Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (CO
In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients
| Condition(s) | Early-stage Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy acts as surrogate marker for metastasis and overall survival. Therapy intensification by adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment (non-pCR). While this approach was exemplified in two phase III trials without biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by individualized genomic-guided post-neoadjuvant therapies. Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver molecularly-tailored cancer care by implementing an additional response- and genomics-guided post-neoadjuvant th |
| Who can participate | Inclusion Criteria: 1. Provision of written informed consent 2. Female and male patients with non-metastatic early (stage I-III) breast cancer aged ≥ 18 years 3. Conducted neoadjuvant chemotherapy and surgery as well as conducted standard post-neoadjuvant treatment +/- radiotherapy (standard according to German guidelines except Abemaciclib and Olaparib) 4. For patients with initially triple negative (TNBC) or HER2-positive breast cancer: • Non-pCR defined as other than ypT0/is ypN0 5. For patients with initially hormone receptor positive and HER2-negative breast cancer: Non-pCR and CPS-EG score * ≥ 3 and ypN0, or * ≥ 2 and ypN+ 6. ECOG Performance Status ≤ 1 7. Acute effects of any prior therapy resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adv |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | German Cancer Research Center |
| Locations | Heidelberg, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Augsburg, Bavaria, Germany; Erlangen, Bavaria, Germany; Ulm, Bavaria, Germany; Würzburg, Bavaria, Germany (+3 more sites) |
| Start date | 2023-06-29 |
| NCT ID | NCT05332561 |
| Official listing | https://clinicaltrials.gov/study/NCT05332561 |