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

Dornhofstr. 10
63263 Neu-Isenburg

Email: info@gbg.de

Tel.: +49 6102 7480-0

Recruiting

neoadjuvant

PREcoopERA (GBG 112)

The aim of this study is to investigate which of the three treatments (giredestrant, giredestrant with triptorelin, or anastrozole with triptorelin) best stops the division and growth of breast cancer cells in a short time window between diagnosis and surgery. We also want to find out whether the side effects of the study treatment are tolerable.

GeparPiPPa (GBG 105)

A randomized, open-label, phase II trial comparing neoadjuvant endocrine therapy in combination with trastuzumab, pertuzumab +/- the PI3K inhibitor inavolisib in patients with HER2-positive, HR-positive, PIK3CA mutant early breast cancer- GeparPiPPa

post-neoadjuvant

DESTINY Breast05 (GBG103)

T-DXd vs. T-DM1 in high risk HER2-positive patients with residual invasive breast cancer following neoadjuvant therapy
(DESTINY-Breast05; TruDy, NSABP B-60; GBG-03; SOLTI-2001. NCT04622319 )

operative

TAXIS (GBG 101)

Tailored AXIllary Surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS).
A multicenter randomized phase III trial.

Protocol SAKK 23/16 / IBCSG 57-18 / ABCSG-53, NCT03513614

EUBREAST-01 (GBG 104)

Omission of sentinel lymph node biopsy in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after neoadjuvant systemic therapy: a single-arm, prospective surgical trial.

adjuvant

Cambria-1 (GBG 110)

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

palliativ

Element (GBG 114)

Phase II study evaluating the addition of elacestrant, an oral selective estrogen receptor degrader (SERD), to niraparib, a PARP-inhibitor, compared to niraparib alone in patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with g/tBRCA1/2 and/or g/tPALB2 mutations

PADMA (GBG 93)

Evaluation of palbociclib plus endocrine treatment versus a chemotherapy-based treatment strategy in patients with hormone receptor positive / HER2 negative breast cancer in a real world setting.

Registry

Pregnancy (GBG 29)

Prospective and Retrospective Registry Study of the German Breast Group (GBG) for Diagnosis and Treatment of Breast Cancer in Pregnancy compared to young non-pregnant women (<40 years) as comparative cohort

ETERNITY-B registry (GBG 107)

Registry for long-term follow-up of safety and efficacy parameters of GBG study participants

BMBC (GBG 79)

Brain Metastases in Breast Cancer Network Germany

preventive

BRCA-P (GBG 106)

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation

Studies in planning

neoadjuvant

PREcoopERA (GBG 112)

adjuvant

Flamingo-01 (GBG 111)

A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy

Cambria-2 (GBG 115)

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety
of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs
Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for
Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of
Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence
of Disease

Studies in follow-up

neoadjuvant

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

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

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

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

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

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

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

GeparDouze (GBG 96)

NSABP B-59/GBG 96-GeparDouze

A clinical trial by NSABP Foundation , Inc. and German Breast Group (GBG)

E-Mail: gepardouze@gbg.de

post-neoadjuvant

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

SASCIA (GBG 102)

Phase III postneoadjuvant study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment - SASCIA

operative

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

PALLAS (GBG 87)

PALLAS: PALbociclib CoLlaborative Adjuvant Study

E-Mail: pallas@gbg.de

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

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

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

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

palliativ

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

AURORA (GBG 85)

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

E-Mail: aurora@gbg.de

Completed study

neoadjuvant

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.

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.

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)

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.

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

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

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

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

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

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

TAMENDOX (GBG 91)

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

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).

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.

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)

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)

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.

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.

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

ICE (GBG 32)

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

palliativ

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

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.

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.

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

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

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

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.

preventive

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.

Clinical Trials