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Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

ConditionDuctal Carcinoma in Situ
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFinn, Olivera, PhD

About this trial

Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females, 18 years of age or older. Pre-menopausal women must use an effective method of contraception during the study.

Capable of providing informed consent and willing to comply with study procedures

Biopsy-proven ER+ DCIS

The signed pathology report from the attending pathologist will be used to determine eligibility

Disqualifiers

Invasive breast cancer > 1mm on pathologic evaluation

Second malignancy within the last 5 years (definitively treated superficial non-melanoma skin cancer, melanoma in situ, cervical carcinoma in situ allowed)

Current hormone replacement therapy, selective estrogen receptor modulator therapy, or aromatase inhibitor therapy--if yes, wash out of 30 days must occur prior to baseline biopsy for the study

Recurrent ipsilateral DCIS

Trial design

Design model

Parallel

Treatments tested in this trial

  • MUC1 Peptide Vaccine

    Biological/Vaccine

    MUC1, a therapeutic vaccine, is a transmembrane glycoprotein and a member of the mucin family of molecules.

  • Hiltonol®

    Drug

    A synthetic dsRNA viral mimic and host-defense activator, mimics nature by combining the essential elements of human immunity.

  • Aromatase Inhibitor

    Drug

    A type of hormone therapy for cancer used to inhibit aromatase to treat a hormone-related breast cancer.

  • Selective estrogen receptor modulator (SERM)

    Drug

    A type of hormone therapy that blocks cancer cells from being able to use estrogen to grow. prescribed for hormone receptor-positive breast cancer.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MUC1 vaccine + adjuvant Hiltonol + Aromatase Inhibitor or SERMExperimental treatment 4 interventions
Group B: Aromatase Inhibitor or SERMActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Immunogenicity (of MUC1 vaccine)

Percentage of patients with a 2-fold or greater increase in serum anti-MUC1 IgG from screening date. Serum IgG is measured using enzyme-linked immunosorbent assay (ELISA).

Time frame
At Week 12

Secondary outcomes

1

Adverse Events and Serious Adverse Events Related to Treatment

Number of AEs and SAEs related to study treatment using Common Terminology Criteria for Adverse Events version 5 (CTCAE v.5).

Time frame
Up to 2 years
2

Feasibility (Time to planned surgery)

Percentage of patients who experience a greater than 4-week variation in the time to planned surgery that is related to study participation.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Finn, Olivera, PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

A Glimmer of Hope Foundation

Collaborator

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov
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