2024-515368-29-00进行中（未招募）3 期
"A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer.” RXPONDER
Fundacion Grupo Espanol De Investigacion En Cancer De Mama19 个研究点 分布在 1 个国家目标入组 792 人开始时间: 2024年10月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 792
- 试验地点
- 19
- 主要终点
- Invasive Recurrence
研究概览
简要总结
To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2
- •Patients must be able to receive taxane and/or anthracycline based chemotherapy.
- •Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration.
- •Patients must not require chronic treatment with systemic steroids (inhaled steroids are allowed) or other immunosuppressive agents
- •Patients must not have received an aromatase inhibitor (AI) or a selective estrogen receptor modulator (SERM) such as tamoxifen or raloxifene within 5 years prior to registration.
- •Patients must not be pregnant or nursing due to the possibility of harm to a fetus or nursing infant from this treatment regimen. Women of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of ?reproductive potential? if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
- •No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
- •The Quality of Life and Economic Substudy is permanently closed to accrual effective 12/1/
- •Patients who consented to QOL prior to 12/1/12 should continue to complete QOL forms per their expectation report.
- •All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- •Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed
- •Patients will have undergone axillary staging by sentinel node biopsy or axillary lymph nodes dissection (ALND).
- •Patients must not have inflammatory breast cancer and must not have metastatic disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation, intraoperative radiation or endocrine therapy). Radiation in the opposite breast is acceptable. Partial breast irradiation (including brachytherapy) is not allowed.
- •Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy (with or without planned postmastectomy radiation). Patients must have clear margins (as per local institutional guidelines).
- •Registration of patients who have not yet undergone Oncotype DX® screening must occur no later than 56 days after definitive surgery. (For all patients, Step 2 Registration must occur within 84 days after definitive surgery.) If the Oncotype DX® Recurrence Score is already known and is 25 or less, the patient must be registered to Step 2 immediately following Step 1 registration. If the Oncotype DX® Recurrence Score is already known and is greater than 25, the patient is ineligible.
- •Patients must be females > or = 18 years of age. As the Oncotype DX® Recurrence Score has not been validated in men with breast cancer, men are not eligible for this study
- •Patients must have a complete history and physical examination within 28 days prior to registration
- •Patients must have a performance status of 0-2 by Zubrod criteria
排除标准
- •Patients must not have inflammatory breast cancer and must not have metastatic disease. Patients with a prior diagnosis of DCIS are eligible if they received mastectomy alone (no therapeutic radiation or endocrine therapy). Radiation in the opposite breast is acceptable. Partial breast irradiation (including brachytherapy) is not allowed
- •Patients must not have begun chemotherapy or endocrine therapy for their breast cancer prior to registration
结局指标
主要结局
Invasive Recurrence
Invasive Recurrence
次要结局
- Invasive Disease-Free Survival
- Distant Disease-Free Survival
- Local Disease-Free Interval.
- Overall Survival
研究者
Clinical Operations Department
Scientific
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
研究点 (19)
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