What is being investigated in this study?

The SURVIVE study aims to compare standard aftercare with intensified aftercare in 3,500 patients with early-stage breast cancer. Patients in both groups will receive guideline-compliant aftercare, as they currently do from their treating (gynecologist) physician.

Additionally, both groups will have regular visits to the study center, where, in the intervention group, tumor traces in the blood will be sought using a so-called liquid biopsy. Various tumor markers, circulating tumor cells (CTCs), and circulating tumor DNA will be examined. If an abnormal result is found, imaging (computed tomography of the breast and abdomen, as well as bone scintigraphy) will be arranged for the patient to look for potential recurrences or distant metastases. The liquid biopsy will be supplemented by the regular collection of questionnaires on health status and quality of life.

In the standard aftercare group, blood samples will also be taken, but these will be stored for future research projects and not examined for now. Should abnormal results appear in a later analysis, you will, of course, be contacted.

Assignment to one of the two groups is random.

What is the goal of the study?

Primarily, the SURVIVE study investigates whether there is a difference in overall survival between the study groups and whether distant metastasis can be detected earlier through liquid biopsy. This long-awaited study could lead to a significant change in our current standard aftercare in the future.

What is the study procedure?

Within the study, there are two investigation groups, to which patients are randomly assigned in a 1:1 ratio:

Standard Arm:

Blood samples are regularly collected and stored in a so-called biobank for later (retrospective) analyses. Further imaging diagnostics are performed symptom-oriented according to current guidelines.

Intervention Arm:

The collected blood samples are examined for specific tumor markers, circulating tumor cells (CTCs), and circulating tumor DNA (ctDNA). Should an abnormal finding occur, further examination will be performed using computed tomography of the breast and abdomen (CT Thorax/Abdomen) and bone scintigraphy to rule out disease recurrence.

The visits are the same for both study groups:

• 2 baseline visits for data collection

thereafter

• every 3 months in years 1-3
• every 6 months in years 4-5

thereafter, annual contact (by phone, email, or study center visit) to complete a questionnaire on health status and quality of life, for 5 years.

Are there risks?

You will be informed about potential risks or side effects associated with participation during a detailed consultation.

Participation Requirements

Men and women between 18 and 75 years of age can participate in this study, with:

• Primary breast cancer with a moderate to high risk of recurrence
• First-line therapy (chemotherapy, surgery, or radiation therapy, whichever occurred last) completed a maximum of 24 months before study enrollment. Patients with luminal A/B breast cancer (hormone receptor+, HER2-/low) can participate up to 60 months after completion of primary therapy.
• No evidence of distant metastasis

In addition, there are other criteria that must be met for participation in the study. Interested patients should speak with the study physicians at a study center to determine if this study is suitable for them.

Where can I participate in this study?

Further information about the study and participating centers can be found at:
https://www.survive-studie.de/patienten.html

The study is conducted by: