EUCTR2006-004470-26-GB进行中（未招募）不适用
Triple Negative breast cancer Trial. A randomised phase III trial of carboplatin compared to docetaxel for patients with metastatic or recurrent locally advanced ER-, PR- and HER2- breast cancer - TNT
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
- 450
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
- •Histologically confirmed ER-, PR-, HER2- primary invasive breast cancer
- •Allred/quick score <3 or H score <10 or ER and PR negative, if other cut-offs used (e.g., 1%, 5% or
- •10%), see Appendix 3. HER2 negative defined as immunohistochemistry scoring 0 or 1+ for
- •HER2, or 2+ and non-amplified for HER2 gene by FISH or CISH; see Appendix 3.
- •PR unknown but ER- and HER2-, and otherwise eligible. Please arrange urgent PR
- •testing. If PR unknown and PR testing is not possible within a reasonable timeframe,
- •the patient is eligible for the trial provided that ER and HER2 status are negative and
- •all other eligibility criteria are met.
- •Confirmed BRCA1 or 2 mutation carrier, with any ER, PR and HER2 status
- •Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for
- •local therapy but suitable for taxane chemotherapy.
- •TNT Protocol Version 3.0, 18 June 2009
- •NB: Patients who have not received anthracycline based chemotherapy in the
- •adjuvant setting or for locally advanced disease may have received a non-taxane,
- •anthracycline regimen as their first treatment at relapse and are eligible to enter the
- •trial at confirmed progression after the anthracycline treatment
- •Patients with stable, treated brain metastases will be eligible providing informed
- •consent can be given and that other sites of measurable disease are present
- •Patients with bone metastases currently receiving bisphosphonates for palliation will
- •be eligible providing other sites of measurable disease are present
- •ECOG Performance Status 0, 1 or 2 (see Appendix 4)
- •Adequate haematology, biochemical indices (FBC, U & Es)
- •LFTs = Normal bilirubin, AST and/or ALT =3 x ULN if Alk Phos >5 x ULN (or an
- •isolated elevation AST/ALT of =5 x ULN)
- •Adequate renal function – Glomerular Filtration Rate (GFR) of >25mls per minute
- •(see Appendix 5)
- •Written informed consent, able to comply with treatment and follow-up.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •Original primary tumour or subsequent relapse known to be positive for any of ER,
- •PR, or HER2 receptors (defined above and in Appendix 3) unless patient is a known
- •BRCA1 or BRCA 2 mutation carrier
- •Patients unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)
- •Known allergy to platinum compounds or to mannitol
- •Known sensitivity to taxanes
- •Patients with inoperable locally advanced disease suitable for local radiotherapy or an
- •anthracycline containing regimen.
- •Previous chemotherapy for metastatic disease other than an anthracycline as in
- •inclusion criteria above.
- •Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial
- •Previous treatment with a taxane for recurrent locally advanced disease which was
- •not completely excised.
- •Previous treatment with a platinum chemotherapy drug
- •LFTs = Abnormal bilirubin (> ULN) and/or AST and/or ALT >3 x ULN with Alk Phos >5
- •x ULN, or an isolated elevation AST/ALT of >5 x ULN.
- •Patients with a life expectancy of less than 3 months
- •TNT Protocol Version 3.0, 18 June 2009
- •Previous malignancies other than adequately treated in situ carcinoma of the uterine
- •cervix or basal or squamous cell carcinoma of the skin, unless there has been a
- •disease-free interval of at least 10 years
- •Previous or synchronous second breast cancer (unless also confirmed ER-, PR-
- •/unknown and HER2-)
- •Patients with bone limited disease
- •Other serious uncontrolled medical conditions or concurrent medical illness likely to
- •compromise life expectancy and/or the completion of trial therapy
- •Pregnant, lactating or potentially childbearing women not using adequate
- •contraception
- •(documentation of a negative serum HCG pregnancy test should be available for premenopausal
- •women with intact reproductive organs, or women less than two years
- •after the menopause. Fertile women and their partners must use a medically
- •acceptable contraceptive throughout the treatment period and for six months following
- •cessation of treatment. Subjects must be made aware before entering the trial of the
- •risk in becoming pregnant).
研究者
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