Prospective Validation Trial of Taxane Therapy (Docetaxel or Weekly Paclitaxel) and Risk of Chemotherapy-Induced Peripheral Neuropathy in African American Women
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
- 试验地点
- 979
- 主要终点
- Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A
研究概览
简要总结
This phase II trial studies how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in African American patients with stages I-III breast cancer. Drugs used in chemotherapy, such as docetaxel and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving docetaxel or paclitaxel may work better than other methods in reducing chemotherapy-induced peripheral neuropathy in patients with breast cancer.
详细描述
PRIMARY OBJECTIVE:
I. Prospectively validate a prior germline predictor of paclitaxel-induced peripheral neuropathy (TIPN) using the Common Terminology Criteria for Adverse Events (CTCAE). Specifically, this study will demonstrate that patients with a high-risk TIPN genotype have significantly more grade 2-4 TIPN than patients with a low risk genotype.
SECONDARY OBJECTIVES:
I. Validate a prior germline predictor of TIPN using the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) neurotoxicity subscale in Arm A.
II. Compare grade 2-4 TIPN based on CTCAE between weekly paclitaxel (Arm A) versus (vs.) every three-week docetaxel (Arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients must be women with a known stage I-III invasive breast cancer diagnosis
- •Patients must be capable and willing to provide informed consent
- •Patients must have plans to receive either neoadjuvant or adjuvant:
- •Every 3-week docetaxel x 4-6 cycles OR
- •Weekly paclitaxel x 4 cycles
- •NOTE: Recommended therapies for various therapy regimens are outlined based on estrogen receptor (ER)/progesterone receptor (PR)/HER2 and nodal status. Where there are options, the treating physician will choose a regimen best fitted for that patient. If the physician does not feel any of the regimens are the best fit for the patient, the patient should not be enrolled. Physicians will also document why a regimen was felt to be inappropriate when an option. Patients who have already started the anthracycline portion of their therapy are eligible assuming they have not yet begun the taxane portion and assuming they will be receiving one of the regimens deemed appropriate for her disease setting
- •Patients must self-identify their race as black, African American, or of African descent; patients may be of any ethnicity
- •Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
排除标准
- •Patients must not have received prior taxane or prior/concurrent platinum therapy
- •Patients must not have received neoadjuvant anti-HER2 therapy
- •Patients must not have pre-existing peripheral neuropathy
- •Patients must not have a total bilirubin > upper limit of normal (ULN) (must be obtained within 3 weeks prior to registration)
- •Patients must not have aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 1.5 times the ULN concomitant with alkaline phosphatase above 2.5 times the ULN (must be obtained within 3 weeks prior to registration)
- •Patients must not be pregnant or lactating
- •All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- •A patient of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
研究组 & 干预措施
Arm A (paclitaxel)
Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Quality-of-Life Assessment (Other)
Arm A (paclitaxel)
Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Questionnaire Administration (Other)
Arm B (docetaxel)
Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Questionnaire Administration (Other)
Arm B (docetaxel)
Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Quality-of-Life Assessment (Other)
Arm A (paclitaxel)
Patients receive paclitaxel IV over 3 hours once weekly. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive trastuzumab and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Paclitaxel (Drug)
Arm B (docetaxel)
Patients receive docetaxel IV over 1 hour once every 3 weeks. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive cyclophosphamide, doxorubicin, trastuzumab, and/or pertuzumab per institution routine care per treating physician's discretion.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Percentage of Participants With Grade 2-4 Taxane-Induced Peripheral Neuropathy (TIPN) by Genotype Risk Group in Arm A
时间窗: assessed at baseline, an end of each cycle, at 6 months and 1 year post registration
Grade 2-4 TIPN was assessed by treating physician using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. All patients who started protocol therapy on arm A (paclitaxel) were included in the analysis. The percentage of participants with grade 2-4 TIPN was calculated based on binomial distribution and was compared between high-risk vs low-risk genotype groups using Fisher exact test. Genotype risk group (high vs. low) was determined by genotyping. High-risk genotype was defined by FCAMR GG genotype (homozygous wild type) or SBF2 mutated. Low-risk genotype was defined by carriage of at least one variant allele in FCAMR (AG or AA) and SBF2 wild-type status.
次要结局
- Patient-Reported Neuropathy Score Change Between Baseline and End of Treatment by Genotype Risk Group in Patients on Arm A(assessed at baseline and at end of treatment, an average of 3 months)
- Percentage of Participants With Grade 2-4 TIPN Based on CTCAE Between Arm A and Arm B(assessed at baseline, an end of each cycle, at 6 months and 1 year post registration)
- Percentage of Participants With Dose Reduction Due to TIPN Between Arm A and Arm B(Dose reduction due to TIPN was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B)
- Percentage of Participants With Dose Reduction Due to Any Reason Between Arm A and Arm B(Dose reduction due to any reason was assessed at end of each cycle, up to 4 cycles in arm A and 6 cycles in arm B)
- Percentage of Participants With Grade 2-4 TIPN by Genotype Risk Group in Arm B(assessed at baseline, at end of each cycle, at 6 months and 1 year post registration)