Patients with advanced breast cancer MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: XELODA*60CPR RIV 150MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Capecitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure Age ?18 years Able to comply with the protocol Histologically or cytologically confirmed, HER2-negative, pre- or post-menopausal women with adenocarcinoma of the breast with measurable or non-measurable LR or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Life expectancy of >=12 weeks Prior adjuvant chemotherapy is allowed Prior radiation therapy is allowed if:delivered in the adjuvant setting as a part of the treatment of early breast cancerdelivered prior to study entry for the relief of metastatic bone pain, provided that no more than 30% of marrow-bearing bone has been irradiated (if using chemotherapy backbone which is highly myelosuppressive) Adequate haematological function:Absolute neutrophil count (ANC) >=1.5 x 109/L andPlatelet count >=100 x 109/L and Haemoglobin >=9 g/dL (may be transfused to maintain or exceed this level) Adequate liver function: Total bilirubin =50 mL/min AND Urine dipstick for proteinuria =2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous chemotherapy for LR or mBC If patients have received adjuvant chemotherapy, they must have relapsed more than 6 months since the last dose of chemotherapy. However if adjuvant chemotherapy was taxane based, patients are only elegible if they relapsed >= 12 monthsafter last dose of chemotherapy Concomitant hormonal therapy for LR or metastatic disease, however previous hormonal therapy is allowed for adjuvant, LR, or mBC Patients must have received no radiation therapy for the treatment of metastatic disease (apart from those who received it for the relief of metastatic bone pain and with the precautions mentioned above) Evidence of CNS metastases (even if previously treated). If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases Pre-existing peripheral neuropathy NCI CTC-AE Grade >2 at enrolment Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusionCurrent or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day) Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)Clinically significant (i.e. active) cardiovascular disease for example CVA (=II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication Non-healing wound, active peptic ulcer or bone fracture History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of bevacizumab. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolmentKnown hypersensitivity to bevacizumab and any of its excipients, and any of the chemotherapies Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the preliminary antitumor activity of the combination in terms of progression-free survival (PFS).;Secondary Objective: To determine the objective response rate (RR) and overall survival (OS). To evaluate the safety of this regimen.;Primary end point(s): To determine the preliminary antitumor activity of the combination in terms of progression-free survival (PFS). | — |
Countries
Italy
Outcome results
None listed