EudraCT No.: 2011-005214-11
Status: recruitment in progress
An adjuvant phase III trial to compare intensified dose-dense therapy with epirubicin – nab-paclitaxel – cyclophosphamide (EnPC) vs. tailored dose-dense therapy (dtEC-dtD) in patients with early-stage high-risk breast cancer.
Amendment 2 has been in effect since 06/03/2013.
On 04/11/2015, patient recruitment figures to the GAIN-2 study reached 1,693. Many thanks to Dr. Seeger and Ms. Ballmann, St. Marienhospital Vechta.
On 22/10/2015, the number of patients recruited to the GAIN-2 trastuzumab s.c. substudy reached 117. Many thanks to Dr. Mahlberg and Hr. Marchand, Mutterhaus der Borromäerinnen, Trier.
GAIN-2 trastuzumab s.c. substudy
After completion of the GAIN-2 main study, HER2-positive patients will be eligible to participate in the trastuzumab subcutaneous substudy, in which antibodies are injected either into the abdominal wall or the thigh.
Please note that randomisation to the substudy is only possible once documentation has been completed for the main study. Moreover, the final trastuzumab infusion given during the GAIN-2 main study must be dosed at 6 mg kg/bw q3w. A subcutaneous injection of 600 mg trastuzumab q3w will then be administered during the substudy.
Trastuzumab will be administered for one year in total.
Please bring the trastuzumab s.c. substudy to the attention of your HER2-positive GAIN-2 patients. The aim is to recruit a total of 220 patients to the substudy. All GAIN-2 sites are eligible to take part.
An adjuvant phase III trial to compare intensified dose-dense therapy with epirubicin – nab-paclitaxel – cyclophosphamide (EnPC) vs. tailored dose-dense therapy with dd epirubin-cyclophosphamide-dd docetaxel (ddEC-ddD) in patients with early high-risk breast cancer.
The inclusion and exclusion criteria along with detailed information about the study design can be found in the protocol summary on the page headed “Documents”.
The most important trial-related documents can be downloaded here.
Registered sites can access further documents in the password-protected section of this website for internal use.
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