Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 345
- 试验地点
- 20
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
详细描述
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
Patients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) with any breast cancer subtype can be enrolled. All metastases must be available for SABR.
The primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve progression-free survival (PFS).
Secondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).
Exploratory analyses:
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytological confirmed recurrent OMBC.
- •Age ≥18 years old.
- •OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
- •Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
- •Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
- •Patients with local recurrence and OMBC must have a controlled local recurrence.
- •ECOG/WHO 0-
- •Life expectancy > 6 months.
- •Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
- •Symptomatic bone metastases are allowed if ablative therapy can be delivered.
- •Adequate organ function for the planned treatment according to local guide-lines.
- •For patients with liver metastasis:
- •No cirrhosis or hepatitis
- •Hepatic function:
- •Total bilirubin level < 3.0 x institutional ULN
- •ALT, AST, GGT, and alkaline phosphatase levels < 3.0 x institutional ULN
- •Albumin > 2.5 mg/dL
- •Metastasis not adjutant to stomach or small bowel.
- •For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of > 60mL/min.
- •Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.
- •Negative pregnancy test within 14 days prior to start of treatment*.
- •If childbearing potential, willing to use an effective form of contraception*.
- •No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
- •Signed informed consent and willingness to follow the trial procedures.
排除标准
- •> 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included). Change due to toxicity allowed.
- •Oligometastases in brain.
- •Malignant pleural effusion or ascites.
- •Metastasis growth that involves > 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit.
- •Unable to undergo imaging by either CT scan or MRI.
- •Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
- •Pregnancy or breast-feeding.
- •Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
研究组 & 干预措施
Experimental SABR arm
Standard first line systemic therapy + SABR.
干预措施: SABR (Radiation)
Control systemic therapy arm
Standard first line systemic therapy.
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 3 years after the last patient inclusion
Time from the date of randomisation to the date of disease-progression at any site or death from any cause.
次要结局
- Health-related quality of life Cancer-30(At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.)
- Overall survival (OS)(3 years after the last patient inclusion)
- Safety analysis - acute toxicity(From the first dose of SABR to 3 months after the last dose of SABR)
- Health-related quality of life Breast-23(At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.)
- Safety analysis - late toxicity(From the first dose of SABR to 3 years after the last dose of SABR)
- Local Control Rate (LCR)(3 years after the last patient inclusion)