EUCTR2016-005157-21-DE进行中（未招募）1 期
A prospective, randomized, multicenter, open-label comparison of pre-surgical combination of trastuzumab and pertuzumab with concurrent taxane chemotherapy or endocrine therapy given for twelve weeks with a quality of life assessment of trastuzumab, pertuzumab in combination with standard (neo)adjuvant treatment in patients with operable HER2+/HR+ breast cancer. - TP-II
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 259
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
- 性别
- Female
入选标准
- •Female patients, age at diagnosis 18 years and older
- •Histologically confirmed unilateral primary invasive carcinoma of the breast
- •Patients must qualify for neoadjuvant treatment as follows:
- •oNo clinical evidence for distant metastasis (M0)
- •oClinical cT1c-T4a-c (participation of patients with tumors > cT2 is strongly recommended) and no evidence for distant metastases (M0)
- •oAll clinical N (participation of patients with cN+, also in case of cT1c, is strongly recommended)
- •oKnown positive HR-status and centrally confirmed HER2+-status by IHC/FISH
- •oPatients need to fulfill adequate blood count and organ function to receive chemotherapy (see exclusion criteria).
- •Tumor block available for central pathology review
- •Performance Status ECOG ? 1 or KI ? 80%
- •Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients
- •Patients of childbearing potential must accept to implement a highly effective (less than 1% failure rate according to Pearl index) non-hormonal contraceptive measures during the study treatment and for 6 months following the last dose of study treatment (trastuzumab and pertuzumab) such as:
- •oIntrauterine device (IUD)
- •obilateral tubal occlusion
- •ovasectomised partner
- •osexual abstinence
- •Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- •The patient must be accessible for treatment and follow-up
- •LVEF > 55%; LVEF within normal limits of each institution measured by echocardiography (within 42 days prior to randomization)
- •Normal ECG (within 42 days prior to randomization)
- •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 207
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances
- •Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- •Non-operable breast cancer including inflammatory breast cancer
- •Previous or concurrent treatment with cytotoxic agents for any reason
- •Concurrent treatment with other experimental drugs and participation in another clinical trial or clinical research project within 30 days prior to study entry is excluded.
- •Male breast cancer
- •Concurrent pregnancy
- •Breastfeeding
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance
- •Known polyneuropathy = grade 2
- •Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including but not confined to:
- •oUncompensated chronic heart failure or systolic dysfunction (LVEF < 55%, CHF NYHA classes II-IV),
- •ounstable arrhythmias requiring treatment i.e., atrial tachycardia with a heart rate = 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block,
- •oAngina pectoris within the last 6 months requiring anti-anginal medication,
- •oClinically significant valvular heart disease,
- •oEvidence of myocardial infarction on electrocardiogram (ECG),
- •oPoorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100 mm Hg).
- •Inadequate organ function including but not confined to:
- •ohepatic impairment (Child Pugh Class C)
- •opulmonary disease (severe dyspnea at rest requiring oxygen therapy)
- •Abnormal blood values:
- •oThrombocytopenia > CTCAE grade 1
- •oIncreases in ALT/AST > CTCAE grade 1
- •oHypokalaemia > CTCAE grade 1
- •oNeutropenia > CTCAE grade 1
- •oAnaemia > CTCAE grade 1
研究者
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