Evaluation of masitinib combined to gemcitabine, carboplatin or capecitabine in patients with a metastatic or locally advanced breast cancer relapsing after a first chemotherapy treatment

Phase 1

• Conditions: Metastatic or locally advanced breast cancer; MedDRA version: 18.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022646-24-GR
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-06
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 54

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 < 30 mg/dL (1+) on the dipstick; if proteinuria is = on the dipstick, 24 hours proteinuria must be <1.5g/24 hours
8. Patient with life expectancy >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.
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

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. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified