Dynamic ctDNA Monitoring in Advanced Malignant Phyllodes Tumors of the Breast

Más betegség

• Presence of another active malignancy that may affect assessment of the study endpoints, except for cured carcinoma in situ, non-melanoma skin cancer, or a prior malignancy judged by the investigator not to affect study endpoint assessment.
• Severe active infection, severe cardiac, pulmonary, hepatic, or renal dysfunction, uncontrolled systemic disease, or any other clinical condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
• Inability to understand the study, provide informed consent, or comply with follow-up because of psychiatric, cognitive, social, or other factors.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.

Egyéb

• 1.Insufficient candidate somatic variants available for individualized tracking in the clinical WES results, or molecular data that do not meet the requirements for establishment of an individualized ctDNA monitoring panel.
• Pregnant or breastfeeding women.
• The current systemic treatment line has already started and baseline ctDNA blood collection could not be completed before initiation of that treatment line.

• Female patients aged 18 years or older.
• Pathologically confirmed malignant phyllodes tumor of the breast.
• Distant metastatic disease, or disease considered unsuitable for curative surgery based on multidisciplinary discussion or investigator assessment.
• Planning to start the current line of systemic therapy and able to complete baseline ctDNA blood collection and the required baseline assessments before initiation of that treatment line.
• At least one lesion available for imaging follow-up and assessment of disease progression.
• No prior tumor tissue whole-exome sequencing (WES), with WES independently determined by the treating physician to be clinically indicated based on the patient's own diagnostic and treatment needs; the patient must be able to undergo clinical WES and provide the resulting WES data and the necessary authorized molecular data required for establishment of an individualized ctDNA monitoring panel.
• Estimated life expectancy greater than 3 months, with clinical status considered adequate by the investigator to complete study-related blood collection, imaging assessments, and follow-up.
• The participant voluntarily agrees to participate in the study and provides written informed consent.