EUCTR2008-004263-19-DE进行中（未招募）1 期
Randomized comparison of adjuvant Docetaxel / Cyclophosphamide with sequential adjuvant EC / Docetaxel chemotherapy in patients with HER2/neu negative early breast cancer –6 x TC vs. 4 x EC -> 4 x Doc - PLAN B
Westdeutsche Studiengruppe GmbH0 个研究点开始时间: 2008年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •General Inclusion Criteria (Screening)
- •1. Female patients, age at diagnosis 18 - 75 years
- •2. Histological confirmed unilateral primary invasive carcinoma of the breast
- •3. Adequate surgical treatment with complete resection of the tumor (R0) and resection of ? 10 axillary nodes or SLN in clinically N0 patients
- •4. T1 - T4 (if operable, inflammatory breast cancer is excluded)
- •5. Her-2 non-over expressing tumor confirmed by IHC/FISH
- •6. Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization
- •7. Node positive disease or node negative disease with at least one other risk factor (tumor size ? 2 cm, grade ? 2, ER and PR negative, high uPA//PAI-1 levels)
- •8. No evidence for distant metastasis (M0) after conventional staging
- •9. Performance Status ECOG ? 1 or KI ? 80 %
- •10. The patient must be accessible for treatment and follow-up
- •11. Written informed consent for shipping of tumor block for central pathology review and evaluation of Recurrence Score (HR positive) and participation in the planB trial prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- •HR positive patients must also meet all of the following clinical inclusion criteria:
- •12. Patient willingness to participate in adjuvant chemotherapy planB trial if RS > 11
- •13. Indication for chemotherapy given provided either > 4 involved lymph nodes or RS > 11 in 1-3 lymph nodes or N0 disease
- •Additional Inclusion Criteria (Randomisation)
- •All patients with HR negative breast cancer and patients with HR positive (ER and/or PR) tumors and node-positive disease with > 4 involved lymph nodes or 0-3 involved lymph nodes with RS > 11 will be randomized for chemotherapy question if they are meeting all of the following additional inclusion criteria prior to randomisation:
- •14. Laboratory requirements (within 21 days prior to randomization)
- •15. Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
- •16. LVEF within normal limits of each institution measured by echocardiography or MUGA scan and normal ECG (within 42 days prior to randomization)
- •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
排除标准
- •General Exclusion Criteria (Screening)
- •1. HER2 over expression confirmed by IHC/FISH/CISH
- •2. Known hypersensitivity reaction to the compounds or incorporated substances
- •3. Known polyneuropathy ? grade 2
- •4. Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease.
- •5. Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri or ipsilateral ductal carcinoma in-situ (DCISpTis of the breast)
- •6. Non-operable breast cancer including inflammatory breast cancer
- •7. Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •8. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
- •9. Male breast cancer
- •10. Concurrent pregnancy; patients of childbearing potential must implement highly effective (less then 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •11. Breast feeding woman
- •12. Sequential breast cancer
- •13. Lack of patient compliance
- •Additional Exclusion Criteria (Randomisation)
- •14. Inadequate organ function including
- •15. Time since axillary dissection > 42 days
研究者
相似试验
已完成
3 期
Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast CancerPrimary Breast CancerHer2 Non-overexpressingNCT01049425West German Study Group3,198
已完成
2 期
Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancerAdvanced or recurrent esophageal cancerJPRN-UMIN000005877Toho University43
已完成
2 期
A phase II study of neoadjuvant docetaxel/cyclophosphamide (DC) followed by epirubicin/cyclophosphamide (EC) for triple-negative breast cancerbreast cancerJPRN-UMIN000011031Tokyo Women's Medical University34
已完成
不适用
Comparative study of two different induction chemotherapy regimens in head and neck cancerocally advanced head and neck cancerMalignant neoplasm of other and ill-defined sitesCancerISRCTN08658578Shahid Beheshti University of Medical Sciences (Iran)50
未知
3 期
Randomized phase III trial of Docetaxel versus docetaxel plus S-1 for second-line treatment of non-small cell lung cancer (NSCLC)JPRN-UMIN000001826The Japan-multinational Trial Organization860