The HeartSpare Study

Phase 2

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN53585935
• Lead Sponsor: The Royal Marsden Foundation Trust (UK)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23726115 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25739317

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-06
• Study Completion: 2013-11-30
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 73

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Group A: Reproducibility - interfraction reproducibility of patient position (mean daily displacements of chest wall) in v_DI

Secondary Outcome Measures

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