NCT05113251 · MORE INFO
Limitations, agreements, and source contact
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- certain Agreement
- pi Sponsor Employee
- false
- restrictive Agreement
- true
- limitations And Caveats
- description
- On 13 March 2024, enrolment to the T-DXd-alone arm was prematurely closed following the recommendation of the Independent Data Monitoring Committee (IDMC). Patients already receiving T-DXd alone could continue treatment until completion of eight cycles, meeting any discontinuation criteria, or switching to the investigator's choice of local SOC-classified as having a non-pCR.
- point Of Contact
- information.center@astrazeneca.com
- organization
- AstraZeneca Clinical Study Information Center
- phone
- 1-877-240-9479
- title
- Global Clinical Lead
Complete source fields
- certain Agreement
- pi Sponsor Employee
- false
- restrictive Agreement
- true
- limitations And Caveats
- description
- On 13 March 2024, enrolment to the T-DXd-alone arm was prematurely closed following the recommendation of the Independent Data Monitoring Committee (IDMC). Patients already receiving T-DXd alone could continue treatment until completion of eight cycles, meeting any discontinuation criteria, or switching to the investigator's choice of local SOC-classified as having a non-pCR.
- point Of Contact
- information.center@astrazeneca.com
- organization
- AstraZeneca Clinical Study Information Center
- phone
- 1-877-240-9479
- title
- Global Clinical Lead
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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