Trials / Completed
CompletedNCT02135159
Patients With Brain Metastases From HER2-positive Breast Cancer
A Phase I Study to Evaluate the Feasibility of Different Sequences of Combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy in Patients With Brain Metastases From HER2-positive Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.
Detailed description
Determine the best sequences.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TDM1 | administration of the TDM1 by IV perfusion |
| RADIATION | Brain Sequential RT | local RT |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2017-02-01
- Completion
- 2017-03-01
- First posted
- 2014-05-09
- Last updated
- 2017-08-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02135159. Inclusion in this directory is not an endorsement.