Healing through innovation, expertise and partnership

Clinical Trials

Since foundation of GBG, we have worked with 800 study centres around the world and centres around the world and have treated more than 67,000 patients in > 115 studies.

We are researching breast cancer treatment in academic phase II to IV clinical trials. 
phase II to IV clinical trials. The hypotheses for potential trials are  potential studies are developed in regular meetings with the sub-board members. This means that at the end of an exchange between our independent, external clinical experts an idea is developed which is then investigated in studies. These These study concepts are planned, made publicly available and quality standards, made publicly accessible and carried out in order to transparency about compliance with the standards at all times.To this end, we also cooperate closely with research-based pharmaceutical manufacturers and combine state-of-the-art therapy options in order to find the best treatment recommendations.

Our research area includes the following forms of therapy or types of treatment: 

  • Pre-operative (neoadjuvant) drug therapy 
  • local therapy (surgery & radiotherapy) 
  • post-operative (adjuvant) therapy
  • Drug therapy for chronic breast cancer 
  • Prevention 
GBG Forschungs GmbH

Dornhofstr. 10
63263 Neu-Isenburg

 

Tel.: +49 6102 7480-0
Which studies are you looking for?
Neoadjuvant Therapy Studies
GeparOLA (GBG 90)

A randomized phase II trial to assess the efficacy of paclitaxel and olaparib in comparison to paclitaxel / carboplatin followed by epirubicin/cyclophosphamide as neoadjuvant chemotherapy in patients with HER2-negative early breast cancer and Homologous Recombination Deficiency (HRD patients with deleterious BRCA1/2 tumor or germline mutation and/or HRD score high) (GeparOLA)

 

E-Mail: geparola@gbg.de

Neoadjuvant Therapy Studies
GeparX (GBG 88)

Investigating Denosumab as an add on to neoadjuvant chemotherapy in RANK/L positive or RANK/L negative primary breast cancer and two different nab Paclitaxel schedules in a 2x2 factorial design

 

E-Mail: geparx@gbg.de

Neoadjuvant Therapy Studies
GeparSixto (GBG 66)

A randomized phase II trial investigating the addition of carboplatin to neoadjuvant therapy for triple-negative and HER2-positive early breast cancer (GeparSixto)

 

E-Mail: geparsixto@gbg.de

Neoadjuvant Therapy Studies
GeparSepto (GBG 69)

To compare the pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.

 

E-Mail: geparsepto@gbg.de

Neoadjuvant Therapy Studies
GeparOcto (GBG 84)

A randomized phase III trial comparing two dose-dense, dose-intensified approaches (ETC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer.

 

E-Mail: geparocto@gbg.de

Neoadjuvant Therapy Studies
GeparNuevo (GBG 89)

A randomized phase II study to investigate the addition of PD L1 antibody MEDI4736 to a taxane anthracycline containing chemotherapy in triple negative breast cancer (TNBC).

 

E-Mail: geparnuevo@gbg.de

Neoadjuvant Therapy Studies
DAFNE (GBG 70)

A phase II study investigating dual HER2 blockade with Afatinib and Trastuzumab in combination with neoadjuvant chemotherapy in patients with HER2-positive primary breast cancer.

 

E-Mail: dafne@gbg.de

Post-Neoadjuvant Studies
Penelope (GBG 78)

Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptorpositive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy.
The GBG Forschungs GmbH is conducting the study in cooperation with the AGO-B, the Breast International Group (BIG) and the NSABP Foundation.

 

E-Mail: penelope@gbg.de

Operative Therapy Studies
Insema (GBG 75)

Comparison of axillary sentinel lymph node biopsy versus no axillary surgery in patients with early-stage invasive breast cancer and breastconserving surgery: a randomized prospective surgical trial.

