Trials / Completed
CompletedNCT01746225
Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- ETOP IBCSG Partners Foundation · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting. The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy. The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nab-Paclitaxel | Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations) |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2016-05-01
- Completion
- 2023-03-16
- First posted
- 2012-12-10
- Last updated
- 2023-06-01
- Results posted
- 2020-03-27
Locations
41 sites across 6 countries: Belgium, Ireland, Italy, Slovenia, Spain, Switzerland
Source: ClinicalTrials.gov record NCT01746225. Inclusion in this directory is not an endorsement.