Clinical trial · Observational
Neo-RT: A Study Investigating Whether Changing the Sequence of Treatments (Starting Radiotherapy Followed by Hormone Therapy Before Surgery) is Feasible
Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.
- 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)
Four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. Breast conservation (removing the area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being. Intensity-modulated radiotherapy (IMRT) closely shapes the radiation beam to the cancer and is currently given after breast surgery. A new combination of IMRT followed by hormone treatment given before surgery, may increase the possibility of breast conservation.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast conserving surgery | Procedure | — | UNRESOLVED |
| Endocrine therapy | Drug | Hormone Therapy | ALIAS |
| Intensity modulated radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The proportion of patients successfully completing neo-adjuvant IMRT and endocrine treatment followed by beast surgery, as per study protocol.
- timeFrame
- 6 months
- description
- Successful completion of IMRT is defined as: * Treatment received was either 48 Gy/15# or 40 Gy/15# with sequential boost * Treatment received was 'other', but the reason for different schedule was not due to toxicity related from the radiotherapy * Radiotherapy treatment was not delayed by 5 days or more * Radiotherapy treatment was delayed by 5 days or more, but the reason was not due to toxicity related from the radiotherapy Successful completion of endocrine treatment is defined as: * Patient received at least 80% of endocrine treatment received * Patient did not receive 80% of endocrine treatment, but the reason was not due to toxicity or toxicity related from radiotherapy or endocrine Successful surgery is defined as: * Planned date of surgery is not delayed * Planned date of surgery is delayed, but the reason was not due to toxicity or toxicity related to radiotherapy or endocrine treatment.
Secondary outcomes (7)
- measure
- Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
- timeFrame
- 3 weeks
- description
- Acute radiotherapy toxicity following IMRT, assessed by CTCAE v4.03
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent to participate * Female * Aged 18 years and older * ECOG performance status 0-2 * Histology confirmed invasive breast cancer * ER positive (Allred score 6-8) * HER2 negative * Palpable size ≥20mm * Grade I-II (or grade III if considered not suitable for neo-adjuvant chemotherapy) * Considered that radiotherapy will make breast conserving surgery easier * No evidence of non-breast malignancy if treated with curative intent unless the patient has been disease free ≥5 years * Unifocal or multifocal disease, i.e. tumour in the same quadrant and breast conserving surgery still feasible Exclusion Criteria: * Contraindications to breast radiotherapy or neo-adjuvant endocrine therapy * Bilateral breast cancer * Metastatic cancer * Multicentric disease * Concomitant medical/psychiatric problems preventing completion of study treatment or follow-up * Pregnancy * Breast feeding
References
Publications (0)
Data not yet available