 

E-Mail: insema@gbg.de

Adjuvant Therapy Studies
PALLAS (GBG 87)

PALLAS: PALbociclib CoLlaborative Adjuvant Study

 

E-Mail: pallas@gbg.de

 

Adjuvant Therapy Studies
OlympiA (GBG 82)

Olaparib as adjuvant Treatment in patients with BRCA1/2 mutations and high risk HER2 negative primary breast cancer

 

E-Mail: olympia@gbg.de

Adjuvant Therapy Studies
APPALACHES (GBG 100)

A Phase II study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS with high-risk ER+/HER2- early breast cancer (APPALACHES)

E-Mail: appalaches@gbg.de

Adjuvant Therapy Studies
GAIN-2 (GBG 68)

Neo- / adjuvant phase III trial to compare intense dose-dense chemotherapy to tailored dose-dense chemotherapy in patients with high risk early breast cancer.

 

E-Mail: gain2@gbg.de

Adjuvant Therapy Studies
GAIN (GBG 33)

A multicentric phase III trial to compare ETC vs. EC-TX and Ibandronate vs. observation in patients with node-positive primary breast cancer

 

E-Mail: gain@gbg.de

Palliative Therapy Studies
PATINA (GBG 94)

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

 

E-Mail: patina@gbg.de

Palliative Therapy Studies
AURORA (GBG 85)

AURORA (GBG 85): Molecular aberrationen in metastastatic breast cancer

E-Mail: aurora@gbg.de

Neoadjuvant Therapy Studies
NeoPHOEBE (GBG 73)

A phase II, randomized, parallel cohort, two stage, doubleblind, placebo-controlled study of neoadjuvant trastuzumab versus trastuzumab + BKM120 in combination with weekly paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer.

 

Neoadjuvant Therapy Studies
GeparTrio (GBG 24)

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 ad, N0-3,M0) or operable (T ³ 2cm, N0-2,M0) primary breast cancer.

 

Neoadjuvant Therapy Studies
GeparQuinto (GBG 44)

A PHASE III TRIALS PROGRAM EXPLORING THE INTEGRATION OF BEVACIZUMAB, EVEROLIMUS (RAD001), OR LAPATINIB INTO CURRENT NEOADJUVANT CHEMOTHERAPY REGIMES FOR PRIMARY BREAST CANCER.

A joint study of the AGO Breast and the German Breast Group (GBG)

Neoadjuvant Therapy Studies
GeparQuattro (GBG 40)

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.

 

Neoadjuvant Therapy Studies
Genevieve (GBG 74)

A randomized, open-label, phase II study comparing the efficacy and the safety of cabazitaxel versus weekly paclitaxel given as neo-adjuvant treatment in patients with operable Triple Negative or luminal B/HER2 normal Breast Cancer

Post-Neoadjuvant Studies
NATAN (GBG 36)

A randomized, multicenter, open phase III study comparing the postoperative use of zoledronic acid versus no treatment in patients with histological tumor residuals after preoperative anthracycline and taxane containing chemotherapy for primary breast cancer

Operative Therapy Studies
Senszi (GBG 80)

A randomized, controlled, multicenter, surgical study to evaluate the role of preoperative lymphoscintigraphy prior to axillary sentinel lymphadenectomy in primary breast cancer

Adjuvant Therapy Studies
MALE (GBG 54)

A PROSPECTIVE, RANDOMISED MULTI-CENTRE PHASE II STUDY EVALUATING THE ADJUVANT, NEOADJUVANT OR PALLIATIVE TREATMENT WITH TAMOXIFEN +/- GnRH ANALOGUE VERSUS AROMATASE INHIBITOR + GnRH ANALOGUE IN MALE BREAST CANCER PATIENTS

Adjuvant Therapy Studies
ZORO (GBG 37)

Randomized Phase II 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

Adjuvant Therapy Studies
TEXT (GBG 57)

A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

Adjuvant Therapy Studies
TAMENDOX (GBG 91)

Genotype and phenotype guided supplementation of TAMoxifen Standard therapy with the active Metabolite ENDOXifen in breast Cancer patients.

Adjuvant Therapy Studies
SOLE (GBG 59)

A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer.

 

The study is being conducted in cooperation with the IBCSG (INTERNATIONAL BREAST CANCER STUDY GROUP).

