Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Participants That Achieved Pathologic Complete Response (CR)
研究概览
简要总结
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
详细描述
Study Drugs:
Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR).
Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor.
Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow.
5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.
- •Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
- •>/= Age 18
- •ECOG performance status </= 1
- •Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL
- •Adequate cardiac function (LVEF >/= 45%)
- •Adequate Renal function: Creatinine (Cr) </= 1.5 mg/dL x ULN, Creatinine clearance (CrCl) >/= 50 mL/min calculated by the Cockcroft-Gault method as follows: Male creatinine clearance = (140 - age) x (weight in Kg) / (serum Cr x 72) Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
- •Adequate Hepatic function: Aspartate aminotransferase (AST) </= 2.5 x ULN • Alanine aminotransferase (ALT) </= 2.5 x ULN • Alkaline phosphatase (Alp) </= 2.5 x ULN.Total bilirubin </=1.5 x ULN
- •Ability and willingness to sign an informed consent form for this protocol
- •If female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.
- •Patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,
排除标准
- •History of radiation or chemotherapy
- •HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
- •Recurrent breast cancer
- •History of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
- •Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •History of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest CT scan
- •Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
- •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.
- •Peripheral neuropathy >= Gr II
研究组 & 干预措施
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: Panitumumab (Drug)
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: Nab-paclitaxel (Drug)
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: Carboplatin (Drug)
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: 5-Fluorouracil (Drug)
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: Epirubicin (Drug)
PNC + FEC
PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants That Achieved Pathologic Complete Response (CR)
时间窗: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
次要结局
- Number of Participants With Treatment-related Adverse Events (AEs)(Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.)