German Breast Group (GBG)
Authors:   The Breast International Group
Published: April 2007

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by German Breast Group (GBG). Clinical trials include:

A multi-center randomized Phase III study evaluating 4 cycles of docetaxel, doxorubicin and cyclophosphamide (TAC) versus 4 cycles of vinorelbine and capecitabine (NX) in patients not sufficiently responding to 2 cycles of TAC and 4 cycles of TAC versus 6 cycles of TAC in patients sufficiently responding to 2 cycles of TAC as preoperative treatment of locally advanced (T4 a-d, N0-3,M0) or operable (T ≥ 2 cm, N0-2,M0) primary breast cancer/GBG 24.

A multi-center randomized Phase III study to compare capecitabine alone or in combination with trastuzumab in patients with HER-2 positive metastatic breast cancer and progression after previous treatment with trastuzumab (Treatment Beyond Progression, TBP). BIG 3-05-GBG26

A Phase III multi-centre double blind randomized trial of celecoxib versus placebo in primary breast cancer patients. BIG 1-03-ICCG/C/20/01 - GBG27 (see also description under ICCG)

Prospective Register Study of the German Adjuvant Breast Cancer Study Group (GABG) or Diagnosis and Treatment of Breast Cancer in Pregnancy / BIG 2–03, GBG 29.

Ibandronate with or without capecitabine in elderly patients with early breast cancer – ICE – Study / BIG 4-04, GBG 32. (see also description under WSG)

GAIN: German Adjuvant Intergroup Node-positive Study. A Phase III trial to compare ETC versus EC-TX and ibandronate versus observation in patients with node-positive primary breast cancer / GBG 33.

A randomized, multi-center, open Phase III study comparing the postoperative use of zoledronic acid versus no treatment in patients with histological tumour residuals after preoperative anthracycline and taxane-containing chemotherapy for primary breast cancer (Neo-Adjuvant Trial Add-On) / GBG 36.

Prospective randomized multi-center study to prevent chemotherapy-induced ovarian failure with the GnRH-agonist goserelin in young hormone-insensitive breast cancer patients receiving anthracycline-containing (neo-)adjuvant chemotherapy / GBG 37, ZORO-Study

A multi-centre Phase I–II study to investigate the combination of bendamustine with weekly paclitaxel as first or second line therapy in patients with anthracycline-pretreated metastatic breast cancer / GBG 38, Rita – Study.

A multi-center Phase II study to determine the efficacy of capecitabine as first line monochemotherapy in patients with HER-2 negative metastatic breast cancer / GBG 39, Monica – Study.

GeparQuattro: A randomized Phase III study exploring the efficacy of capecitabine given concomitantly or in sequence to EC – Doc with or without trastuzumab as neoadjuvant treatment of primary breast cancer. A joint study of GBG and AGO / GBG 40.

Randomized study comparing 6 × FEC with 3 × FEC followed by 3 × docetaxel in high-risk node-negative patients with operable breast cancer: comparison of efficacy and evaluation of clinico-pathological and biochemical markers as risk selection criteria. A joint study of AGO, the EORTC Receptor and Biomarker Group, and the GBG (GBG 42 / NNBC 3-Europe).