C50
Conditions
Interventions
Group 1: The study will collect clinical data on patients with early breast cancer and residual disease after NACT, and at the time of relapse as well as on patients with metastatic breast cancer. Lon
Sponsors
GBG Forschungs GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with eBC and clinically gross residual tumor after NACT or distant recurrence of breast cancer during/after (neo-)adjuvant therapy or mBC with progression after at least one line of therapy for mBC. 2. All patients must be able to provide a pair of longitudinal tissue samples namely: • one sample before NACT and one sample after NACT for patients with eBC • one sample before and one sample after disease progression occurred for patients with mBC 3. Female and male breast cancer patients aged = 18. 4. Participation is allowed independently of breast cancer histology (ductal, lobular, others) and of breast cancer subtype (Luminal A, luminal B, HER2-positive, triple-negative) but will focus on high-risk tumors such as TNBC and luminal B. 5. Informed consent for data collection and biomaterial collection. 6. Participation in other interventional clinical trials is allowed.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of any malignancy beside breast cancer are ineligible with the following exceptions: a. Disease-free for at least 5 years (last assessment must have been performed within 3 months before inclusion) and the features of the primary tumor are considered low risk. b. CIS of the cervix, basal cell and squamous cell carcinomas of the skin. 2. Patients with no histological verification of the diagnosis of breast cancer. 3. Patients with eBC or de novo mBC that have not received any systemic therapy. 4. Tissue acquirement either by biopsy or during surgery not possible. 5. Any physical or mental condition or severe comorbidities that would compromise the adequate cooperation of the patient. 6. History of significant neurological or psychiatric disorders that would prohibit the understanding of the study purpose and giving of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess tumor heterogeneity by analyzing longitudinal tumor samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To define biomarkers to predict resistance to systemic therapy, in the neoadjuvant, adjuvant and metastatic setting. 3. To describe the change in breast cancer subtype and in molecular markers after systemic therapy. 4. To identify new prognostic biomarkers associated with worse long-term outcome (e. g. disease-free, progression-free and overall survival). 5. To identify possible markers predictive for tumor sensitivity for post-neoadjuvant and palliative systemic therapies. 6. To identify new druggable targets which could be investigated for post-neoadjuvant and palliative treatment | — |
Countries
Germany
Contacts
Public ContactSibylle Loibl
GBG Forschungs GmbH
Outcome results
None listed