PER-015-09已完成未知
Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2009年7月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 76（—）
- 性别
- Female
入选标准
- •Patients should have histologically confirmed breast adenocarcinoma with significant risk of distant recurrence in at least one of the following criteria: Commitment of at least one axillary lymph node in the routine histological examination. Patients with axillary node involvement demonstrated only by immunohistochemistry are not eligible unless they meet one of the following eligibility criteria: Negative ER tumor> 1 cm, RE + tumor> 5 cm. regardless of recurrence score, RE + tumor> 1 cm. but <5 cm. with a recurrence score> 11. (Patients recruited in the TAILORx trial are eligible.)
- •Patients should have complete definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and axillary node biopsy, breast conservation and axillary dissection surgery or breast conservation surgery and sentinel node biopsy.
- •The margins of conservation surgery or mastectomy should be histologically free of invasive breast cancer or ductal carcinoma in situ (COIS). Patients with positive resection margins for lobular carcinoma in situ (CLIS) are eligible.
- •The Interval between the last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) and Day 1 of treatment should be> 28 days and <84 days.
- •ECOG operating status of 0-1
- •Patients must have adequate organ function within <8 weeks prior to randomization.
- •Patients who have undergone breast conservation surgery should receive radiation. Prior to randomization, the researcher must specify the planned radiation technique,
- •Post-mastectomfa RT is required for all patients with a main tumor> 5 cm. or commitment of 4 to more lymph nodes. Post-mastectomy RT is administered at the discretion of the investigator for all patients with another mastectomy.
- •Patients with synchronous bilateral breast cancer (diagnosed in the last month) are eligible if the major TMN stage tumor meets the eligibility criteria of this trial.
- •Patients should not have received previous cytotoxic or hormonal chemotherapy for this breast cancer. Previous treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed.
- •Patients should not have had major surgical procedures within 28 days of day 1 of treatment.
- •Patients requiring full dose anticoagulation can be recruited
- •Male or female patients of age> 16 years of age are eligible.
- •Women with potential fertility and sexually active men should use an accepted and effective method of contraception.
排除标准
- •Patients with HER2 + (3+ for IHC or F1SH +) breast cancer are not eligible.
- •Patients with clinical evidence of inflammatory disease or axillary nodes fixed in the diagnosis.
- •Patients who have had a vascular access device within 24 hours of planned Day 1 of the protocol treatment.
- •Patients with clinically significant cardiovascular or cerebrovascular disease
- •Patients with bleeding diathesis, inherited or acquired bleeding disorder or coagulopathy.
- •Patients who present a wound or fracture that does not heal. Patients with abdominal fistula, or intra-abdominal access at 6 months prior to randomization are not eligible.
- •Patients with hypersensitivity to Paditaxel or drugs that use the Cremophor vehicle, hamster ovary cell products or other recombinant human antibodies.
- •Women who are pregnant or breastfeeding due to the potential harmful effects of Bevacizumab on the developing fetus. All women with potential fertility must have a blood or urine test within 7 days prior to randomization to rule out pregnancy.
研究者
相似试验
招募中
4 期
Doxorubicin, Cyclophosphamide followed by Paclitaxel vs. 5-FU, Doxorubicin, Cyclophosphamide in locally advanced Breast Cancerocally advanced breast cancerTCTR20170711001Bangabandhu Sheikh Mujib Medical University154
进行中（未招募）
不适用
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone plus Rituximab (CPOP-R) in Elderly Patients with Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial'Diffuse Large-Bcell LymphomaMedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2005-001100-40-ITCELL THERAPEUTICS INC. SEDE SECONDARIA280
进行中（未招募）
不适用
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone plus Rituximab (CHOP-R) andCyclophosphamide, Pixantrone, Vincristine, Prednisone plus Rituximab (CPOP-R) inPatients with Diffuse Large-B-cell Lymphoma: A Phase II, Randomized,Multicenter, Comparative TrialDiffuse large B-cell lymphoma.MedDRA version: 13.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2005-001100-40-DECell Therapeutics Europe S.r.l.280
进行中（未招募）
不适用
Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) versus gemcitabine, cisplatin and methyl prednisolone (GEM-P) in the first line treatment Of T-cell Lymphoma, a multicentre randomised phase II studyEUCTR2011-004146-18-GBThe Royal Marsden NHS Foundation Trust186
Unknown
2 期
Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast CancerBreast CancerNCT00994968Yonsei University49