adenocarcinoma of the breast MedDRA version: 18.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic
Conditions
Interventions
Product Name: Docecal
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: docetaxel
CAS Number: 114977-28-5
Other descriptive name: ANHYDROUS DOCETAXEL
Concentration unit:
Sponsors
Oasmia Pharmaceutical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Only patients to whom all of the following conditions apply will be included in the study: 1. Signed informed consent. 2. Women 18 years or older with histologically confirmed adenocarcinoma of the breast and: a. disease progression after one prior anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer, or b. disease progression during or within 12 months of completing an adjuvant or neoadjuvant anthracycline chemotherapy regimen for locally advanced or metastatic breast cancer. 3. Prior chemotherapy completed at least 3 weeks before randomization (with the exception of oral cyclophosphamide [2 weeks] and nitrosureas or mitomycin [6 weeks]). Prior hormonal therapy in the adjuvant and/or metastatic setting is allowed if completed immediately before study entry. 4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). Measurable tumour lesions are defined as those with a minimum size of 10 mm by CT scan (or no less than twice the slice thickness for scanners with slice thickness > 5 mm). To be considered pathologically enlarged and measurable, a lymph node must be = 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). 5. Eastern Cooperative Oncology Group (ECOG) performance status = 2. 6. Adequate haematological, hepatic and renal function defined as: a. Neutrophils = 1.5 × 109/L, b. Platelets = 100 × 109/L, c. Total serum bilirubin = 1 UNL , d. ASAT and ALAT = 2.5 UNL, e. Alkaline phosphatase = 5 UNL, Patients with ASAT and/or ALAT >1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study. f. Serum creatinine = 2 mg/dL. 7. Negative urine pregnancy test for female patients of childbearing potential. 8. Women of childbearing potential must agree to use adequate method of contraception for the duration of study treatment and for 6 months after the last dose of study drug. 9. Ability and willingness of the patient to follow all requirements of the study protocol. 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 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients to whom any of the following conditions apply must be excluded from the study: 1. Known brain metastases/leptomeningeal involvement. 2. History of hypersensitivity reaction to products containing docetaxel, polysorbate 80 or XMeNa. 3. Definite contraindications for the use of dexamethasone: hypersensitivity to any component of dexamethasone drug formulation, severe infectious diseases. 4. History of significant neurologic or psychiatric disorders including dementia or seizures. 5. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma. 6. Peripheral neuropathy of Grade 2 or higher (NCI-CTCAE, Version 4.0) at randomization. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Concurrent treatment with any other anti-cancer therapy. 9. Prior treatment with taxanes, bone marrow transplantation or stem-cell support. 10. Radiotherapy within 4 weeks prior to screening. 11. Surgery within 2 weeks prior to screening. 12. Participation in other clinical trial with any investigational drug within 30 days prior to enrolment or during participation of the current study. 13. Pregnant or lactating women. 14. Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that Docecal is not inferior to Taxotere®, measured as overall response rate (ORR).;Secondary Objective: The secondary objectives are: • To assess the efficacy of Docecal compared with Taxotere® as measured by secondary efficacy endpoints. • To assess the safety profile of Docecal compared with Taxotere®. ;Primary end point(s): Primary endpoint: The primary efficacy endpoint is overall response rate (partial and complete response) after 6 cycles of chemotherapy, based on the assessments of the Independent Imaging Review Facility (IRF) according to RECIST 1.1 criteria (2009).;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is overall response rate (partial and complete response) after 6 cycles of chemotherapy, based on the assessments of the Independent Imaging Review Facility (IRF) according to RECIST 1.1 criteria (2009). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: Secondary efficacy endpoints are: • Disease control rate • Time to response • Duration of response • Progression free survival • Time to progression • Quality of life using the Functional assessment of cancer therapy measurement system for breast cancer (FACT-B) Safety endpoints are: • Incidence and nature of adverse events • Incidence of events considered to be hypersensitivity reactions • Incidence of events interpreted as fluid retention • Changes in physical examination • Changes in vital signs (body temperature, pulse rate, systolic and diastolic blood pressure) • Changes in electrocardiogram • Changes in laboratory tests (haematology, biochemistry, urinalysis) • Change in ECOG status ;Timepoint(s) of evaluation of this end point: • Disease control rate - a complete response , partial response or stable disease determined by the IRF using RECIST 1.1 criteria. • Time to response is measured from time of randomization to the time measurement criteria are first met for CR/PR. • Duration of response is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death. • Progression free survival - time of randomization until disease progression or death. • Time to progression - time interval between the date of randomization and the date of disease progression. • Quality of life (QOL) using the FACT-B - global QOL score based on the Functional Assessment of Cancer Therapy measurement system for breast cancer (FACT-B) completed by the patient. | — |
Countries
Latvia, Russian Federation, Ukraine
Contacts
Public ContactOasmia Pharmaceutical AB
Oasmia Pharmaceutical AB
Outcome results
None listed