None listed
Conditions
Brief summary
This study is comparing the treatment response to pre-operative chemotherapy with nab-paclitaxel versus paclitaxel in women with breast cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. Trial details Participants in this trial will be randomly (by chance) allocated to receive either 4 cycles of nab-paclitaxel (abraxane) or 4 cycles of paclitaxel, followed by 4 cycles of chemotherapy containing anthracyclines. Approximately 2-4 weeks following chemotherapy the patients will undergo breast surgery as part of local regional treatment. All patients will be followed for 10 years after the date of randomisation in order to evaluate treatment response and safety.
Interventions
Subjects will receive 4 cycles of Abraxane (Investigational Product) (125mg/m2) intravenously over 30 min given week 1, 2 and 3 followed by 1 week rest or the comparator. This will be followed by 4 cycles of anthracycline-containing chemotherapy (AC/EC or FEC - based on clinician decision). AC Doxorubicin 60mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; EC Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; FEC
Subjects will receive 4 cycles of Abraxane (Investigational Product) (125mg/m2) intravenously over 30 min given week 1, 2 and 3 followed by 1 week rest or the comparator. This will be followed by 4 cycles of anthracycline-containing chemotherapy (AC/EC or FEC - based on clinician decision). AC Doxorubicin 60mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; EC Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; FEC Fluorouracil 600mg/m2 Epirubicin 90mg/m2 Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks
Sponsors
Fondazione Michelangelo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. ECOG status 0 or 1. Clinical stage should be either - T2, T3, T4 disease, triple negative - T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumour grade (G II-III). Paraffin-embedded tumour block should be available for central confirmation of eligiblity criteria. Written consent
Exclusion criteria
- contralateral breast cancer or presence of metastatic disease (exception: contralateral in situ ductal cancer) - surgical axillary staging prior to study entry (exception: FNA of 1 axillary node is permitted, and, but not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes) - pregnant and lactating women. - women with childbearing potential unless appropriate contraception as described in protocol - treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for current diagnosed breast cancer. - previous investigational product within 4 weeks of randomisation - patients on therapy with a strong CYP3A4 ihibitor, and on therapy with warferin - previous or concomitant malignancy of other type that could affect compliance. - pre-existing motor or sensory neuropathy of Grade >1 for any reason - patients with hypersensitivity due to drugs containing polyoxyethylene castor oil, or hardened castor oil. - other serious illness or medical condition (examples included in the protocol) - patients with a history of uncontrolled seizures, contral nervous system disorders or psychaitric disability judged to be clinically significant - serious uncontrolled infections or poorly controlled diabetes mellitus - Abonrmal laboratory values at baseline: ANC <1.5 x 109/L; platelet count < 100 x 109/L; Hb < 10g/dL; serum total bilirubin > 1.5xULN (except documented Gilbert's syndrome); ALT > 1.25 x ULN; serum creatinine > 1.5x ULN - Baseline LVEF < 50% by echocardiography or MUGA scan -
Outcome results
None listed