Gene Expression Assays and 68 Ga-Affibody HER-2 Imaging PET in Predicting Response to Treatment With Trastuzumab and Pertuzumab Before Surgery in Chinese Patients With HER2 Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response
研究概览
简要总结
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
详细描述
This study is to evaluate the correlation between early changes in multiple markers and pathological complete response in breast and lyphm nodes (tpCR) in patients with HER2-positive breast cancer receiving carboplatin, docetaxel and trastuzumab plus pertuzumab (TCHP) pre-operatively. The markers would be examined by gene expression assays, fluorodeoxyglucose positron emission tomography (18F-FDG-PET), 68 Ga-Affibody HER-2 Imaging PET, and organoid drug sensitivity test. Approximately 94 patients were treated with PH-based neoadjuvant therapy followed by surgery, and would complete 1 year of PH-based regimen in the adjuvant setting. The primary endpoint is the percent change of SUVmax from baseline to Day 15 (after the first cycle of anti HER-2 targeting drug treatment) on FDG PET and HER-2 imagining PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab and trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
- •Primary tumor greater than (>) 2 cm in diameter.
- •Age ≥ 18 years and < 70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=)
- •Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55%
- •Availability of tumor tissue specimen after surgery.
- •Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
- •Histologically proven diagnosis of breast cancer.
- •Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
- •Had hormonal receptors (ER and PgR) assessed.
- •Signed informed consent.
- •Able to comply with the protocol.
排除标准
- •Metastatic disease (Stage IV) or bilateral breast cancer.
- •Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
- •Prior breast or non-breast malignancy within 5 years prior to study entry.
- •Inadequate bone marrow, renal, or liver function
- •History or evidence of cardiovascular condition
- •Severe, uncontrolled systemic disease
- •Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
- •Pregnancy or breast-feeding women.
- •Participants who received any investigational treatment within 4 weeks of study start.
- •Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
- •Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids]).
- •Known hypersensitivity to any of the study drugs or excipients
结局指标
主要结局
Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response
时间窗: From baseline to day 15
Change in SUVmax from baseline to Day 15 on 18-FDG PET and 68Ga-Affibody HER-2 Imaging PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab.
次要结局
- Overall survival (OS)(Following surgery until Year 5)
- Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)(Immediately after the surgery)
- Invasive disease-free survival (iDFS) (excluding Second Primary Non-Breast Cancer [SPNBC])(Following surgery until Year 5)
- iDFS (including SPNBC)(Following surgery until Year 5)
研究者
Jiong Wu
Professor, Department of Breast Surgery Vice President, Cancer Hospital, Fudan University
Fudan University