Trastuzumab monotherapy followed by the combination of trastuzumab and letrozole in post-menopausal women with ER-positive, HER-2 positive advanced breast cancer resistant to a nonsteroidal aromatase inhibitor

Project

Trastuzumab monotherapy followed by the combination of trastuzumab and letrozole in post-menopausal women with ER-positive, HER-2 positive advanced breast cancer resistant to a nonsteroidal aromatase inhibitor

Automatically Closed · 2005 until 2011

Baumann Michael, Köberle Dieter

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Medizinische Onkologie und Hämatologie

Status

Automatically Closed

Start Date

2005

End Date

2011

Study Design

multicenter two-step phase II trial

Keywords

combination of trastuzumab and letrozole, post-menopausal women, ER-positive, HER-2 positive

Partner

Dr. med. Dieter Köberle Kantonsspital St. Gallen

Brief description/objective

The primary objective is to determine the efficacy of combined letrozole (L) and trastuzumab (T) in postmenopausal women with ER-positive, HER-2 positive advanced breast cancer resistant to sequential monotherapy of a nonsteroidal aromatase inhibitor followed by
trastuzumab.
The secondary objectives are to evaluate the safety profile of this combination by recording the adverse drug reactions and abnormal laboratory values during treatment and to investigate predictive markers for response to treatment with letrozole and trastuzumab in
HER-2 positive, ER-positive positive tumors.