Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
NCT ID:
NCT00635050
Group ID:
EG000
Title:
Doxil, Paclitaxel, Cyclophosphamide + Avastin
Description:
Two staged phase II single arm trial to evaluate the pathologic complete response rate to sequential dose dense chemotherapy using Doxil, paclitaxel and cyclophosphamide with concurrent Avastin in patients with advanced invasive breast cancer.
Doxil, Paclitaxel, Cyclophosphamide, Avastin: Regimen A: Sequential Doxil 25 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/M 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 weeks will be given concurrently with all 3 agents. Patients who experience \<pCR to primary chemotherapy will receive an additional year of Avastin at the same dose equivalent beginning 6-8 weeks after definitive operation.
Regimen B: Sequential Doxil 30 mg/m2 every 2 weeks for 3 doses will be followed by paclitaxel 175 mg/m2 i.v. every 2 weeks for 3 doses, then by cyclophosphamide 600 mg/m 2 i.v. every 2 weeks for 3 doses. Avastin 10 mg/kg i.v. every 2 week
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
32
Other Number Affected:
23
Other Number At Risk:
32
Study:
NCT00635050
Results Section:
NCT00635050
Adverse Events Module:
NCT00635050