EUCTR2006-000562-36-BE进行中（未招募）1 期
ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study. A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. - ALTTO
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8,000
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
- All
入选标准
- •1. Age > or = 18 years;
- •2. Eastern Cooperative Oncology Group performance status < or = 1;
- •3. Non-metastatic operable primary invasive adenocarcinoma of the breast fulfilling the following:
- •a. Histologically confirmed;
- •b. Adequately excised (exceptions: patients who have 'non-resectable' deep margin invasion or histologically documented infiltration of the skin (pT4) are eligible provided they have had or will receive radiotherapy);
- •c. Axilla dissected; sentinel node sampling is allowed provided that axillary dissection follows confirmation of a positive sentinel node (sentinel node sampling alone is not acceptable after neo-adjuvant chemotherapy);
- •d. Axillary node positive patient or node negative patient with a tumor of more than 1 cm in greatest diameter (> or = T1c);
- •4. Known hormone receptor status (ER/PgR or ER alone);
- •5. Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen;
- •For design 1: Randomisation must be performed no longer than 12 weeks from day 1 of the last chemotherapy cycle.
- •For design 2: Randomisation must be performed no longer than 6 weeks from day 1 of the last anthracycline-containing chemotherapy cycle.
- •For design 1 & 2: Study treatment should start no more than 14 days after randomization;
- •6. Baseline LVEF > or = 50% after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies);
- •7. Confirmed overexpression and/or gene amplification of ErbB2 (HER2) in the invasive component of the primary tumour, according to one of the following definitions:
- •– 3+ overexpression by IHC (>30% of invasive tumour cells);
- •– 2+ or 3+ (in 30% or less neoplastic cells) overexpression by IHC and positive in situ hybridisation (FISH/CISH) test;
- •– ErbB2 (HER2) gene amplification by FISH/CISH;
- •- Patients with a negative or equivocal overall result for overexpression and/or gene amplification are not eligible for participation in the trial;
- •- Equivocal local results may be submitted for a final determination by the central laboratory.
- •8. Completion of all necessary baseline laboratory and radiological investigations;
- •9. Signed written informed consent prior to any study specific screening procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria are not eligible for this study:
- •1. History of any prior (ipsi- and/or contralateral) invasive breast carcinoma;
- •2. Past (less than 10 years) or current history of malignant neoplasms, unless curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •NOTE: Patients with a prior malignancy diagnosed greater than 10 years in the past who have been curatively treated with surgery ONLY, WITHOUT radiation therapy
- •or systemic therapy (chemotherapy or endocrine) are eligible for the study. Patients with any prior diagnosis of breast cancer or melanoma, at any time, are excluded
- •from this study.
- •3. Any clinically staged T4 tumour, including inflammatory breast cancer;
- •4. Bilateral tumours;
- •5. This exclusion criterion has been removed as of protocol amendment 1.
- •6. Maximum cumulative dose of doxorubicin >360mg/m2 or maximum cumulative dose of epirubicin >720mg/m2 or any prior anthracyclines unrelated to the present breast cancer;
- •7. Previous (neo-) adjuvant chemotherapy with peripheral stem cell or bone marrow stem cell support;
- •8. Any prior mediastinal irradiation except internal mammary node irradiation for the present breast cancer;
- •9. Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement;
- •10. Prior anti-ErbB2 (HER2) therapy for any reason, or other prior biologic or immunotherapy for breast cancer;
- •11. Concurrent anti-cancer treatment, except hormonal therapy or radiotherapy for the present breast cancer;
- •12. Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy unless approved by the Executive Committee;
- •13. Serious cardiac illness or medical conditions including but not confined to:
- •– History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF < 50%) ;
- •– High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV-block, supraventricular arrhythmias which are not adequately rate-controlled);
- •– Angina pectoris requiring antianginal medication;
- •– Clinically significant valvular heart disease;
- •– Evidence of transmural infarction on ECG;
- •– Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg);
- •14. Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness;
- •15. Any of the following abnormal laboratory tests immediately prior to randomisation:
- •– serum total bilirubin;
- •– alanine amino transferase (ALAT) or aspartate amino transferase (ASAT);
- •– alkaline phosphatase (ALP);
- •– serum creatinine;
- •– total white blood cell count (WBC);
- •– absolute neutrophil count;
- •– platelets;
- •16. Unresolved or unstable serious toxicity from prior adjuvant chemotherapy or radiotherapy;
- •17. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or persons unable to swallow oral medication. Patients with ulcerative colitis are also excluded;
- •18. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test - urine or serum - within 7 days prior to randomisation);
- •19. Women of childbearing potential including women whose last menstrual period was <1 year ago (unless surgically st
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