Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial. - The TAILORx Trial

the All-Ireland cooperative oncology research group (ICORG)0 个研究点目标入组 10,000 人开始时间: 2009年5月12日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Patients with operable histrologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment.
•- Patients will be ER and/or PR-positive.
•- Patients will be axillary node negative.
•- The patients tumor size will be 1.1-5.0cm or 5mm-1cm plus unfavourable histological features.
•- The tumour must be HER2 negative.
•- A tissue specimen from the primary breast cancer must be available for sending to Genomic Health for analysis.
•- Patients must be aged 18-75 years.
•- Patients must have adequate organ functioning.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- invasive malignancies in the last 5 years with the exception of curatively treated basel cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
•- greater than 84 days from the final surgical procedure required to treat the primary tumour.
•- less than 1mm tumour-free margin of resection.
•- prior chemotherapy for this malignancy
•- prior radiation therapy for this malignancy
•- patients who develop breast cancer while receiving a selective estrogen-receptor modulator (SERM) or an aromatase inhibitor for breast cancer prevention or a SERM for other indications. However patients may have received 8 weeks of a SERM or aromatase inhibitor for this malignancy and still be eligible for this study.
•- patients with an anticipated life expectancy of less than 10 years
•- patients with chronic obstructive pulmonary disease requiring treatment
•- patients with chronic liver disease
•- patients with previous history of cerebrovascular accident.
•- patients with a history of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline
•- patients with a chronic psychotic condition or other condition that would impair compliance with the treatment regimen.
•- pregnant or nursing women.
•- patients who have had previous Oncotype DX assay performed, with the exception of patients who have had the assay performed and have a Recurrence Score of 11-25.

发起方

the All-Ireland cooperative oncology research group (ICORG)