A Phase 2 interventional study of Paclitaxel 80 mg/m2 and Nab-paclitaxel 100 mg/m2 days 1, 8 and 15 in Breast Cancer, sponsored by Fundacion Oncosur. Completed at 10 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-29.
Sponsored by Fundacion Oncosur · Phase 2, Interventional, and Diagnostic
Nanomedicines are currently being developed in the treatment of cancer due to their pharmacological advantages over traditional formulations; they provide a shorter infusion time and lower risks of hypersensitivity reactions associated with commonly used solvents.
Nab-paclitaxel is a nanoparticle albumin-bound particle form of paclitaxel that is thought to exploit natural albumin pathways to enhance the selective uptake and accumulation of paclitaxel at the site of the tumour, thus reducing its diffusion to normal tissues.
Nab-paclitaxel has been approved for the treatment of metastatic breast cancer patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.
SPARC is a cysteine rich acid protein that is overexpressed in a broad proportion of solid tumours. Expression of this protein could sensitize tumour cells to antitumor activity of Nab-paclitaxel, due to its union through albumin-binding to this protein.
First-line clinical trials have been developed with different Nab-paclitaxel regimens and also in combination with different chemotherapies and trastuzumab, showing a high level of efficacy.
Toxicity profile of Nab-paclitaxel is well characterized with significantly less haematological toxicities compared with conventional paclitaxel.
Nab-paclitaxel derived grade III neuropathy is short-lasting and more reversible than conventional paclitaxel-derived neuropathy, probably due to absence of Cremophor solvent, or due to paclitaxel itself.
However there is still a lack of clinical and physiological characterisation of Nab-paclitaxel induced neuropathy.
The current used tools for early detection and continuous evaluation of neurotoxicity are not optimal. Most used toxicity scales are limited, as they do not provide a detailed information of the severity of the neuropathy, its impact on quality of life, or physiopathology mechanisms.
In addition, an inter-individual variability exists in terms of neurotoxicity predisposition when taxanes are used; it could be related to polymorphic differences in genes implicated in transport and metabolism of these drugs.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fundacion Oncosur is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Paclitaxel 80 mg/m2 days 1, 8 and 15
Drug: Paclitaxel 80 mg/m2
Nab-paclitaxel 100 mg/m2 days 1, 8 and 15
Drug: Nab-paclitaxel 100 mg/m2 days 1, 8 and 15
Nab-paclitaxel 150 mg/m2 days 1, 8 and 15
Drug: Nab-paclitaxel 150 mg/m2 days 1, 8 and 15
Nab-paclitaxel 150 mg/m2 days 1 and 15
Drug: Nab-paclitaxel 150 mg/m2 days 1 and 15
Paclitaxel 80 mg/m2 days 1, 8 and 15
Nab-paclitaxel 100 mg/m2 days 1, 8 and 15
Nab-paclitaxel 150 mg/m2 days 1, 8 and 15
Nab-paclitaxel 150 mg/m2 days 1 and 15
TNS - Total Neuropathy Score
Time frame: Every 3 months up to 6 months
Evaluate the incidence of neuropathy induced by study treatment (conventional paclitaxel vs nab-paclitaxel)
Time frame: Every 3 weeks up to 24 weeks
Evaluate the electromyographic abnormalities and the correlation of these alterations with the assessment of the TNS scale and NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0
Time frame: Every 12 weeks up to 24 weeks
Determine the predictive value of genetic variants (SNPs) for the development of neuropathy
Time frame: In the two weeks before start treatment
Determine the clinical activity of both treatments (response rate, time to progression)
Time frame: Every 8-12 weeks up to 24 weeks
Determine toxicity profile and safety of study treatments (NCI-CTCAE v4.0)
Time frame: Every 2 weeks up to 24 weeks
Determine time to neurotoxicity onset
Time frame: Every 2 weeks up to 24 weeks
Determine time to recovery from neurotoxicity
Time frame: Every 2 weeks up to 24 weeks
Determine time to progression
Time frame: Every 8-12 weeks up to 24 weeks
Assess quality of live (EORTC QLQ-C30 and EORTC QLQ-CIPN20)
Time frame: Every 4 weeks up to 24 weeks
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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