Protocol for Herceptin as Adjuvant Therapy With Reduced Exposure to Chemotherapy, a Randomised Comparison of Trastuzumab vs Trastuzumab+Paclitaxel in Women With HER2-positive Early Breast Cancer Receiving Neoadjuvant Treatment
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: According to previous results from PHARE study, a subgroup of patients with low-risk cancer (< 3 cm) without axillary lymph node involvement or small (< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. Maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer.
PURPOSE: This randomized phase III trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size< 3 cm, N0) early breast cancer.
详细描述
PHARE-C is an open-label, randomized, phase III, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer to allow for comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy.
Non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. Treatment tolerance and cardiac toxicity will be assessed as secondary objectives.
In case of non pCR, a rescue by Trastuzumab emtansine (T-DM1) is planned to control the survival outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor
- •Without suspicious axillary nodes
- •Tumor size < 30 mm
- •Eligibility to receive a weekly paclitaxel based chemotherapy for this cancer
- •Left Ventricular Ejection Fraction (LVEF) obtained and > 50% as measured by echocardiography (Simpson method) or multigated acquisition scan (MUGA) at 3 months (-/+ 1 month)
- •Overexpression of HER-2 in the invasive component of the primary tumor as indicated by one of the following:
- •3+ by immunohistochemistry (IHC) 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
- •With signed Informed consent
排除标准
- •Previous anti-HER2 treatment (except for HERCEPTIN)
- •Cardiac disease or other medical conditions preventing trastuzumab administration
- •Known allergy to trastuzumab, murine proteins or other excipients
- •Pregnant or breastfeeding women
- •Patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons
研究组 & 干预措施
Group A (Paclitaxel + Trastuzumab)
干预措施: Paclitaxel + Trastuzumab (Drug)
Group B (Trastuzumab)
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Time to progression
时间窗: up to 5 years
Time from the date of randomization to the date of progression
次要结局
- Cardiac toxicity(up to 5 years)
- Breast pathological Complete Response (bpCR)(through surgery completion, an average of 12 weeks)
- Overall Survival(up to 5 years)
- Treatment toxicity(up to 5 years)
- Total pathological Complete Response (tpCR)(through surgery completion, an average of 12 weeks)
- Distant metastasis Free Survival(up to 5 years)