EUCTR2005-004263-35-FI进行中（未招募）不适用
A randomised multi-center Phase IIIb, open label, study of letrozole vs anastrazole in the adjuvant treatment of postmenopausal women with hormone receptor and node positive breast cancer - N/A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,032
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of written informed consent.
- •2. Patient must be female.
- •3. Patient must have undergone primary breast cancer surgery with institutional standard axillary dissection such as the following:
- •A total mastectomy with institutional standard axillary nodal dissection.
- •A lumpectomy or a quadrantectomy with institutional standard axillary dissection with breast radiotherapy (may be deferred until chemotherapy is completed) in accordance with breast preservation.
- •Treatment of the breast cancer following diagnosis may have included any of the following: post-lumpectomy/quadrantectomy regional radiotherapy, post-mastectomy locoregional radiotherapy, postoperative chemotherapy, and trastuzumab.
- •4. The tumor must have been pathologic or clinical stage IIA to IIIC invasive carcinoma of the breast documented by core needle or open biopsy. Patients with Paget’s disease of the nipple are eligible.
- •5. The date of randomization must be no more than:
- •12 weeks from completion of surgery or adjuvant chemotherapy
- •Investigators are encouraged to enroll patients as soon as possible after the completion of adjuvant chemotherapy.
- •Note adjuvant radiation and endocrine therapy e.g. letrozole and anastrozole can be given at the same time as radiotherapy due to non-overlapping toxicity profile.
- •6. Presence of node positive disease.
- •Positive node is defined as the presence of at least micro metastasis greater than 0.2 mm according to the AJCC Breast Staging Criteria Edition 6.
- •7. Patients who have had neoadjuvant chemotherapy are eligible. Positive lymph node involvement can be defined either prior to neoadjuvant chemotherapy or at the time of surgery following their neoadjuvant therapy. Lymph node positivity would bedefined as the following: REFER TO CURRENT PROTOCOL FOR DETAILS
- •8. Presence of occult axillary lymph node (pN1-pN3b) with no evidence of primary breast tumor (T0) or only DCIS identified and whose metastases are isolated to axillary lymph nodes associated with the following:
- •Lymph node reflects invasive adenocarcinoma histology
- •Measurement of ER, PR, and HER2 must be performed on initial lymph nodes that were biopsied.
- •Complete staging evaluation required as per standard institutional practices to exclude any other primary sites of disease, including metastatic disease.
- •9. Bilateral, synchronous breast cancer is allowed provided at least one of the primary tumors meets the eligibility criteria.
- •10. Hormone receptor-positive tumors, defined as any detectable estrogen or progesterone receptor expression by institutional standards. Patients who are PR positive and ER negative are eligible for the trial. Tumor slides should be submitted for central evaluation of hormone receptor status as per Section 3.5.3.3.7 and Post-text Supplement 2.
- •11. HER2 status must be known.
- •Note if possible tumor slides should be submitted for central confirmation of hormone and HER2 receptor status as per Section 3.5.3.37 and Post-test Supplement 2.
- •12. Physical and laboratory examinations, as per standard institutional practice, should be obtained at the time of definitive surgery to demonstrate there is no evidence of metastatic or recurrent disease.
- •13. Patients must have an WHO performance status of 0 or 1(0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory)
- •14. Patients must be postmenopausal at the time of initial diagnosis. For study purposes
排除标准
- •1. Presence of metastatic disease or inflammatory breast cancer as documented by dermal lymphatic invasion.
- •2. Presence of metachronous bilateral breast cancer.
- •3. Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years except in situ carcinoma of the cervix or curatively treated basal and squamous cell carcinoma of the skin.
- •4. Presence of other non-malignant systemic diseases which may prevent prolonged follow-up.
- •5. Received neoadjuvant endocrine therapy
- •6. Hormone replacement therapy (HRT) other than Estring®, Vagifem® or low dose estrogen vaginal cream, not stopped at least 4 weeks before randomization. Thyroid replacement, insulin or other anti-diabetic medication are permitted to be continued.
- •7. Adjuvant anti-estrogen therapy for more than 1 month immediately following surgery, radiotherapy and/or chemotherapy.
- •8. Breast cancer chemoprevention with anti-estrogens if less than 18 months between stopping and diagnosis of breast cancer.
- •9. Severe hepatic dysfunction defined as Child-Pugh grade C. REFER TO TABLE 3-2 IN THE CURRENT PROTOCOL
- •10. Therapy with any hormonal agent such as raloxifene for management of osteoporosis. (Patients are eligible only if these medications are discontinued 4 weeks prior to randomization.)
研究者
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