EUCTR2011-004476-10-ES进行中（未招募）1 期
Phase II, open-label, non-randomized study of nab-paclitaxel for the neoadjuvant treatment of patients with stage II and III luminal breast cancer.
Fundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)0 个研究点目标入组 78 人开始时间: 2011年11月22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
- 入组人数
- 78
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
入选标准
- •1. Female patients with histologically confirmed diagnosis of primary unilateral
- •invasive early breast cancer with longest tumor size in breast 2cm, or < 2 cm with
- •axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be 2cm (unless axillary involvement) and is
- •designated as the ?target? lesion for all subsequent tumor evaluations.
- •2. The breast tumors must be ER positive: more than 1% of stained tumor cells by IHC, and HER2 negative: 0, or 1+ score by IHC, or 2+ with FISH/CISH negative for
- •HER2 amplification (defined as a ratio of HER-2/neu copies to chromosome 17
- •centromere (CEP17) signals <1.8), according to the local laboratory).
- •3. Are clear candidates to receive chemotherapy by the investigator criteria.
- •4. Are at least 18 years of age.
- •5. Have at least one unidimensionally measurable lesion by RECIST version 1.1,
- •measured by mammogram.
- •6. Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2
- •7. Have adequate renal and liver function and bone marrow reserve as follows:
- •? Bone marrow: ANC ³ 1.500/mm3 (1.5 x 109/L); platelet count ³ 100.000/mm3
- •(100.0 x 109/L); and hemoglobin ³ 9 g/dL.
- •? Hepatic: bilirubin £1.5 times the upper limit of normal (x ULN); alkaline
- •phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase
- •(ALT) £2.5 × ULN and Albumin 2.5 g/dL.
- •? Renal: serum creatinine <1.5 x ULN.
- •8. Exhibit patient compliance and geographic proximity that allow for adequate followup
- •9. Entry informed consent form signed by the patient.
- •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 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •1. Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
- •2. Synchronous contralateral or multicentric breast cancer.
- •3. Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis.
- •4. Second primary malignancy, except adequately treated carcinoma in situ of the
- •cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell
- •carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and
- •lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was
- •diagnosed and definitively treated more than 5 years ago with no subsequent
- •evidence of recurrence.
- •5. Prior or concurrent anti-cancer therapy for current disease (hormone therapy,
- •chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
- •6. Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
- •7. Patients with known hypersensitivity to nab-paclitaxel or any of its components.
- •8. Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria
- •9. Have received treatment within the last 4 weeks with a drug that has not
- •received regulatory approval for any indication at the time of study entry.
- •10. Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
- •11. Patient is pregnant or breast feeding or planning to become pregnant within
- •the six months after the end of treatment. Women with child-bearing potential
- •must be performed a pregnancy serum or urine testing within 7 days prior to
- •study entry according to institutional standards and should use an adequate
- •non-hormonal contraceptive method (intra-uterine contraceptive device,
- •barrier method of contraception in conjunction with spermicidal jelly or
- •surgically sterilized) during treatment with study drugs and within the six
- •months after the end of treatment.
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