RECRUITING

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

Conditions

Triple Negative Breast Cancer HER2-negative Breast Cancer Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive breast cancer.

Official Title

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)

Quick Facts

Study Start:2022-08-26

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05504707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* A diagnosis of HER2-negative breast cancer. * Diagnosis of HR negative or HR low positive tumor. * Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer. * Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician. * Age ≥18 years. * ECOG performance status 0 or 1. * Patients must have normal organ and marrow function, as defined below, within 14 days of registration: * \Absolute neutrophil count (ANC) ≥ 1500/μL \Platelets ≥ 75 000/μL \Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL \AST/ALT ≤ 3 x institutional ULN \Creatinine ≤ 1.5 x institutional ULN Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan). * Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile. * Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.	* Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer. * Patients with inflammatory breast cancer. * Patients must not be receiving any other investigational agents or active antineoplastic therapies. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more). * Female patients who are pregnant or nursing. * No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease free for at least 3 years. * History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). * History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection. * Patients who have received a live attenuated vaccine ≤ 30 days prior to registration. * Unable to comply with the treatment schedule and study procedures for any reason. * Previously treated with breast cancer-directed vaccine therapies in prior 3 months. * Previously treated with any form HER2- or HER3-primed DC1 therapy.

Inclusion Criteria

Exclusion Criteria

* A diagnosis of HER2-negative breast cancer.
* Diagnosis of HR negative or HR low positive tumor.
* Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
* Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
* Age ≥18 years.
* ECOG performance status 0 or 1.
* Patients must have normal organ and marrow function, as defined below, within 14 days of registration:
* \*Absolute neutrophil count (ANC) ≥ 1500/μL
* \*Platelets ≥ 75 000/μL
* \*Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL
* \*AST/ALT ≤ 3 x institutional ULN
* \*Creatinine ≤ 1.5 x institutional ULN
* Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan).
* Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile.
* Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.

* Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
* Patients with inflammatory breast cancer.
* Patients must not be receiving any other investigational agents or active antineoplastic therapies.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).
* Female patients who are pregnant or nursing.
* No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease free for at least 3 years.
* History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
* History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection.
* Patients who have received a live attenuated vaccine ≤ 30 days prior to registration.
* Unable to comply with the treatment schedule and study procedures for any reason.
* Previously treated with breast cancer-directed vaccine therapies in prior 3 months.
* Previously treated with any form HER2- or HER3-primed DC1 therapy.

Contacts and Locations

Study Contact

Ricardo Costa

CONTACT

813-745-5051

Ricardo.Costa@moffitt.org

Principal Investigator

Ricardo Costa, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Ricardo Costa, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-26

Study Completion Date2026-10

Study Record Updates

Study Start Date2022-08-26

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

Breast Cancer

Additional Relevant MeSH Terms

Triple Negative Breast Cancer
HER2-negative Breast Cancer