Adjuvant Therapy Studies
SOFT (GBG 56)

Open-label, randomized, multicenter, phase III study to evaluate the role of ovarian function suppression and the role of the drug exemestane as a preventive therapy for premenopausal women who may respond to hormonal therapies.

Adjuvant Therapy Studies
REACT Celecoxib vs. Placebo (GBG 27)

A PHASE III MULTICENTRE DOUBLE BLIND RANDOMISED TRIAL OF CELECOXIB VERSUS PLACEBO IN PRIMARY BREAST CANCER PATIENTS (REACT – RANDOMISED EUROPEAN CELECOXIB TRIAL)

Adjuvant Therapy Studies
PANTHER (GBG 53)

A randomized phase III study: Comparing biweekly and tailored epirubicin + cyclophosphamide followed by biweekly tailored docetaxel (dtEC→dtT) with three weekly epirubicin + cyclophosphamide, 5-fluorouracil followed by docetaxel(FEC→T)

Adjuvant Therapy Studies
NNBC-3 (GBG 42)

Randomized study comparing 6 x FEC with 3 x FEC followed by 3 x 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, GBG and the EORTC Receptor and Biomarker Group.

 

Adjuvant Therapy Studies
IBIS-II DCIS (GBG 34)

Prevention in DCIS (IBIS-II-DCIS): a randomised double blind control trial which will compare tamoxifen versus anastrozole in women with locally excised ER or PgR positive Ductal Carcinoma In-Situ (ER or PGR+ve DCIS) in terms of disease-free survival and adverse event profiles.

 

Adjuvant Therapy Studies
ICE II (GBG 52)

An investigational randomized phase II-(III) study on epirubicin plus cyclophospamide (or CMF) vs. nab-paclitaxel plus capecitabine as adjuvant chemotherapy for elderly non frail patients with an increased risk for relapse of a primary carcinoma of the breast

 

Adjuvant Therapy Studies
ICE (GBG 32)

A clinical trial to investigate the effect of ibandronate with and without capecitabine on breast cancer in elderly patients

Palliative Therapy Studies
TIFFANY (GBG 65)

A multicenter non-randomized phase II study to evaluate nab-paclitaxel in metastatic breast cancer patients failing a solvent based taxane as (neo-)adjuvant treatment

Palliative Therapy Studies
TABEA (GBG 43)

A randomized phase III study to determine the efficacy of a taxane and bevacizumab with or without capecitabine as first line chemotherapy in patients with metastatic breast cancer.

 

NCT 01200212

The TABEA study was awarded the A seal of approval by the German Cancer Society.

Palliative Therapy Studies
AMICA (GBG 97)

Anti-hormonal maintenance treatment with the CDK4/6 inhibitor Ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial.

 

Palliative Therapy Studies
LEA (GBG 51)

MULTICENTER, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH ENDOCRINE TREATMENT COMPARED TO ENDOCRINE TREATMENT ALONE, IN POSTMENOPAUSAL WOMEN WITH ADVANCED OR METASTATIC BREAST CANCER WITH INDICATION OF HORMONOTHERAPY AS FIRST-LINE TREATMENT

 

Palliative Therapy Studies
EVELYN (GBG 76)

A multicenter randomized, double blind, placebo controlled, phase III study to compare endocrine treatment alone versus endocrine treatment with everolimus in patients with HR+/HER2 metastatic breast cancer and progression after previous treatment with exemestane and everolimus

Palliative Therapy Studies
E-Vita (GBG 76)

A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in patients pre-treated with anti-HER2- therapy with HER2-positive metastatic breast cancer

 

Palliative Therapy Studies
DESIREE (GBG 86)

DESIREE - A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer.

 

IBIS II Prevention (GBG 28)

Prevention in women with high risk (IBIS-II-Prevention): a randomised double blind control trial comparing anastrozole vs placebo in women with high risk breast cancer.

IBIS-II is designed to continue the work started in IBIS-I in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS-I was set up to investigate the use of tamoxifen as a preventive agent for women with moderate to increased risk of getting breast cancer.