Impact of Breast-Conserving Therapy (BCT) on Recurrence in Patients With Triple-Negative Breast Cancer (TNBC) Compared With Mastectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 464
- 主要终点
- Disease-free survival(DFS)
研究概览
简要总结
RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a high risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent impact of breast-conserving therapy (BCT) and mastectomy on disease-free survival in patients with early breast cancer has been established by a number of large randomized controlled trials and meta-analysis. However, ongoing dispute exists on whether TNBC is a good candidate for BCT.
PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in treating Chinese patients with early TNBC.
详细描述
STUDY POPULATION:
Operable patients with T1-2N0-1M0 triple-negative breast cancer
OBJECTIVES:
Primary To assess the impact of breast-conserving therapy on disease-free survival compared with mastectomy in patients with T1-2N0-1M0 triple-negative breast cancer.
Secondary To assess the impact of breast-conserving therapy on locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS) compared with mastectomy in patients with T1-2N0-1M0 triple-negative breast cancer.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 - 65 years old;
- •Staging of Cancer: cT1-2N0-1M0;
- •Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
- •Definite reports on ER/PR/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);
- •Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
- •ECOG performance score is 0 or 1;
- •No mass or microscopic tumor residue after surgery resection;
- •Informed consent form signed.
- •Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study.
排除标准
- •Bilateral breast cancer;
- •Clinical or radiographic evidence of metastatic disease;
- •Widespread disease that cannot be incorporated by local excision through a single incision that achieves negative margins with a satisfactory cosmetic result;
- •Diffuse suspicious or malignant-appearing microcalcifications;
- •Positive pathologic margin;
- •Any of ER, PR or Her2 is positive;
- •Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
- •Prior history of breast cancer or any other malignant disease (except for basal cell carcinoma and cervical carcinoma in situ);
- •Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study;
- •Known allergic to taxane and anthracycline agents;
- •Pregnant and breast-feeding women;
- •With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups;
- •Without personal freedom and independent civil capacity.
研究组 & 干预措施
Breast-Conserving Therapy
- Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
- Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows:
TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles.
TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles. 3. Within 4-8 weeks after completion of chemotherapy, patients undergo radiation therapy as follows:
N0: Radiation therapy to whole breast (+boost to tumor bed). N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.
干预措施: Adjuvant Chemotherapy (Drug)
Breast-Conserving Therapy
- Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
- Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows:
TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles.
TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles. 3. Within 4-8 weeks after completion of chemotherapy, patients undergo radiation therapy as follows:
N0: Radiation therapy to whole breast (+boost to tumor bed). N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.
干预措施: Breast-Conserving Therapy (Procedure)
Breast-Conserving Therapy
- Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
- Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows:
TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles.
TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles. 3. Within 4-8 weeks after completion of chemotherapy, patients undergo radiation therapy as follows:
N0: Radiation therapy to whole breast (+boost to tumor bed). N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.
干预措施: Radiation Therapy (Radiation)
Mastectomy
- Patients undergo mastectomy (MT) with surgical axillary staging.
- Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows:
TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles.
TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles.
干预措施: Mastectomy (Procedure)
Mastectomy
- Patients undergo mastectomy (MT) with surgical axillary staging.
- Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows:
TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles.
TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles.
干预措施: Adjuvant Chemotherapy (Drug)
结局指标
主要结局
Disease-free survival(DFS)
时间窗: Up to 5 years post-treatment
DFS is defined as time (measured in months) from initial local-regional surgical treatment until first recurrence (local or distant) or last follow-up.
次要结局
- Locoregional recurrence-free survival(LRRFS)(Up to 5 years post-treatment)
- Distant metastasis (DM)(Up to 5 years post-treatment)
研究者
Xiaoming Xie
Chief, Department of Breast Surgical Oncology,Sun Yat-sen University Cancer Center
Sun Yat-sen University