EUCTR2011-004704-38-DE进行中（未招募）不适用
Dual blockage with Afatinib and Trastuzumab as neooadjuvant treatment for patients with lo-cally advanced or operable breast cancer receiving taxane-anthracycline containing chemo-therapy (DAFNE study). - DAFNE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning of specific protocol procedures.
- •2. Complete baseline documentation must be sent to GBG Forschungs GmbH.
- •3. Unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is not allowed. Tumor lesion in the breast with a sonographical size of = 2 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
- •4. Operable or locally advanced or inflammatory breast cancer (cT2 - cT4a-d). In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
- •5. Centrally confirmed positive HER2 status detected on core biopsy. HER2-positive is defined as IHC 3+ by a validated test method or FISH/SISH ratio > 2.0. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the Department of Pathology at the Charité, Berlin, prior to randomisation.
- •6. Centrally confirmed hormone receptor status (ER/PgR).
- •7. Age = 18 years.
- •8. Karnofsky Performance status = 80%.
- •9. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomisation. Results must be above 55%.
- •10. Laboratory requirements:
- •- Absolute neutrophil count (ANC) = 2.0 x 109 / L and
- •- Platelets = 100 x 109 / L and
- •- Hemoglobin = 10 g/dL (= 6.2 mmol/L)
- •Hepatic function
- •- Total bilirubin < 1.5x UNL and
- •- ASAT (SGOT) and ALAT (SGPT) = 1.5x UNL and
- •- Alkaline phosphatase = 2.5x UNL.
- •Renal function
- •- Creatinine = 175 µmol/L (2 mg/dL) < 1.5x UNL.
- •11. Negative pregnancy test (urine or serum) within 14 days prior to randomisation for all women of childbearing potential.
- •12. Complete staging work-up within 3 months prior to randomisation. All patients must have bilateral mammography, breast ultrasound (= 21 days), breast MRI (optional), chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scan done. In case of positive bone scan, bone X-ray is mandatory. Other tests may be performed as clinically indicated.
- •13. Patients must be available and compliant for treatment and follow-up. Patients registered on this trial must be treated at the participating or at a cooperating centre.
- •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
- •1. Bilateral breast cancer.
- •2. Prior chemotherapy for any malignancy.
- •3. Prior radiation therapy for breast cancer.
- •4. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilisation) during study treatment.
- •5. Inadequate general condition (not fit for anthracycline-taxane based chemotherapy) as per investigator assessment.
- •6. Previous malignant disease with a disease-free period of less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
- •7. Known or pre-existing interstitial lung disease.
- •8. Known or suspected congestive heart failure (NYHA > I) or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP > 160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
- •9. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- •10. Chronic-inflammatory bowel diseases.
- •11. Pre-existing motor or sensory neuropathy of a severity grade = 2 by NCI criteria.
- •12. No evidence or history of infection (including hepatitis B, C or HIV).
- •13. Definite contraindications for the use of corticosteroids except inhalative corticoids.
- •14. Known hypersensitivity reaction to one of the investigational compounds or incorporated substances used in this protocol.
- •15. Concurrent treatment with:
- •- chronic corticosteroids unless initiated > 6 months prior to study entry and at low dose (= 10 mg methylprednisolone or equivalent).
- •- sex hormones. Prior treatment must be stopped before study entry.
- •- other experimental drugs or any other anti-cancer therapy.
- •16. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
- •17. Male patients.
研究者
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