AE37 Peptide vaccine for Triple Negative Breast Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Stefanie Spielman Comprehensive Cancer Center, Columbus, OH
Triple Negative Breast Neoplasms+2 More
AE37 Peptide vaccine - Biological
Eligibility
18+
Female
Eligible conditions
Triple Negative Breast Neoplasms

Study Summary

Establishing the Recommended Biological Dose for AE37 Peptide Vaccine in Combination With Pembrolizumab That Will Enhance the Tumor-specific Immune Response and Demonstrate Efficacy in Patients With Advanced Triple-negative Breast Cancer

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Eligible Conditions

  • Triple Negative Breast Neoplasms
  • Breast Cancer
  • Triple-negative Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether AE37 Peptide vaccine will improve 2 primary outcomes and 4 secondary outcomes in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of Adverse events assessed from the beginning of study therapy through 90 days after the last dose of study therapy.

Day 90
Overall Toxicity
Day 21
Recommended dose
Day 21
Objective response rate
Day 21
Clinical benefit rate
Overall Survival
Progression-free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Arm 1

This trial requires 29 total participants across 2 different treatment groups

This trial involves 2 different treatments. AE37 Peptide Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 1AE37 peptide vaccine every 21 days for 5 doses + Pembrolizumab every 21 days for 2 years (Maximum 35 cycles)
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, within 72 hours of vaccination (48-72 hours), and as adverse events occur in each cycle (21 days) of study therapy (first 13 patients).
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1, within 72 hours of vaccination (48-72 hours), and as adverse events occur in each cycle (21 days) of study therapy (first 13 patients). for reporting.

Closest Location

Stefanie Spielman Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with treated, stable, asymptomatic metastatic disease to the brain that does not require chronic corticosteroids are eligible for the study (at the discretion of the treating investigator). show original
The primary or metastatic tissue must be negative for estrogen receptors (ER) and progesterone receptors (PR) (ER/PR less than or equal to 9%), as well as human epidermal growth factor receptor 2 (HER2) by American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines. show original
Within two weeks of treatment initiation, all screening labs should be performed in order to demonstrate adequate organ function. show original
A person's ANC is considered high if it is greater than or equal to 1,500/mm3. show original
A patient must have evidence of measurable metastatic breast cancer based on RECIST 1.1 in order to qualify for radiation therapy show original
At least one of the tumor sites must be accessible for a core needle biopsy. show original
Have a performance status of "Able to carry out all self-care activities" or "Able to carry out most self-care activities" on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. show original
In order to be eligible for treatment with trastuzumab, patients must have histologic or cytologic confirmation of the diagnosis of invasive adenocarcinoma of the breast. show original
The patient must have had a resolution of any toxic effects from the most recent chemotherapy to a level of Grade 1 or less (except for hair loss) show original
are associated with a higher incidence of thrombosis Platelets that are greater than or equal to 100,000/mm3 are more likely to cause blood clots. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is triple negative breast neoplasms?

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Triple negative breast carcinomas are a rare but challenging group of tumors, which are often aggressive and hard to manage, and may be associated with poor survival. A better understanding of the genetics and molecular bases of this subset of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s is required to make improvements in prevention, diagnosis, and treatment. Cancer 2013;121:721-6. © 2013 American Cancer Society.

Unverified Answer

How many people get triple negative breast neoplasms a year in the United States?

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TNBC incidence has increased significantly over the last 50 years; however, many of the contributing factors have not yet been determined. The age-standardized rates of TNBC remain relatively low in the US overall. These trends were more pronounced in African-American women. TNBC incidence rates appear to have significantly increased among young, black women, women from low-income and rural backgrounds, and those with BRCA mutations.

Unverified Answer

What causes triple negative breast neoplasms?

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It is proposed that the development of triple negative-type breast tumors is caused by the accumulation of several environmental, behavioral, genetic, and hormonal factors. The findings presented in this article show that there exists an association between tobacco consumption and triple negative-type breast cancer with a greater number of triple negative breast tumors occurring in the elderly.

