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

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Aug 15, 2022

Keywords

ClinConnect Summary

The DecipHER Trial is a study designed to see if an experimental vaccine called the Dendritic Cell (DC) vaccine, when combined with standard chemotherapy, can help patients with early-stage Triple Negative Breast Cancer (TNBC) and hormone receptor (HR) low positive breast cancer. This trial is currently looking for participants aged 18 and older who have been diagnosed with HER2-negative breast cancer and meet specific health criteria. To participate, individuals need to be in good overall health, have manageable organ function, and be able to commit to the treatment schedule.

If you or a loved one qualify and decide to join the trial, you will receive the DC vaccine along with standard chemotherapy treatments. This study aims to understand if the vaccine can improve treatment outcomes for patients with these types of breast cancer. It is important to note that participants will need to meet certain health standards, such as having normal blood counts and not being pregnant or nursing. The trial aims to provide valuable insights into new treatment options, and participants will be closely monitored throughout the study to ensure their safety and wellbeing.

Gender

ALL

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.