Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Observation: Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone. Status of Menopause Disease status Anti-tumor therapy Survival Treatment after end of the study The patient will be treated during and after end of study by physician's choice.

Study summary

Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

Eligibility

Primary outcome measure(s)

• Distant metastasis free survival — 10 years
  To show that female patients who have been tested as "low risk" by EndoPredict® (EPclin) and have been treated with endocrine therapy only for at least 5 years have a 10-year distant metastasis-free survival (DMFS) \> 90 % (lower boundary of the one-sided 95 % confidence interval)

Trial sites (40)

More North Eastern German Society of Gynaecological Oncology trials in Germany