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)
概览
- 阶段
- 1 期
- 干预措施
- HER2 - primed Dendritic cells
- 疾病 / 适应症
- Triple Negative Breast Cancer
- 发起方
- H. Lee Moffitt Cancer Center and Research Institute
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
Dendritic Cell Vaccine dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.
干预措施: HER2 - primed Dendritic cells
Dendritic Cell Vaccine dose Escalation
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.
干预措施: HER3 - primed Dendritic cells
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 4 weeks after start of treatment
Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which \< 2 of 6 patients experience dose-limiting toxicities (DLTs).
次要结局
- Participants with clinical and radiological responses after receiving HER2/HER3 DC1(Up to 36 Months)
- Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1(Up to 36 Months)
- Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections(Up to 24 weeks)
- Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1(Up to 36 Months)
- Number of Dose Limiting Toxicities(5 weeks after start of treatment)
- Participants with Recurrence Free Survival (RFS)(Up to 36 Months)
- Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1(Up to 36 Months)