Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004935
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2000-03-07
Brief Title:
Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Randomized Phase III Trial of Herceptin Followed by Chemotherapy Plus Herceptin Versus the Combination of Herceptin and Chemotherapy as Palliative Treatment in Patients With HER2- Overexpressing AdvancedMetastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial is Life long follow-up to reduce ressources and costs - trial terminated prematurely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE To compare efficacy toxicity and quality of life of the sequential administration of Her alone followed at PD by the combination with Chemotherapy Arm A vs the upfront combination of Her and Chemotherapy Arm B in patients with advancedmetastatic breast cancer
PURPOSE Trial SAKK 2299 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advancedmetastatic breast cancer
PURPOSE Trial SAKK 2299 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advancedmetastatic breast cancer
Detailed Description:
In advanced HER2 breast cancer the impact of combining Trastuzumab T and chemotherapy chemo versus T alone followed by the addition of chemo at disease progression has not been properly studied
The trial compared efficacy toxicity and quality of life of sequential administration of T followed at progression by combination with chemo TTChemo versus the upfront combination of T and chemo TChemo in patients with HER2 advanced breast cancer
The trial compared efficacy toxicity and quality of life of sequential administration of T followed at progression by combination with chemo TTChemo versus the upfront combination of T and chemo TChemo in patients with HER2 advanced breast cancer
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 |
|---|---|---|---|
| EU-99028 | OTHER | SAKK | None |
| SWS-SAKK-2299 | OTHER | None | None |