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Trial Title:
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
NCT ID:
NCT05504707
Condition:
Triple Negative Breast Cancer
HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HER2 - primed Dendritic cells
Description:
Dendritic cell will be administered at ultra-sound guided injections. Participants will
receive 8 intratumoral injections. These injections will be administered twice per week
per week (given 3 days apart). Participants will receive alternating injections (3 days
apart) of HER2-primed followed by HER3-primed DCs.
Participants will be treated at the following dose levels:
Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 -
primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells
dose 80-100 million
Arm group label:
Dendritic Cell Vaccine dose Escalation
Intervention type:
Biological
Intervention name:
HER3 - primed Dendritic cells
Description:
Dendritic cell will be administered at ultra-sound guided injections. Participants will
receive 8 intratumoral injections. These injections will be administered twice per week
per week (given 3 days apart). Participants will receive alternating injections (3 days
apart) of HER2-primed followed by HER3-primed DCs.
Participants will be treated at the following dose levels:
Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 -
primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells
dose 80-100 million
Arm group label:
Dendritic Cell Vaccine dose Escalation
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Childress
Email:
Jennifer.Childress@moffitt.org
Investigator:
Last name:
Ricardo Costa, MD, MSc
Email:
Principal Investigator
Investigator:
Last name:
Brian Czerniecki, MD, PhD
Email:
Sub-Investigator
Start date:
August 26, 2022
Completion date:
October 2025
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
The Shulas' Foundation
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504707
https://moffitt.org/clinical-trials-research/clinical-trials/?gclid=EAIaIQobChMImIymzIa-9gIVAZ2GCh3uzAWJEAAYASAAEgI0ovD_BwE