Trials / Completed
CompletedNCT02783222
EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly With advanCed breasT Cancer
EFFECT: A Randomized Phase II Study to Evaluate the EFficacy and Impact on Function of Two Different Doses of Nab-paclitaxEl in Elderly Patients With advanCed breasT Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Fondazione Sandro Pitigliani · Academic / Other
- Sex
- Female
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized study evaluating the efficacy and impact on function of two different doses of nab-Paclitaxel in elderly patients with advanced breast cancer.
Detailed description
This open-label, randomized phase II trial evaluates in parallel two doses of nab-Paclitaxel (100 and 125mg/m2) given weekly for 3 weeks every 28 days, in elderly women aged 65 years or older, as first line treatment for advanced breast cancer (locally recurrent or metastatic). A short geriatric evaluation of co-morbidity and functional status will be performed before study entry. The functional status will be monitored at baseline and at every cycles during treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nab-paclitaxel | comparison of different dosages of drug |
Timeline
- Start date
- 2013-01-30
- Primary completion
- 2017-09-22
- Completion
- 2017-12-01
- First posted
- 2016-05-26
- Last updated
- 2018-01-10
Locations
14 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02783222. Inclusion in this directory is not an endorsement.