EUCTR2010-018389-22-HU进行中（未招募）1 期
A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm. - ELATE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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. Signed written informed consent approved by an Independent Ethics Committee
- •(IEC) and obtained prior to any study specific screening procedures.
- •2. Female patients aged =18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0 –1.
- •4. Histologically confirmed, previously untreated, operable Stage I-IIIA invasive breast cancer:
- •Primary tumour greater than 1 cm in diameter measured by clinical
- •examination and confirmed by at least one imaging study (mammography,
- •breast ultrasound or MRI).
- •In the case of a multifocal tumour (defined as the presence of two or more
- •foci of cancer within the same breast quadrant), the largest lesion must be >1
- •cm and is designated as the target” lesion for all subsequent tumour evaluations.
- •5. Over expression and/or amplification of ErbB2 in the invasive component of the
- •primary tumour according to one of the following definitions. Central laboratory
- •confirmation is not required prior to randomization, but tumour samples must be
- •available for banking and retrospective confirmation.
- •3+ over expression by IHC (>30% of invasive tumour cells);
- •2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in
- •situ hybridization (FISH/CISH) test demonstrating ErbB2 gene amplification;
- •ErbB2 gene amplification by FISH/CISH (>6 ErbB2 gene copies per nucleus,
- •or a FISH ratio [ErbB2 gene copies to chromosome 17 signals] of >2.2.)
- •Patients with a negative or equivocal overall result (FISH test ratio of =2.2, =6.0
- •ErbB2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less
- •neoplastic cells) by IHC are NOT eligible for participation in the trial.
- •6. Known ER and PgR hormone receptor status.
- •7. LVEF within institutional normal range (evaluated by multiple-gated acquisition
- •[MUGA] or echocardiography).
- •8. Women of childbearing potential must have a negative serum pregnancy test within 14 days (preferably 7 days) of first dose of study treatment and agree to use effective contraception, as defined in Section 7.3.2, during the study and for 28 days following the last dose of study drug.
- •9. Adequate baseline organ function defined by:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L,
- •Hemoglobin = 9 g/dL,
- •Platelet count = 100 x 109/L,
- •Serum bilirubin =1.5 x ULN. In the case of known Gilbert´s syndrome, < 2x
- •ULN is allowed,
- •ALT and AST = 2.5 x ULN,
- •Alkaline phosphatase = 2.5 x ULN,
- •Serum creatinine = 1.6 mg/dL or calculated creatinine (Cockcroft and Gault )
- •clearance =50mL/m.
- •10. Patient agrees to make available tumour tissue samples for submission to the central laboratory for planned as well as future translational research.
- •11. French subjects: In France, a subject will be eligible for inclusion in this study only
- •if either affiliated to or a beneficiary of a social security category.
- •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. Metastatic, locally advanced, or inflammatory breast cancer as defined by the AJCC
- •(7th Edition).
- •2. Bilateral breast cancer.
- •3. Multicentric breast cancer (defined as the presence of two or more foci of cancer in
- •different quadrants of the same breast).
- •4. Any prior treatment for primary breast cancer (other than excision of tumour in the
- •contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy, all of which exclude the patient).
- •5. Concurrent participation in another clinical trial involving anti-cancer investigational
- •drug or administration of an investigational drug within 30 days or 5 half-lives,
- •whichever is longer, preceding the first dose of study treatment.
- •6. History of any prior malignancy in previous 5 years (patients with a history of
- •completely resected non-melanoma skin cancer or successfully treated carcinoma in
- •situ of the cervix are eligible).
- •7. History of significant comorbidities that interfere with the conduct of the study, or
- •evaluation of the results, or with informed consent.
- •8. Active infection.
- •9. Peptic ulcer or unstable diabetes mellitus within 8 weeks prior to study enrolment.
- •10. Clinically significant (i.e. active) cardiovascular disease, including cerebrovascular
- •accident (=6 months before enrolment), myocardial infarction (=6 months before
- •enrolment), unstable angina, New York Heart Association (NYHA) = grade 2
- •congestive heart failure, serious cardiac arrhythmia requiring medication during the
- •study and that might interfere with regularity of the study treatment, or not controlled by medication.
- •11. Subjects who have current active hepatic or biliary disease (with exception of
- •patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver
- •disease per investigator assessment).
- •12. Lactating women.
- •13. Subjects unable to swallow and retain orally administered medication or with any
- •clinically significant gastrointestinal abnormalities that may alter absorption such as
- •malabsorption syndrome, major resection of the stomach or bowels, or ulcerative
- •colitis are also excluded.
- •14. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other
- •conditions that could interfere with subject’s safety, obtaining informed consent or
- •compliance to the study procedures, in the opinion of the Investigator.
- •15. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to any of the study drugs, active ingredients, or excipients that contraindicates their
- •participation.
- •16. Concomitant use of CYP3A4 inhibitors or inducers (see Section 6.2 for list of
- •prohibited medications).
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