Tratamiento de pacientes con cáncer de mama localmente recurrente o metastásico HER2- positivo que no han recibido previamente quimioterapia para enfermedad localmente recurrente o metastásica. HER2-positive locally recurrent or metastatic breast cancer. MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer MedDRA version: 9.1 Level: LLT Classification code 1000
Conditions
Interventions
Trade Name: XELODA 500 mg comprimidos recubiertos con película
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CAPECITABINA
CAS Number: 154361-50-9
Current Sponsor code: Ro 09-1978
Other
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 years. 2. Histologically or cytologically confirmed breast adenocarcinoma with measurable (per RECIST), locally recurrent or metastatic lesions. 3. Candidates for Xeloda based chemotherapy. Locally advanced disease must not be amenable to resection with curative intent. 4. Documented HER2 positive disease (HER2 overexpression indicated by IHC 3+ and/or FISH + and/or chromogenic in situ hybridization (CISH) + of the primary tumor or a metastasis). 5. Documented ER/PgR status (positive or negative). 6. ECOG Performance Status ? 2. 7. Able and willing to comply with the protocol. 8. Written and signed informed consent prior to beginning study-specific procedures showing the patient?s awareness and willingness to participate in the trial and comply with its proceedings and with the understanding that the patient has the right to withdraw from the study at any time without prejudice. (Note: the informed consent document must be approved by the institution?s Independent Ethics Committee). 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
Exclusion criteria
Exclusion criteria: 1. Previous treatment for locally advanced or mBC other than hormone therapy or radiotherapy. Anti-epidermal growth factor receptor or anti-HER2 agents or vaccines and cytotoxic chemotherapies for locally recurrent or mBC are not allowed. Patients must have fully recovered from side effects of any prior radiotherapy. 2. Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less than 6 months prior to enrolment. The max. cumulative dose received must not have exceeded 360 mg/sqm for doxorubicin or 720 mg/sqm for epirubicin. 3. Chronic daily treatment with corticosteroids and/or with aspirin or clopidogrel. 4. Requirement for concurrent use of the antiviral agent sorivudine, or chemically related analogues, such as brivudine. 5. Minor surgical procedures, within 24 hours prior to enrolment. 6. Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational study. 7. Inadequate bone marrow function, liver function and or renal function 8. Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) > 1.5 or an activated partial thromboplastin time (aPTT) > 1.5 x ULN within 7 days prior to enrolment. ? Note: Patients receiving full dose oral or parenteral anticoagulants may be included as long as anticoagulant dosing has been stable for at least two weeks prior to study entry and the appropriate coagulation monitoring tests are within therapeutic limits. 9. Other primary malignancy (including primary brain tumors) within the last 5 years prior to enrolment, except for adequately treated carcinoma in situ of the cervix, squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. 10. Dyspnea at rest due to complications of advanced malignancy (e.g. pulmonary metastases with lymphangitis) or any condition necessitating supportive oxygen therapy. 11. Evidence of CNS metastasis. 12. Evidence of spinal cord compression caused by metastases. 13. History or evidence upon physical/neurological examination of CNS disease unrelated to cancer (e.g. uncontrolled seizures) unless adequately treated with standard medical therapy. 14. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or anticipation of the need for major surgery during the course of the study treatment. 15. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease 16. Baseline LVEF < 50% measured by either echocardiography or MUGA. 17. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. 18. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrolment. 19. Active infection requiring IV antibiotics at enrolment. 20. Serious non-healing wound, peptic ulcer, or bone fracture. 21. Clinically significant malabsorption syndrome, or inability to take oral medication. 22. Evidence of any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the overall response rate (ORR) in patients with HER2-positive locally advanced or metastatic breast cancer receiving bevacizumab, trastuzumab and capecitabine as first-line treatment for metastatic disease.;Secondary Objective: Secondary objectives are to evaluate: - Progression-Free Survival (PFS) - Overall Survival (OS) - Time to Progression (TTP) - Safety and tolerability;Primary end point(s): The primary efficacy endpoint is ORR defined as the percentage of patients with CR or PR, as assessed by RECIST. | — |
Countries
Denmark, France, Slovakia, Spain, Sweden
Outcome results
None listed