Trials / Completed
CompletedNCT02162667
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 562 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab | Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-05-26
- Completion
- 2018-10-01
- First posted
- 2014-06-13
- Last updated
- 2022-08-03
- Results posted
- 2019-10-29
Locations
98 sites across 22 countries: Argentina, Belarus, Bosnia and Herzegovina, Chile, France, Georgia, Hungary, India, Italy, Japan, Latvia, Mexico, Peru, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT02162667. Inclusion in this directory is not an endorsement.