Metastatic or locally advanced breast cancer MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with histologically or cytologically confirmed metastatic or locally advanced breast cancer 2. Patient with Hormone Receptor (ER and PR) ? positive and/or negative and/or unknown status; HER2-positive and/or negative and/or unknown status (patients who have both unknown or negative HR and HER2 status, are not eligible for the study) 3. At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 4. Patient with progression after a first line of treatment in locally advanced/metastatic setting (a line of treatment is defined as at least one normal cycle of chemotherapy) with antracycline and/or taxane (or trastuzumab-based if HER2+) 5. Patient eligible for receiving a second line chemotherapy including gemcitabine, carboplatin and capecitabine. 6. ECOG Performance status ?2 7. Patient with adequate organ function: ? Absolute Neutrophils Count (ANC) ?1.5 x 109/L ? Haemoglobin ?10 g/dL ? Platelets (PTL) ? 75 x 109/L ? AST/ALT ?3 x ULN (?5 x ULN in case of liver metastases) ? Gamma-GT ? 2.5 x ULN (?5 x ULN in case of liver metastases) ? Bilirubin ?1.5 x ULN (?3x ULN in case of liver metastases) ? Normal creatinine or if abnormal creatinine, creatinin clearance ?50 mL/min (Cockcroft and Gault formula) ? Albumin >1 xLLN ? Proteinuria 3 months 9. Female patient, age >18 years 10. Patient weight > 40 kg and BMI >18 11. Female patient of child bearing potential who agrees to use a method of medically acceptable forms of contraception during the study and 3 months after the last intake of study treatment 12. Patient able and willing to comply with study visits and procedures as per protocol 13. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment. 14. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed 15. Patient affiliated to a social security regimen. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Patient intolerant to gemcitabine or carboplatin or capecitabine 2. Prior hormonal therapy only as treatment for metastatic disease without chemotherapy. Patients must have received chemotherapy for their metastatic disease in the first-line setting. Hormone therapy alone is not allowed 3. Treatment with more than one prior cytotoxic regimen for metastatic breast disease 4. Patient with Triple Negative metastatic breast cancer 5. 5. Patient presenting with cardiac disorders defined by at least one of the following conditions: ? Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) ? Patient with cardiac failure class III or IV of the NYHA classification ? Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) ? Syncope without known aetiology within 3 months ? Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 6. Pregnant or nursing female patient 7. Patient presenting at least a grade II peripheral neuropathy 8. Patient treated for a cancer other than breast cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ 9. Patient with active central nervous system (CNS) metastasis (i.e. nonprogressive after surgery and/or radiotherapy and/or radiosurgery, without steroids and antiepileptic requirements) 10. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent ? Previous treatment 11. Patient treated with any investigational agent within 4 weeks prior baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Survival (OS);Primary end point(s): Overall Survival (OS) is defined as the time from the randomization to the date of documented death due to any cause.; Secondary Objective: o Survival rate every 6 weeks until week 24 and every 12 weeks thereafter ? Tumour assessment: o Overall Progression Free Survival (PFS) o PFS rate every 6 weeks until week 24 and every 12 weeks thereafter o Overall Time to progression (TTP) o TTP rate every 4 weeks o Objective response rate (CR + PR) every 6 weeks until week 24 and every 12 weeks thereafter o Control disease rate (CR + PR + SD) at week every 6 weeks until week 24 and every 12 weeks thereafter o Best response during study treatment ? Level of serum CA 15-3 every 6 weeks until week 24 and every 12 weeks thereafter. ? Quality of life assessment according to the EORTC QLQ-C30 questionnaire every 6 weeks until week 24 and every 12 weeks after ? ECOG Performance Status every 6 weeks until week 24 and every 12 weeks after ? Safety profile using the NCI CTC v4.02 classification ? Pharmacokinetics ? CDA activity and pharmacogenomic analysis. ;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Survival o Survival rate at week 6, 12, 18, 24 ? Tumour assessment: o Overall Time to progression (TTP) o PFS rate every 6 weeks until week 24 and every 12 weeks thereafter o TTP rate every 4 weeks o Objective response rate (CR + PR) every 6 weeks until week 24 and every 12 weeks thereafter o Control disease rate (CR + PR + SD) at week every 6 weeks until week 24 and every 12 weeks thereafter o Best response during study treatment ? Level of serum CA 15-3 every 6 weeks until week 24 and every 12 weeks thereafter. ? Quality of life assessment according to the EORTC QLQ-C30 questionnaire every 6 weeks until week 24 and every 12 weeks after ? ECOG Performance Status every 6 weeks until week 24 and every 12 weeks after ? Safety profile using the NCI CTC v4.02 classification ? Pharmacokinetics ? CDA activity and pharmacogenomic analysis. ;Timepoint(s) of evaluation of this end point: Week 6, 12, 18 and 24 | — |
Countries
Czech Republic, France, Greece, Italy, Slovakia, Spain
Contacts
Public ContactConsuelo Pozo
Alpha Bioresearch, S.L.
Outcome results
None listed