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Cancer Vaccine

MUC1 Vaccine + Aromatase Inhibitor for Breast Cancer

Phase 1

Recruiting

Led By Emilia Diego, MD

Research Sponsored by Finn, Olivera, PhD

Eligibility Criteria Checklist

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

Must have

Postmenopausal female, 18 years of age or older (no menstrual period for at least 12 months, or S/P oophorectomy)

Candidate for aromatase inhibitor

Must not have

Recurrent ipsilateral DCIS

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is enrolling post-menopausal women with a condition called DCIS. There are two groups in the trial. One group will receive a medication called an aromatase inhibitor for about

Who is the study for?

This trial is for post-menopausal women who have been diagnosed with a type of breast cancer known as Ductal Carcinoma In Situ (DCIS). The key eligibility criteria are not provided, but typically participants would need to meet certain health standards and agree to the treatment schedule.

What is being tested?

The study is testing two approaches in treating DCIS. One group will receive an aromatase inhibitor alone, while the other will get both an aromatase inhibitor and a new MUC1 peptide vaccine combined with Hiltonol® before surgery. There's also an optional booster shot of the vaccine six months after surgery.

What are the potential side effects?

While specific side effects are not listed, vaccines can cause reactions at the injection site, flu-like symptoms, and allergic responses. Aromatase inhibitors may lead to joint pain, hot flashes, and osteoporosis.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman over 18 and have not had a period for at least 12 months or have had my ovaries removed.

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I am eligible for aromatase inhibitor therapy.

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I am fully active or can carry out light work.

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My kidney function is within the normal range.

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My biopsy shows I have ER+ ductal carcinoma in situ.

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I have a tissue sample with DCIS available for research.

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I am scheduled for surgery as part of my main cancer treatment.

Exclusion Criteria

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

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My breast cancer has come back on the same side.

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I am currently on medication for an infection.

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I am currently on immunomodulator therapy.

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I have been diagnosed with HIV.

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My breast cancer is larger than 1mm.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at screening, week 2, week 4, week 6, week 10, week 12, week 16, week 20, up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Immunogenicity (of MUC1 vaccine)

Secondary study objectives

Adverse Events and Serious Adverse Events Related to Treatment

Feasibility (Time to planned surgery)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MUC1 vaccine + adjuvant Hiltonol + Aromatase InhibitorExperimental Treatment3 Interventions

MUC1 peptide vaccine with poly-ICLC adjuvant Hiltonol administered subcutaneously (SQ) Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily

Group II: Aromatase InhibitorActive Control1 Intervention

Anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg by mouth daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aromatase Inhibitor

2012

Completed Phase 4

~1690

0 / 13Eligibility criteria met