Clinical trial · Interventional
Neoadjuvant Chemotherapy Followed by Radiotherapy Alone in Patients With Breast Cancer
NCT03213925CI-TRIAL-00028563unknownPhase 2ClinicalTrials.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)
After neoadjuvant chemotherapy, patients normally receive either conservative breast surgery or mastectomy followed by radiation therapy. Some patients achieve a complete response after neoadjuvant chemotherapy. Considering that radiation therapy is an effective treatment for subclinical microscopic disease, the question arises whether breast surgery before radiation therapy can be avoided in the subgroup of patients with complete response after neoadjuvant chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RT
- description
- After clinical response, breast magnetic resonance imaging (MRI) is performed and analyzed by two independent radiologists. Complete image response is defined by no enhanced tumor visible on any serial images. Radiation therapy to the breast with or without regional nodal area is performed within 12 weeks after completion of chemotherapy with conventional dose (25x200cGy). Additional boost of 16 Gy in the primary involved tumor region.
- interventionNames
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Ipsilateral breast tumor recurrence (IBTR)
- timeFrame
- 5 years
- description
- IBTR is defined from the date from complete response of neoadjuvant chemotherapy to the date of any ipsilateral locoregional recurrence or deth.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 40 years or older * Pathologically confirmed unicentric invasive breast cancer * Clinical stage T1-3 / N0 or N2 / M0 * Clinical conditions to receive neoadjuvant chemotherapy Exclusion Criteria: * Prior diagnosis of cancer (exception: in situ cervical tumor and non-melanoma skin) * Patient is known to be pregnant * Prior history of radiation therapy in the thoracic region * Impossibility to perform magnetic resonance imaging
References
Publications (0)
Data not yet available
No reference posted for this study.