← Back to Search

Anti-microtubule agent

HER2 DC1 Vaccine + Chemotherapy for Breast Cancer

Phase 2

Recruiting

Led By Hyo (Heather) Han, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Participants must have normal organ and marrow function as defined per protocol

Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests

Must not have

Participants with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed

Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new vaccine to see if it can help people with a specific type of breast cancer.

Who is the study for?

This trial is for adults with stage I-III HER2+ breast cancer, measurable by exam or imaging. They must be fit for neoadjuvant chemo and surgery, have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a normal heart ejection fraction. Excluded are those on other trials, with inflammatory/unresectable/metastatic breast cancer, allergies to similar drugs/vaccine components, immune deficiencies requiring suppressants, unable to undergo apheresis or with uncontrolled illnesses.

What is being tested?

The study tests if adding a Dendritic Cell (DC1) vaccine to standard pre-surgery therapy (Paclitaxel/Trastuzumab/Pertuzumab) benefits patients with HER2+ breast cancer. Participants will receive this combination before their main treatment which includes resection surgery.

What are the potential side effects?

Possible side effects include reactions at the vaccine injection site; common chemotherapy-related issues like nausea and hair loss; infusion reactions from Trastuzumab and Pertuzumab; potential impact on blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

Select...

My organs and bone marrow are functioning normally.

Select...

My breast cancer is stage I-III, HER2 positive, and the tumor is at least 1 cm big.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

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

Select...

My breast cancer cannot be surgically removed or has spread from where it started.

Select...

I have an immune deficiency or take drugs to suppress my immune system.

Select...

I am not allergic to the study vaccine or similar chemotherapy drugs.

Select...

I am willing and able to undergo apheresis for vaccine production.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Heart rate

Lead in Phase: Immunogenicity of each dose level

Secondary study objectives

Expansion Phase: Immunogenicity

Expansion Phase: Radiologic tumor response rate after 6 weeks

Expansion Phase: Radiologic tumor response rate at completion of therapy

+1 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Lead In: Dose Level 2Experimental Treatment5 Interventions

Six participants will be treated at dose level 2: DC vaccine given at the dose of 100 million once per week for 6 weeks

Group II: Lead In - Dose level 1Experimental Treatment5 Interventions

Six participants will be treated at dose level 1: DC vaccine given at the dose of 50 million once per week for 6 weeks

Group III: Expansion -Estrogen Receptor (ER) positiveExperimental Treatment5 Interventions

An additional 24 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).

Group IV: Expansion -Estrogen Receptor (ER) negativeExperimental Treatment5 Interventions

An additional 23 participants will be enrolled at dose level 2 if determined to be safe in lead in phase to have a total of 28 evaluable participants for pathologic response assessment (including 6 pts from the lead in phase).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

FDA approved

Pertuzumab

FDA approved

Paclitaxel

FDA approved

0 / 8Eligibility criteria met