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The HeartSpare Study

Optimisation and individualisation of heart-sparing breast radiotherapy techniques: a randomised controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53585935
Enrollment
73
Registered
2012-02-06
Start date
2012-02-01
Completion date
Unknown
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

Study design: These are single-centre non-blinded randomised cross-over trials (RCT) comparing i) treatment in voluntary deep inspiartor breath-hold (v_DIBH) versus Active Breathing Co

Sponsors

The Royal Marsden Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy 2. Recommendation for whole breast (Group A and B) or chest wall radiotherapy (Group A only) (with or without tumour bed boost) 3. Age =18 4. Performance status =1 5. Patients able to tolerate breath-ho 6. Target Gender: Female 7. Lower Age Limit is 18 years

Exclusion criteria

Exclusion criteria: 1. Requirement for nodal irradiaion 2. Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance 3. Previous radiotherapy to any region above the diaphragm

Design outcomes

Secondary

MeasureTime frame
Group B: Difference in mean LAD NTDmean - difference in mean normal tissue dose (NTDmean) (Gy) to left anterior-descending coronary artery

Primary

MeasureTime frame
Group A: Reproducibility - interfraction reproducibility of patient position (mean daily displacements of chest wall) in v_DI

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026