Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 26
研究概览
简要总结
RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
详细描述
OBJECTIVES:
- Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients undergo mastectomy followed by radiotherapy.
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Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:
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Regimen A: Patients receive radiotherapy alone.
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Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.
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Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed locally advanced breast cancer
- •T3 inoperable, N0-N2
- •Any T, N2
- •T4, N0-N2
- •Inflammatory breast carcinoma
- •Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks
- •Residual tumor size less than 5 cm
- •No fixed axillary lymph nodes
- •No multifocal or bilateral breast cancer
- •No clinical suspicion of extensive ductal carcinoma in situ
- •No unresolved skin edema
- •No distant metastases (including ipsilateral supraclavicular node)
- •Positive bone scan allowed provided there are no bone metastases on x-ray
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times normal
- •SGOT and SGPT no greater than 2 times normal
- •Alkaline phosphatase no greater than 2 times normal
- •Creatinine less than 1.5 times normal
- •No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix
- •No serious underlying medical illness that would preclude study
- •No psychiatric or addictive disorder that would preclude study
- •No contraindication to study treatment
- •Not pregnant
- •Fertile patients must use effective barrier contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •No concurrent hormonal replacement therapy
- •No concurrent oral contraceptives
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy for breast cancer
- •No prior surgery for breast cancer other than biopsy for diagnosis confirmation
- •No other prior systemic therapy for breast cancer
排除标准
- 未提供