Trials / Completed
CompletedNCT04224922
Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
A Prospective, Belgian Multi-center, Single-arm, Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | |
| DRUG | Carboplatinum | |
| DRUG | Epirubicin | |
| DRUG | Cyclophosphamide |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2016-07-01
- Completion
- 2017-05-01
- First posted
- 2020-01-13
- Last updated
- 2020-01-18
Locations
18 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04224922. Inclusion in this directory is not an endorsement.