Clinical trial · Interventional
The HeartSpare Plus 1B Trial
The HeartSpare Plus 1B Trial: A Randomised Phase II Trial Comparing the Resource Impact, Acute Toxicity and Feasibility of Different Pan-lymph Node Radiotherapy Techniques for Breast Cancer Patients
- 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 aims to compare the resource impact, acute toxicity and feasibility of different pan-lymph node radiotherapy techniques. Radiotherapy using wide tangents with the patient in breath hold will be compared against volumetric modulated arc therapy (VMAT) in free breathing in the main trial. A parallel study will asses the accuracy of VMAT treatments using voluntary deep inspiratory breath hold compared to an active breathing controlled breath hold device.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VMAT_FB | Radiation | — | UNRESOLVED |
| WT_vDIBH | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WT_vDIBH
- description
- Wide tangent radiotherapy in voluntary deep inspiratory breath hold
- interventionNames
- Radiation: WT_vDIBH
- type
- ACTIVE_COMPARATOR
- label
- VMAT_FB
- description
- Volumetric modulated arc therapy in free breathing.
- interventionNames
- Radiation: VMAT_FB
Primary outcomes (1)
- measure
- Linear Accelerator time
- timeFrame
- 3 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Female or male * Invasive carcinoma of the breast (left or right-sided) * Breast conservation surgery or mastectomy * Axillary staging and/or dissection * pT1-T4,N1-2,M0 disease * Histological involvement of axillary lymph nodes * Indication for radiotherapy to the IMC, axillary levels I-III and/or level IV * Patient able to tolerate breath hold * Performance status 0-1 Exclusion Criteria: * Contralateral and/or previous ipsilateral breast cancer, irrespective of date of diagnosis * Past medical history of malignancy except (i) basal cell skin carcinoma, (ii) CIN cervix uteri, (iii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free * Previous radiotherapy to any region above the diaphragm
References
Publications (0)
Data not yet available