GBG Forschungs GmbH is an independent, impartial academic research organisation (ARO). Unlike contract research organisations (CRO), we do not provide research services purely on a contract basis. All study projects have to address an academic question which meets the requirements of the German Breast Group. Through our research, we aim to continually improve the treatment of breast cancer and the quality of the therapy available on a global basis.
When conducting our breast cancer research projects, we adhere to the principles of international academic study groups. Our research institute, together with the German Breast Group’s sub-boards, creates the protocols for our studies as well as our databases and is also responsible for their evaluation and publication – always without influence from the pharmaceutical industry. Examples of our research are the neoadjuvant studies belonging to the “Gepar” trial series.
Today, GBG Forschungs GmbH has clinical data from more than 55,000 breast cancer patients at its disposal. Thanks to our expertise and experience acquired through 30 years of research, we are one of the world’s leading breast cancer research institutes.
Our research projects are funded in advance via clinical trials, donations, public funding, the German Cancer Aid Organisation (Deutsche Krebshilfe) and the German Research Foundation (Deutsche Forschungsgemeinschaft). In addition, we receive funding from the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung ─ BMBF) and from foundations, such as the Banss-Stiftung, the Walter-Schulz-Stiftung and the Claudia-von-Schilling-Stiftung, as well as cooperation partners from the pharmaceutical industry. Our Translational Research Division is predominantly funded by the EU, the German Federal Government and various foundations.
Overview of our currently recruiting trials. Further studies are in planning.
Operable node-positive breast cancer:
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:
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.
Operable triple-negative breast cancer:
Arm A: Adjuvant chemotherapy with 12x paclitaxel weekly followed by EC/AC q2w + atezolizumab q2w followed by atezolizumab monotherapy q3w (total duration of atezolizumab will be one year)
Arm B: Chemotherapy alone
Operable HR-positive / HER2-negative breast cancer:
Arm A: Palbociclib 2 years + standard adjuvant endocrine therapy ≥ 5 years
Arm B: Adjuvant chemotherapy followed by standard adjuvant endocrine therapy ≥ 5 years
HER2-negative breast cancer, non-pCR after NACT
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
Arm A: Trastuzumab deruxtecan 14 cycles d1 q3w
Arm B: Trastuzumab emtansine (T-DM1) 14 cycles d1 q3w
HER2-positive, HR-positive breast cancer
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)
Brain metastases of breast cancer
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 and HR-positive metastatic breast cancer :
Endocrine therapy + palbociclib versus mono-chemotherapy +/- endocrine maintenance therapy
Possible mono-chemotherapies (Physician`s choice):
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
Former GBG study participants in Germany
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 QI-II/2022