Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer

Not Applicable

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN12852634
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28779963 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30532984 (added 20/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-28
• Last Update Posted: 21 January 2020
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2018

Inclusion Criteria

Current inclusion criteria as of 26/02/2019:
1. Age greater than or equal to 50 years
2. Primary breast conservation surgery +/- adjuvant systemic therapy
3. Pathological tumour size ? 3.0 cm pT1-2 (< 3.1 cm, maximum microscopic diameter of invasive component)
4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
5. Unifocal disease
6. Grade I, II or III
7. Lymphovascular invasion present or absent
8. Axillary lymph nodes negative or 1 to 3 nodes positive (pN0 or pN+(1-3))
9. Minimum microscopic margin of non-cancerous tissue ? 2 mm (excluding deep margin if this is at deep fascia)
10. No blood-borne metastases

Previous inclusion criteria:
1. Age greater than or equal to 50 years
2. Primary breast conservation surgery +/- adjuvant systemic therapy
3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component)
4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
5. Unifocal disease (Grade I or II)
6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia)
7. No lympho-vascular invasion
8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed)
9. No blood borne metastases

Exclusion Criteria

Current exclusion criteria as of 26/02/2019:
1. Previous malignancy (other than non-melanomatous skin cancer)
2. Mastectomy
3. Invasive carcinoma of classical lobular type
4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is <3.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
5. Concurrent chemo-radiotherapy

Previous exclusion criteria:
1. Previous malignancy (other than non-melanomatous skin cancer)
2. Mastectomy
3. Invasive carcinoma of classical lobular type
4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
5. Concurrent chemo-radiotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified