NCT01565499已完成2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 13
- 主要终点
- The Residual Cancer Burden Grade III (RCB-III).
研究概览
简要总结
Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.
详细描述
The primary objective of the trial is to determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.
The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery.
The total number of patients to be included in this study is 78 patients.
The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •The breast tumors must be ER positive: more than 1% of stained tumor cells by immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative for HER2 amplification (defined as a ratio of HER2/neu copies to chromosome 17 centromere (CEP17) signals <1.8), according to the local laboratory).
- •Are clear candidates to receive chemotherapy by the investigator criteria.
- •Are at least 18 years of age.
- •Have at least one unidimensionally measurable lesion by RECIST [65] version 1.1, measured by mammogram.
- •Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2
- •Have adequate renal and liver function and bone marrow reserve as follows:
- •Bone marrow: absolute neutrophil count (ANC) > or = 1.500/mm3 (1.5 x 109/L); platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.
- •Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = 2.5 * ULN and Albumin ≥ 2.5 g/dL.
- •Renal: serum creatinine < 1.5 x ULN.
- •Exhibit patient compliance and geographic proximity that allow for adequate follow-up
- •Entry informed consent form signed by the patient.
排除标准
- •Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
- •Synchronous contralateral or multicentric breast cancer.
- •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.
- •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.
- •Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
- •Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
- •Patients with known hypersensitivity to nab-paclitaxel or any of its components.
- •Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria
- •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.
- •Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
- •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.
研究组 & 干预措施
Nab-Paclitaxel
Experimental
The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
The Residual Cancer Burden Grade III (RCB-III).
时间窗: After surgery, up to 4 months
The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population
次要结局
- Caveolin-1 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response(Baseline visit)
- Secreted Protein, Acidic, Cysteine-rich (SPARC) in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response(Baseline visit)
- Molecular Tumor Subtypes According to St. Gallen Criteria 2013 in Pre-treatment Tumor Samples as Predictive Marker of Nab-paclitaxel Response(Baseline)
- Pathologic Complete Response (pCR) Rate(After surgery, up to 4 months)
- Invasive Disease Free Survival (IDFS)(Up to 6 years)
- Rate of Conversion to Breast Conserving Surgery (BCS)(After surgery, up to 4 months)
- Ki67 in Pre-treatment Tumor Samples as Tumor Predictive Marker of Nab-paclitaxel Response(Baseline visit)
- Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)(After surgery, up to 4 months)
- Objective Response Rate (ORR) by Mammogram(After surgery, up to 4 months)
- The Number of Participants Who Experienced Adverse Events (AE)(During treatment and until 30 days after the last dose of each patient study treatment)
研究者
研究点 (13)
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