NCT06961955招募中2 期
FAST NOVEMBER: A Phase II Randomized Trial of a 5 vs. 9-day Course of Whole Breast Radiotherapy With Boost for Early-stage Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
研究概览
简要总结
The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.
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
盲法说明
Study will have no masking as the treating investigator and patient will need to know their radiation schedule for accurate treatment planning.
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
- •Female participant aged ≥ 18 years.
- •-Participants must have at least one of the following risk factors:
- •Grade 3 invasive histology
- •Estrogen receptor positivity less than 5%
- •Lymphovascular invasion
- •Invasive margins <2mm on surgical pathology
- •DCIS final positive margin
- •Extensive intraductal component
- •Age ≤ 50 years
- •Tumor size > 2 cm
- •Histologically confirmed invasive carcinoma or Ductal Carcinoma In Situ (DCIS) of the breast.
- •Breast cancer stage (AJCC v8) T0-3, N0, M
- •T0 N0 is allowed if whole breast radiation is recommended by the treating physician.
- •Lumpectomy within 84 days of the start of radiation.
- •ECOG Performance Status ≤ 2, or KPS ≥ 50
- •Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia.
- •Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- •< 50 years of age:
- •Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- •Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
- •≥ 50 years of age:
- •Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- •Had radiation-induced menopause with last menses >1 year ago; or
- •Had chemotherapy-induced menopause with last menses >1 year ago
- •Sexually active participants of childbearing potential must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of radiation and for 30 days after radiation.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Bilateral breast cancer.
- •Prior radiation therapy to the chest.
- •Prior chemotherapy.
- •Recurrent disease.
- •Known metastases or node positive.
- •Major chest surgery which is expected to impact study participation 8 weeks prior to starting study drug.
- •Prior breast malignancy in either breast.
- •The diagnosis of any other malignancy which, in the opinion of the Investigator, is likely to negatively impact the subject's safety or ability to participate in the study.
- •Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- •Cardiovascular disorders:
- •Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- •Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
- •Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow, social/ psychological issues, etc.)
- •Significant post lumpectomy complications requiring an unplanned re-operation for surgical complications or admission for IV antibiotics. Re-operation for margins evaluation or nodal evaluation is acceptable. Draining of a seroma is not considered a complication unless it has become infected.
- •Breast neuroendocrine carcinoma or sarcoma histology.
- •Radiation sensitizing disease or condition (e.g. connective tissue disease, li fremani, etc.).
- •Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- •Participants receiving concurrent radiation sensitizing medications or therapies.
研究组 & 干预措施
5 fractions of radiotherapy (Arm 1)
Experimental
干预措施: Radiation Therapy (Radiation)
9 fractions of radio therapy (Arm 2)
Active Comparator
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
24-month Mean breast overall satisfaction Breast - Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.
时间窗: 3 years
To evaluate non-inferiority of 24-month Breast-Q satisfaction with breast score with 5 versus 9 fractions of radiation.
次要结局
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by severity (as defined by the NIH CTCAE, version 5.0)(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by relationship to study treatment.(5 years)
- Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms.(8 years)
- Evaluate non-inferiority of a change in cosmetic scores in the treatment arms with pre-radiation scores to post 24-month scores using the UK photographic assessment and EORTC scales.(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by type(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by severity (as defined by the NIH CTCAE, version 5.0)(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by seriousness(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by duration(5 years)
- Evaluate acute and late radiation-related adverse events (AEs) and serious adverse events (SAEs) between the two arms, characterized by relationship to study treatment.(5 years)
- Evaluate non-inferiority of local and local regional recurrence rate in the treatment arms.(8 years)
- Evaluate non-inferiority of a change in cosmetic scores in the treatment arms with pre-radiation scores to post 24-month scores using the UK photographic assessment and EORTC scales.(5 years)
- 60-month mean breast overall satisfaction Breast-Q scores with 5 fractions of radiation is non-inferior in patient reported outcomes.(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
APBI: 27Gy in 5 Fractions for Early Breast CancerBreast CancerNCT02681107AHS Cancer Control Alberta274
已完成
2 期
Metronomic Chemotherapy by Cyclophosphamide Versus Megestrol in Palliative CancerCancerNCT00420563Centre Oscar Lambret88
已完成
1 期
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in AdultsTuberculosisNCT02074956Aeras60
已完成
4 期
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by StreptococciTonsillitisNCT02712307Ass. Prof. Katarina Hedin433
进行中（未招募）
2 期
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst CaAnatomic Stage 0 Breast Cancer AJCC v8Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast CarcinomaAnatomic Stage IA Breast Cancer AJCC v8NCT06008158City of Hope Medical Center48