Clinical trial · Interventional
Neoadjuvant Chemotherapy in Breast Cancer
Optimizing Neoadjuvant Systemic Treatment for Breast Cancer by Clinical Decision Support System
NCT04802941CI-TRIAL-00050742unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study compares two approaches of upfront chemotherapy in breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decision Support Systems, Clinical | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General practice | Drug | — | UNRESOLVED |
| Neoadjuvant Chemotherapy by CDSS (MedicBK) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Chemotherapy by CDSS
- interventionNames
- Device: Neoadjuvant Chemotherapy by CDSS (MedicBK)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant Chemotherapy in General practice
- interventionNames
- Drug: General practice
Primary outcomes (1)
- measure
- Number of patients with pathological complete response
- timeFrame
- at week 30
- description
- To compare the efficacy of Neoadjuvant Chemotherapy in general practice and by CDSS
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Age ≥18 * Eastern Cooperative Oncology Group performance status ≤1 * Adequate bone marrow function (ANC \>1.5 x 109/l, platelets \>100 x 109/l) * Adequate hepatic function (ALAT, ASAT and bilirubin \<2.5 times upper limit of normal) * Adequate renal function (creatinine clearance \>50 ml/min) * LVEF ≥50% measured by echocardiography or MUGA * Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Absence of any medical condition that would place the patient at unusual risk. * Signed written informed consent Exclusion Criteria: * previous radiation therapy or chemotherapy * other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy. * current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection * evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures. * evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast. * concurrent anti-cancer treatment or another investigational drug.
References
Publications (0)
Data not yet available
No reference posted for this study.