Ignite Creation Date:
2024-05-06 @ 12:47 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01658462
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2012-07-31
Brief Title:
Phase II Study of Docetaxel - Nintedanib in Breast Cancer
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB BIBF-1120 in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAROCE-1206
Brief Summary:
National randomized unblinded phase IIb trial with 2 strata First-line chemotherapy Second-line chemotherapy for locally recurrent or metastatic breast cancer
Detailed Description:
Patients will be stratified at randomization according to first-line chemotherapy Second-line chemotherapy for metastatic or locally recurrent breast cancer
Treatment until progression or unacceptable toxicity Visits are planned every 3 weeks during treatment and every 3 months after end of treatment or patients withdrawal
Treatment until progression or unacceptable toxicity Visits are planned every 3 weeks during treatment and every 3 months after end of treatment or patients withdrawal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-002214-38 | EUDRACT_NUMBER | None | None |