2024-516205-23-00招募中2 期
Image-guided de-escalation of neoadjuvant chemotherapy in HER2-positive breast cancer: the TRAIN-3 study
BOOG Study Center B.V.43 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2024年11月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 472
- 试验地点
- 43
- 主要终点
- Three-year event-free survival
研究概览
简要总结
To evaluate efficacy of image‐guided de‐escalating chemotherapy in the presence of dual HER2‐blockade with Herceptin® and pertuzumab in HER2‐positive breast cancer, as measured by three‐year event‐free survival
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary infiltrating breast cancer
- •Women of childbearing potential and men must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods (failure rate of <1% per year,) during treatment and for at least seven months after the last dose of pertuzumab/Herceptin®. A woman is considered to be of childbearing potential if she is post‐menarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- •Women who are not postmenopausal (≥12 months of non−therapy‐induced amenorrhea) or surgically sterile must have a negative β‐HCG serum or urine pregnancy test result.
- •Stage II or III disease according to TNM‐staging (8th edition, AJCC). Nodal status must be examined by ultrasound and fine‐needle aspiration or core biopsy in case of suspicious lymph nodes.
- •Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to ASCO/CAP 2013 guideline (locally assessed)
- •Known estrogen‐ and progesteron‐receptor expression of the invasive tumor
- •WHO performance status ≤1
- •Visible breast tumor on contrast enhanced MRI and/or the presence of malignant lymph node(s)
- •Laboratory requirements – within 21 days prior to enrolment: 1) Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l); 2) Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal); 3) Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists; 4) Adequate renal function: creatinine clearance >50 ml/min estimated using the Cockcroft‐Gault equation, or based on a 24‐hour urine collection measurement
- •LVEF ≥50% measured by echocardiography, MUGA, or MRI
排除标准
- •Concurrent breastfeeding
- •Evidence of distant metastases on FDG‐PET
- •Concurrent contralateral or ipsilateral second primary infiltrating breast cancer
- •Concurrent anti‐cancer treatment or another investigational drug
- •Contra‐indication for neoadjuvant chemotherapy
- •Other invasive malignancy unless treated without chemotherapy more than five years ago and without evidence of recurrence. Patients with prior adequately treated basal cell or squamous cell skin cancer are also eligible.
- •Peripheral neuropathy ≥ grade 2 CTCAE v5.0
结局指标
主要结局
Three-year event-free survival
Three-year event-free survival
次要结局
- Overall survival (OS), defined as the time from registration to death from any cause.
- Pathologic complete response in breast and axilla, defined as the absence of invasive tumor cells, irrespective of the presence of in-situ lesions
- Radiologic complete response, defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination
- Concordance between radiologic response and pathologic response: difference in EFS and OS between patient with rCR after 3, 6, and 9 cycles
- Difference in EFS and OS between patient with pCR after 3, 6, and 9 cycles
- Difference in radical resections in rCR and no‐rCR
- Health‐related quality of life
研究者
BOOG Study Center
Scientific
BOOG Study Center B.V.
研究点 (43)
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