Neoadjuvant Complete Hormonal Blockade Followed by Neoadjuvant Chemotherapy for Resectable Hormone Receptor Positive, HER-2/Neu Negative Breast Cancer, A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Disease-free Survival
研究概览
简要总结
This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery
详细描述
PRIMARY OBJECTIVES:
I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of complete hormonal blockade (CHB) for 2 weeks followed by four three-week cycles of Xeloda, Methotrexate and Navelbine with continuation of complete hormonal blockade.
SECONDARY OBJECTIVES:
I. To assess the clinical response rate in patients with surgically resectable breast cancer treated with complete hormonal blockade and four three-week cycles of Xeloda, Methotrexate and Navelbine.
II. To assess the toxicity associated with these regimens. III. To assess the relapse rate, overall and disease-free survival in patients with operable breast cancer when treated with neoadjuvant CHB and XMN + CHB followed by adjuvant treatment using XMN or Taxol.
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
- •Have histologically confirmed, operable ER or PR +, HER2/neu negative, radiographically measurable breast cancer > 1cm (Operable lesions are T1c - T3 and N0 - N2a; histologic confirmation should be by core needle biopsy only)
- •Be chemotherapy naive
- •Have an ECOG performance status of =< 2
- •Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy [or in whom the status of the ovaries is unknown], with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab)
- •All premenopausal patients must have a baseline FSH and LH
- •ANC >= 1,500
- •Platelet count >= 100,000
- •Serum creatinine =< 1.5 x IULN
- •Estimated creatinine clearance > 50 ml/min
- •Have staging studies and tumor assessment prior to registration
- •Bone density exam must be done within the first 3 months of complete hormonal blockade
- •Have a negative pregnancy test within seven days prior to registration if of childbearing potential
- •Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
排除标准
- •Primary tumor =< 1 cm, not measurable; inflammatory disease
- •Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded (Women of childbearing potential who are not using a reliable and appropriate contraceptive method are excluded; patients must agree to continue contraception for 30 days from the last study drug administration)
- •Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
- •Previous enrollment in an investigational drug study within the last 4 weeks
- •Evidence of distant metastatic disease
- •Prior chemotherapy or hormonal therapy for breast cancer
- •Prior malignancy other than adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, other stage I or II cancer from which the patient has been disease free for at least 5 years
- •History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake
- •Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication or myocardial infarction
- •Major surgery within four weeks of the start of study treatment without complete recovery
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- •Known, existing uncontrolled coagulopathy
- •Unwillingness to give informed consent
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study
研究组 & 干预措施
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: vinorelbine tartrate (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: exemestane (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: triptorelin pamoate (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: capecitabine (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: methotrexate (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: paclitaxel (Drug)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: therapeutic conventional surgery (Procedure)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: radiation therapy (Radiation)
Treatment (hormone therapy and chemotherapy)
See detailed description
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Disease-free Survival
时间窗: Up to 5 years
Kaplan-Meier estimate assessed at 5 years
Number of Participants With Clinical Response
时间窗: 1 month
Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
时间窗: From date of treatment start to surgery
Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
时间窗: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
Overall Survival
时间窗: Up to 5 years
From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.
Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
时间窗: During adjuvant and neoadjuvant chemotherapy
Count of patients with dose reduction, treatment interruption, or treatment discontinuation.
次要结局
- Correlation of Molecular Markers With Response, Time to Progression, and Survival(Weekly during CHB and XMN and pacitaxel)
研究者
Hannah Linden
Principal Investigator
University of Washington