drugset / Trial / NCT00004935
Herceptin Followed by Chemotherapy in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
RandomizedFactorialOpen-labelTreatment
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 advanced/metastatic breast cancer. PURPOSE: Trial SAKK 22/99 addresses clinically relevant and currently unresolved questions regarding the optimal use of Herceptin in the treatment of patients with advanced/metastatic breast cancer.
Timeline
- Start
- 1999-08-30
- Primary completion
- 2014-11-06
- Completion
- 2022-03-31
Publications
- Eppenberger-Castori S, Klingbiel D, Ruhstaller T, Dietrich D, Rufle DA, Rothgiesser K, Pagani O, Thurlimann B. Plasma HER2ECD a promising test for patient prognosis and prediction of response in HER2 positive breast cancer: results of a randomized study - SAKK 22/99. BMC Cancer. 2020 Feb 11;20(1):114. doi: 10.1186/s12885-020-6594-0.
- Schmid S, Klingbiel D, Aebi S, Goldhirsch A, Mamot C, Munzone E, Nole F, Oehlschlegel C, Pagani O, Pestalozzi B, Rochlitz C, Thurlimann B, von Moos R, Weder P, Zaman K, Ruhstaller T. Long-term responders to trastuzumab monotherapy in first-line HER-2+ advanced breast cancer: characteristics and survival data. BMC Cancer. 2019 Sep 10;19(1):902. doi: 10.1186/s12885-019-6105-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |