Phase III Trial to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous (IV) Administration in HER2 Positive Advanced Breast Cancer Who Have Received IV Trastuzumab at Least 4 Months and Without Disease Progression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference
研究概览
简要总结
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within the SC by the administration through the vial or device self-administration in patients with disseminated breast cancer HER2.
详细描述
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with the injection device). Following administration of these four cycles, the patient will decide whether or not to continue with the subcutaneous formulation of trastuzumab every 3 weeks until progression (out of the study). Since the randomization in the study until the start with subcutaneous trastuzumab, patients will receive a treatment cycle of intravenous trastuzumab as usual.
Main objective: Proportion of patients indicate a preference for the use of subcutaneous vs intravenous trastuzumab.
This principal primary objective will be analyzed with the answers to questionnaire of experiences and preferences of the patients (Principal endpoint) The duration of the study has been estimated after 34 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Woman, 18 years old or upper.
- •Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
- •immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)
- •IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)
- •FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.
- •Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
- •No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.
- •Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <
- •Adequate bone marrow function, liver and kidney
- •Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
- •The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
- •The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
排除标准
- •Patients with no advanced breast cancer.
- •Breast cancer patients with tumors HER 2-negative.
- •The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.
- •The patient has uncontrolled brain metastases.
- •Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
- •Known hypersensitivity to trastuzumab or to any of its components.
- •Patients with severe dyspnea at rest or requiring supplemental oxygen.
- •Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.
- •Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
- •The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
研究组 & 干预措施
Arm A: T-IV + T-SC vial + T-SC device
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
干预措施: Trastuzumab Injectable Solution (Drug)
Arm A: T-IV + T-SC vial + T-SC device
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
干预措施: Trastuzumab Injectable Product (Drug)
Arm A: T-IV + T-SC vial + T-SC device
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with vial (Injectable Solution) x 2 cycles, followed by 600mg of T-SC with single injection device (SID) x 2 cycles.
干预措施: Trastuzumab Injection (Drug)
Arm B: T-IV + T-SC device + T-SC vial
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
干预措施: Trastuzumab Injectable Solution (Drug)
Arm B: T-IV + T-SC device + T-SC vial
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
干预措施: Trastuzumab Injectable Product (Drug)
Arm B: T-IV + T-SC device + T-SC vial
Trastuzumab intravenous (T-IV) x 1 cycle (usual dose of Trastuzumab), followed by 600mg of Trastuzumab Subcutaneous (T-SC) with single injection device (SID) x 2 cycles, followed by 600mg of T-SC with vial (Injectable Solution) x 2 cycles.
干预措施: Trastuzumab Injection (Drug)
结局指标
主要结局
Percentage of Participants With Subcutaneous vs. Intravenous Treatment Preference
时间窗: Up to 12 weeks
The percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab was analyzed with the answer to the questionnaire C2, question number 39 (All things considered, what method of administration do you prefer? Subcutaneous; Intravenous; No preference) of experiences and preferences of the patient.
次要结局
- Percentage of Participants With Subcutaneous Treatment (Vial vs Device Administration) Preference(Up to 12 weeks)
- Percentage of Medical Staff With Intravenous vs. Subcutaneous Preference(Up to 12 weeks)
- Percentage of Medical Staff Subcutaneous Device vs. Vial Preference(Up to 12 weeks)
- Patient Time in Healthcare Unit and Sitting in Chair/Bed(An average of 4 months)
- The Number of Participants Who Experienced Adverse Events (AE)(Through study treatment, an average of 12 weeks)