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Cancer Vaccine

Dendritic Cell Vaccine for Breast Cancer

Q: Are there still openings for participants in this research endeavor?

<p>This clinical trial is still open to participation, as indicated by the data hosted on clinicaltrials.gov. The investigation was initially made accessible on April 6th 2018 and has been modified up until August 23rd 2022.</p>

Q: What is the volume of participants being admitted to this investigation?

<p>Yes, according to clinicaltrials.gov, this trial is currently recruiting patients and will continue doing so until August 23rd 2022. It was initially posted on April 6th 2018 and the goal is to acquire 32 participants at a single site.</p>

Phase < 1

Waitlist Available

Led By Haten Soliman, M.D.

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

Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years post-surgery

Awards & highlights

Study Summary

This trial will test whether the DC1 study vaccine can help the participant's immune system make antibodies and T cells (a type of white blood cell) that will react to and kill HER2-positive breast cancer cells.

Who is the study for?

This trial is for adults with stage II or III HER2+ invasive breast cancer, who are in good health otherwise, with normal organ and marrow function. They must not be pregnant or breastfeeding, have no severe illnesses that could affect study participation, and agree to use contraception. It's not for those with inflammatory breast cancer, uncontrolled diseases like heart failure or arrhythmias, immune deficiencies, certain allergies to vaccine components or chemotherapy drugs.Check my eligibility

What is being tested?

The trial tests a new type of treatment called DC1 dendritic cell vaccine alongside standard neoadjuvant chemotherapy (TCH-P regimen) before surgery. The DC1 vaccine is made from the patient's own blood cells and aims to boost the immune system to fight breast cancer more effectively.See study design

What are the potential side effects?

Potential side effects include typical reactions related to vaccines such as pain at injection site, fever and fatigue; plus those associated with chemotherapy like nausea, hair loss, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My doctor agrees I can have specific chemotherapy and follow-up care.

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I am 18 years old or older.

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My breast cancer is at stage II or III, ERPR-negative, and HER2-positive.

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I am mostly self-sufficient and can carry out daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Expansion Phase Schedule Selection by Week 4

Pathologic Complete Response (pCR) Rate

Secondary outcome measures

Recurrence Free Survival (RFS)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Expansion PhaseExperimental Treatment3 Interventions

DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).

Group II: Lead In Phase - Arm AActive Control3 Interventions

Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.

Group III: Lead In Phase - Arm BActive Control3 Interventions

Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neoadjuvant Chemotherapy

2014

Completed Phase 2

~340

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,461 Total Patients Enrolled

40 Trials studying Breast Cancer

5,749 Patients Enrolled for Breast Cancer

United States Department of DefenseFED

861 Previous Clinical Trials

227,163 Total Patients Enrolled

36 Trials studying Breast Cancer

3,435 Patients Enrolled for Breast Cancer

Haten Soliman, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

DC1 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03387553 — Phase < 1

Breast Cancer Research Study Groups: Lead In Phase - Arm A, Lead In Phase - Arm B, Expansion Phase

Breast Cancer Clinical Trial 2023: DC1 Highlights & Side Effects. Trial Name: NCT03387553 — Phase < 1

DC1 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03387553 — Phase < 1

Frequently Asked Questions

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

Are there still openings for participants in this research endeavor?

"This clinical trial is still open to participation, as indicated by the data hosted on clinicaltrials.gov. The investigation was initially made accessible on April 6th 2018 and has been modified up until August 23rd 2022."

Answered by AI

What is the volume of participants being admitted to this investigation?

"Yes, according to clinicaltrials.gov, this trial is currently recruiting patients and will continue doing so until August 23rd 2022. It was initially posted on April 6th 2018 and the goal is to acquire 32 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

2018. "HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03387553.

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