Comparing standard and intensive surveillance for early breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to evaluate the benefits of intensified surveillance compared to standard surveillance in patients with medium-risk and high-risk early breast cancer. It involves a partially double-blinded, multi-center, randomized, controlled design with 3500 participants who will be enrolled after completing primary anti-tumor therapy. Participants will be randomly assigned to either the Standard Surveillance arm, which follows national guidelines, or the Intensive Surveillance arm, which includes additional blood tests for tumor markers and ctDNA. The study will assess overall survival rates and the lead time effect of intensive surveillance in detecting potential metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
2. Unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically.
3. Patients with intermediate- to high-risk early breast cancer defined as either

   * an indication for (neo-)adjuvant chemotherapy (regardless whether performed or not), and/or
   * Large tumor (\> 50 mm), and/or
   * Positive lymph nodes, and/or
   * High grade (\>= G3). Indication to (neo-)adjuvant chemotherapy is seen as stated in the German S3 guideline for breast cancer as well as stated in the guidelines from the AGO.
4. A complete resection of the primary tumor, with resection margins free of invasive carcinoma.
5. Completion of primary anti-tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever occurs last) at least 4 weeks but no more than 24 months previously. Enrollment of patients during any kind of adjuvant therapy except chemotherapy (e.g., but not limited to endocrine therapy, antibody therapy, CDK4/6-inhibitors, PARP inhibitors, PI3K inhibitors, antibody-drug conjugates and other novel agents) is allowed.
6. Availability of primary tumor tissue from core biopsy or surgical removed tissue (FFPE Slide (≥ 6 mm³, min. 10 slides, thickness: 5 µm-10 µm, area \>150 mm² and 1 H\&E stained slide, minimum 20% tumor content) or FFPE Block (≥ 6 mm³ thickness: 100 µm, area: \>150 mm² and 1 H\&E stained slide, minimum 20% tumor content) or Genomic DNA extracted from FFPE slides or block (≥ 600 ng, Minimum volume: 25 µL, concentration: 20 ng/µL, buffer: 10 mM Tris pH 8, 1 mM EDTA)) at timepoint of enrollment.

   * Patients with primary systemic therapy: tissue from core biopsy
   * Patients receiving surgery as primary therapy: surgically removed cancer tissue.
7. No current clinical evidence for distant metastases.
8. Females or males ≥ 18 years and ≤ 75 years of age.
9. Performance status ≤ 1, Eastern Cooperative Oncology Group (ECOG) scale.
10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Patients with a history of any secondary primary malignancy are ineligible with the following exceptions:

   * in situ carcinoma of the cervix or
   * adequately treated basal cell carcinoma of the skin or
   * ipsi- or contralateral non-invasive carcinoma of the breast (DCIS).
2. Patients in pregnancy or breastfeeding. If a patient gets pregnant during the participation in the interventional phase of the study (Year 1-5), an end of intervention visit will be scheduled and the patient will enter the follow-up phase of the study. Pregnancy during the follow-up phase of the study is to be reported but does not lead to an exclusion of the study.
3. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
4. Renal insufficiency with GFR \< 30 mL/min.
5. Previous or concomitant cytotoxic or other systemic antineoplastic treatment that is not used for treating the primary breast cancer.

Where it's running

• University Hospital Ulm Gynecology/Obstetrics
  Ulm, Germany Recruiting

Study contacts

• Principal investigator: Sophia Huesmann, Dr. — Universitätsklinikum Ulm
• Study coordinator: Sophia Huesmann, Dr.
• Email: sophia.huesmann@uniklinik-ulm.de
• Phone: +4973150058577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.