WHO ICTRP trial
A study to evaluate Efficacy and Safety of CT-P6 in HER2 Positive Early Breast…
CTRI/2014/11/005208 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2014/11/005208 |
|---|---|
| Public title | A study to evaluate Efficacy and Safety of CT-P6 in HER2 Positive Early Breast Cancer ( a type of breast cancer) |
| Scientific title | A Phase 3, Double Blind, Randomized, Parallel Group, Active Controlled Study to Compare the Efficacy and Safety of CT P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2 Positive Early Breast Cancer |
| Primary sponsor | CELLTRION Inc |
| Secondary sponsors | PPD Pharmaceutical Development India Private Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Argentina;Belarus;Brazil;Chile;France;Georgia;Greece;Hungary;India;Italy;Latvia;Mexico;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia ;Spain;Ukraine;Bosnia and… |
| Conditions | Health Condition 1: null- HER2-positive Carcinoma of Breast Health Condition 2: C50- Malignant neoplasm of breast Health Condition 3: C509- Malignant neoplasm of breast of unspecified site |
| Interventions | Intervention1: CT-P6 (trastuzumab): CT-P6 will be administered as IV infusion at 6mg/kg body weight after a loading dose of 8mg/kg body weight, upto 24 weeks (8 cycles) as neoadjuvant and upto 10 cycles as adjuvant treatment. Control… |
| Registration date | Nov 19, 2014 |
| Target size | 532 |
| Secondary IDs | 2013-004525-84;CT-P6 3.2 , Version 2.0, including Amendment 1 - 20 Jan 2014;NCT02162667 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: