Evaluate nab-paclitaxel in metastatic breast cancer patients failing a solvent based taxane as (neo-)adjuvant treatment MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Abraxane
Product Name: Nab-Paclitaxel
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg milligram(s)
Conce
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures. 2. Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH. 3. Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer. 4. Relapse within = 24 months after completing (last day of last cycle) (neo-)adjuvant chemotherapy. 5. Documented relapse of either a measurable or a non-measurable lesion according to the modified RECIST criteria. 6. Previous neoadjuvant or adjuvant treatment with a solvent based taxane (paclitaxel or docetaxel) irrespective of dose and duration. 7. Prior endocrine treatment for metastatic / advanced disease is allowed. 8. Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated. 9. Age = 18 years. 10. ECOG Performance Status = 2 (irrespective of restrictions due to breast cancer). 11. Laboratory requirements: • Absolute neutrophil count (ANC) ? 1.5 x 109/L. • Platelets ? 100 x 109/L. • Hemoglobin ? 9 g/dL (? 5.6 mmol/L). • Prothrombin time (PT) or international normalized ratio (INR) ? 1.2x ULN (upper normal limit). • Partial thromboplastin time (PTT) ? 1.2x ULN. • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances. 2. (Neo-)adjuvant therapy not containing a solvent based taxane. 3. (Neo-)adjuvant therapy with nab-paclitaxel. 4. Concurrent hormonal therapy for cancer. 5. Life expectancy less than 3 months. 6. Pre-existing peripheral neuropathy of < grade 2 (per CTCAE). 7. Pre-existing grade 3 or 4 diarrhea. 8. Presence of uncontrolled infection. 9. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with the subject’s safety, provision of informed consent, or compliance to study procedures. 10. Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds during study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine overall response rate (ORR) and to exclude that it is 20% or lower.;Secondary Objective: 1. To determine compliance and toxicity of the therapy. 2. To determine clinical benefit rate (CBR) in patients with measurable disease. 3. To determine duration of response. 4. To determine progression-free survival (PFS). 5. To determine overall survival. 6. To assess biomarkers, e.g. SPARC expression in the tissue of the primary or metastatic tumor. ;Primary end point(s): Overall response (OR) will be assessed according to modified RECIST criteria based on investigator assessments. Missing data on response evaluation will be set to no response. | — |
Countries
Germany
Outcome results
None listed