior FDA approvals exist?

The FDA has approved several treatments for estrogen receptor-positive breast cancer that stimulate the immune response or target specific pathways. Notably, drugs like trastuzumab (Herceptin) and pertuzumab (Perjeta) target the HER2 receptor, which can be overexpressed in some breast cancers. Additionally, CDK4/6 inhibitors such as palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) have been approved for hormone receptor-positive, HER2-negative breast cancer. These treatments, while not peptide vaccines, represent significant advancements in targeting specific mechanisms within breast cancer cells to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to peptide vaccines for estrogen receptor-positive breast cancer patients include: 1) CDK4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib) which target cell cycle regulation, 2) PI3K inhibitors (e.g., alpelisib) for patients with PIK3CA mutations, 3) PARP inhibitors (e.g., olaparib, talazoparib) for patients with BRCA mutations, and 4) Immune checkpoint inhibitors (e.g., pembrolizumab) in combination with other therapies for enhanced immune response. These therapies offer targeted mechanisms of action and have shown efficacy in clinical trials.

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Cancer Vaccine

Peptide Vaccine for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Herbert Lyerly

Eligibility Criteria Checklist

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

Must have

Patients with histologically confirmed, resected, breast cancer with pT3 or greater T stage with any N stage and M0 pTxN+M0 (i.e., N1,2 or 3)

Patients with histologically confirmed, resected, breast cancer with HLA A0201+ and tumor is ER+

Must not have

Presence of an active acute or chronic infection including: urinary tract infection, HIV, or viral hepatitis

Splenectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new vaccine made from small pieces of breast cancer proteins, combined with substances that boost the immune system. It targets patients with estrogen receptor positive breast cancer who do not respond well to hormone treatments. The goal is to see if this vaccine is safe and if it can help the immune system fight the cancer more effectively.

Who is the study for?

This trial is for adults over 18 with a specific type of breast cancer that's been surgically removed but hasn't spread far. They should have finished any standard treatments like chemo at least 4 weeks ago and can't be more than 5 years out from those treatments. Their cancer must be estrogen receptor positive, they need to have certain immune system markers (HLA A0201+), and their organs must function well.

What is being tested?

The study tests a new vaccine made from cancer peptides targeting the estrogen receptor, combined with GM-CSF and Montanide ISA adjuvant to boost immune response. It aims to check safety first, then how well it triggers an immune reaction in patients who've resisted hormone therapy.

What are the potential side effects?

Potential side effects aren't detailed here, but as this is an early-phase trial focusing on safety, common reactions may include redness or pain at the injection site, flu-like symptoms such as fever or fatigue, and possibly allergic reactions to vaccine components.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer was surgically removed, was large or spread to lymph nodes, but not to other parts of my body.

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My breast cancer was surgically removed, is ER positive, and I have the HLA A0201+ gene.

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I am 18 years old or older.

Exclusion Criteria

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

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I currently have an infection such as a UTI, HIV, or hepatitis.

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I have had my spleen removed.

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My cancer has spread to distant parts of my body.

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I do not have skin conditions that would affect injections or skin reaction assessments.

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I am not currently undergoing chemotherapy, radiation, or immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Adverse Events

Secondary study objectives

detection of ESR mutant-specific memory T cells against at least one of the 5 immunizing peptides by Cytof analysis

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ESR1 peptide vaccineExperimental Treatment1 Intervention

200 mcg ESR1 peptides plus 1ml Montanide and 100 mcg GM-CSF administered subcutaneously weeks 0, 1, 2, 4, 5, 6 for a total of 6 injections.

0 / 8Eligibility 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

Common treatments for breast cancer, particularly estrogen receptor-positive types, include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies, such as tamoxifen and aromatase inhibitors, work by blocking estrogen receptors or reducing estrogen production, thereby slowing the growth of hormone-sensitive tumors. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, like HER2 inhibitors, specifically target and inhibit the function of proteins that promote cancer cell growth. Immunotherapy, including peptide vaccines, aims to stimulate the patient's immune system to recognize and attack cancer cells. These treatments are crucial as they offer multiple strategies to combat cancer, potentially improving survival rates and quality of life for breast cancer patients.

A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.Clinical Development of the E75 Vaccine in Breast Cancer.