A multi-country, multicenter, randomized, open-label, parallel group study to assess the efficacy and safety of Docecal compared with Taxotere®
- Conditions
- adenocarcinoma of the breastMedDRA version: 18.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005161-12-LV
- Lead Sponsor
- Oasmia Pharmaceutical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 235
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>•To assess the efficacy of Docecal compared with Taxotere® as measured by secondary efficacy endpoints.<br>•To assess the safety profile of Docecal compared with Taxotere®.<br><br>;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 Outcome Measures
Name Time Method