Unverified Answer

What are the signs of triple negative breast neoplasms?

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TNBC is a diverse heterogenous group, with a range of clinical patterns. The most common type of TNBC is ER-, PR-, and HER2-, which may be the basis for the development of targeted therapies, that is, monoclonal antibodies and aromatase inhibitors. In rarer variants of TNBC, such as ALK-positive, ER-positive and/or PR-positive, it is important to be familiar with therapeutic options such as targeted therapies, taxanes, anthracyclines, and/or platinum-based chemotherapy. We propose a more explicit nomenclature for TNBC, as well as, a more complete clinical description of TNBC subtypes.

Unverified Answer

What are common treatments for triple negative breast neoplasms?

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For TNBC, the majority of treatment trials and meta-analyses were published before 2010. Most reviewed agents were in their first or second-line and only a minority of agents had clinical evidence suggesting improved disease progression, recurrence, or survival. Clinical trials are ongoing, especially trials addressing adjuvant therapies which could help prevent recurrence and treatment of metastatic breast cancer.

Unverified Answer

Can triple negative breast neoplasms be cured?

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In some TNBC patients, surgery followed by adjuvant chemotherapy and radiotherapy are sufficient to allow long-term disease-free survival, but the risks of long-term adverse treatment effects for these women might preclude complete surgical removal of TNBC. This fact should be taken into account when choosing management of TNBC patients.

Unverified Answer

What does ae37 peptide vaccine usually treat?

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Results from a recent clinical trial demonstrated that AE37 peptide vaccine could be used to treat breast tumor due to it can induce anti-tumor immune responses in C3H/He mice.

Unverified Answer

What is the survival rate for triple negative breast neoplasms?

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About 30% of women with [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) will develop distant metastases at some point while the disease is in a stage of localized growth. Approximately 4% of women will also develop distant metastases while the cancer remains localized. When triple negative breast cancer is metastatic, the survival rate is about 50%. Survival is dependent upon the type of metastase (bone or visceral) and the site of the metastasis. If the metastases are limited to the bones, the prognosis is favorable. If bone metastases only are present, about 55% of patients who develop metastases will have a favorable outcome. Women who develop distant metastases also have less favorable survival.

Unverified Answer

Does triple negative breast neoplasms run in families?

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Patients with triple negative breast neoplasms have a higher frequency of a family history. Although the underlying molecular and pathological cause of hereditary [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) still needs to be discovered, the findings of this study add clinical evidence that a family history of triple negative cancers should be investigated.

Unverified Answer

How serious can triple negative breast neoplasms be?

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The clinical features associated with [triple negative breast cancer](https://www.withpower.com/clinical-trials/triple-negative-breast-cancer) might be different to those of other cancers such as ductal carcinoma and lobular carcinoma. The management of patients with triple negative breast cancer should therefore be tailored to their specific features. Local recurrence-free survival is important in evaluating the efficacy of any treatment for triple negative breast cancer.

Unverified Answer

What is the latest research for triple negative breast neoplasms?

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The treatment approaches, like the neoadjuvant chemotherapy, have not been proven helpful in the management of TNBC. The latest knowledge suggests that adjuvant-only chemotherapy, including palliative chemotherapy and trastuzumab, has been proven feasible for TNBC. However, the benefit of neoadjuvant chemotherapy in TNBC remains to be proven.

Unverified Answer

What is ae37 peptide vaccine?

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Vaccination with ae37 peptide elicited potent humoral and cellular immune responses when used in combination with rEP-3 (a synthetic analog of the mammary-epithelial growth factor (mEGF)) as adjuvants in HER2-positive and triple-negative breast cancer patients. Furthermore, ae37 peptide vaccination with or without adjuvants was shown to prolong survival.

Unverified Answer
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