Molecular mechanisms of therapy resistant breast cancer - MOMENTUM (GBG 108)

GBG Forschungs GmbH0 个研究点目标入组 2,000 人开始时间: 2024年4月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

•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.

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