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Studien der German Breast Group

Die Studiengruppe German Breast Group und die GBG Forschungs GmbH arbeiten gemeinsam daran, die Brustkrebs (Mammakarzinom)-Behandlung kontinuierlich zu verbessern und die Therapiequalität flächendeckend anzuheben. Um dieses Ziel zu erreichen, forschen wir in akademisch orientierten klinischen Studien. Dabei kooperieren wir eng mit forschenden Pharmafirmen und kombinieren die modernsten Wirkstoffe – für die wirksamsten Therapieempfehlungen.

Gut zu wissen: In den Studienmenus finden Sie jeweils auf der rechten Seite Ihren Ansprechpartner!

Umsetzung von Studien der Phasen I bis IV

Als unabhängiges akademisches Forschungsinstitut setzen wir klinische Studien der Phasen I bis IV um. Unser Forschungsbereich umfasst dabei die neoadjuvante medikamentöse und die operative Therapiephase sowie die postoperative adjuvante und die chronisch-palliative Therapiephase.

Im Studienbereich der Webseite finden Sie laufende Studien sowie Studien, die sich im Follow-up, der Nachuntersuchung, befinden. Zusätzlich können Sie im Studien-Archiv bereits abgeschlossene Untersuchungen einsehen.

GBG Study Finder 2023

Overview of our currently recruiting trials. Further studies are in planning.

Early Breast Cancer

Operative Studies (M0)

Operable node-positive breast cancer:

  • Most suspicious lymph node clipped
  • AJCC/UICC stage II-III
  • Eligible for primary axillary lymph node dissection or sentinel lymph node biopsy procedure

Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy. All patients will receive breast/chest wall and regional nodal irradiation. Patients without axillary lymph node dissection will receive additional irradiation of the axilla.


Operable HER2-positive or triple-negative breast cancer:

  • cT1c-T3 prior to neoadjuvant systemic therapy (NAST) and
  • cN0/iN0
  • Standard NAST with radiological complete response

Omission of sentinel lymph node biopsy in patients with radiologic and pathologic complete response in the breast after neoadjuvant systemic therapy. All patients with confirmed breast pCR after lumpectomy will be selected for the single study arm leading to omission of any axillary treatment.


Neoadjuvant Studies (M0)

HER2-positive, HR-positive breast cancer

  • cT1c-T3 prior to neoadjuvant treatment
  • Centrally confirmed PIK3CA mutation (tumor)
  • BMI ≤ 30

GBG105 - GeparPiPPa
Arm A: Endocrine therapy in combination with ready-to-use fixed-dose combination of pertuzumab and trastuzumab s.c. (PH-FDC SC) q3w and inavolisib (6 cycles)
Arm B: Endocrine therapy and PH-FDC SC q3w (6 cycles)


Post-neoadjuvant Studies (M0)

HER2-negative breast cancer, non-pCR after NACT

  • HR-negative (TNBC)


  • HR-positive with CPS-EG score ≥3 or 2 and ypN+
  •  At least 16 weeks of taxane-based chemotherapy

Arm A: Sacituzumab govitecan 8 cycles d1,8 q3w
Arm B: Treatment of physician`s choice (8 cycles capecitabine or platinum-based chemotherapy or observation)
In patients with HR-positive breast cancer, endocrine therapy will be administered according to local guidelines.


HER2-positive breast cancer, non-pCR after NACT

  • cT4, cN0-3 or cT1-3, cN2-3 at first diagnosis


  • cT1-3, cN0-1 at first diagnosis with ypN1-3 after NACT
  • An interval of ≤12 weeks between the date of last surgery and the date of randomization
  • At least 16 weeks chemotherapy, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane-based chemotherapy

GBG103 - TruDy/DESTINY-B05
Arm A: Trastuzumab deruxtecan 14 cycles d1 q3w
Arm B: Trastuzumab emtansine (T-DM1) 14 cycles d1 q3w


Adjuvant Studies (M0)

HR-positive / HER2-negative breast cancer:

  • Intermediate/high risk of relapse
  • 2 - 5 years endocrine therapy (ET) Adequate surgical and systemic pretreatment
GBG 110 – CAMBRIA-1 *
Arm A: Camizestrant 150mg 1x1/d over 5 years with or without LHRH agonist
Arm B: Continue the standard ET of investigator’s choice (AI or tamoxifen with or without LHRH agonist)

HER2-positive breast cancer:
  • Stage I, II or III prior to neoadjuvant treatment and non-pCR or Stage III and pCR
  • Neoadjuvant chemotherapy (CT) with at least 4 cycles of a taxane-based CT and anti-HER2 therapy
  • Start of study treatment within 90 days after completion of adjuvant trastuzumab

GBG 111 – Flamingo-01 *

HLA-A*02 subjects will be randomized to GLSI-100 or placebo:
Arm A: 11 intradermal doses of placebo (NaCl 0.9%) over 3 years
Arm B: 11 intradermal doses of GLSI-100 (blinded) over 3 years

A third open-label arm will explore GLSI-100 in non-HLA-A*02 positive patients (11 intradermal doses of GLSI-100 over 3 years)


Metastatic Breast Cancer

All subtypes

Brain metastases of breast cancer

GBG79 - Brain Metastases in Breast Cancer (BMBC)
Retrospective and prospective registry designed to collect tumor characteristics of the primary and metastatic tumor as well as treatment data and biomaterial from patients diagnosed with brain metastases of breast cancer.


HER2-negative Breast Cancer

HER2-negative and HR-positive metastatic breast cancer :

  • 1st systemic therapy for the treatment of metastatic breast cancer
  • Patients with only asymptomatic oligometastases of the bone as the only site of metastatic disease are excluded

Endocrine therapy + palbociclib versus mono-chemotherapy +/- endocrine maintenance therapy
Possible mono-chemotherapies (Physician`s choice):

  • Capecitabine p.o.
  • Epirubicin i.v.
  • Paclitaxel i.v.
  • Vinorelbine i.v.

Breast Cancer in Special Situations

Pregnancy and Young Women

  • Patients with breast cancer during pregnancy
  • Non-pregnant women with breast cancer < 40 years
  • M1 possible

Prospective and retrospective registry study for the diagnosis and treatment of breast cancer in pregnancy compared to young non-pregnant women.



  • Women with a confirmed or likely deleterious BRCA1 germline mutation
  • Age ≥ 25 years and ≤ 55 years
  • No evidence of breast cancer
    No preventive breast surgery planned
  • No previous history of breast or ovarian cancer

GBG106 - BRCA-P *

Study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germline mutation:
Denosumab 120mg s.c. every 6 months vs placebo s.c. every 6 months



Long-term Safety and Efficacy

  • Former GBG study participants in Germany

GBG71 - Patient self-reported outcome registry (PSRO)
Collection of long-term safety and efficacy parameters of former GBG study participants from prospective clinical trials. Data reporting by the patient via questionnaire.

  • Former GBG study participants other countries

Registry for collection of long-term safety and efficacy parameters of former GBG study participants from prospective clinical trials. Data collection and documentation is performed study site.


* Planned start of recruitment QII-III/2023

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