Safe surgery for multiple breast cancers

Not Applicable

Completed

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

• Registration Number: ISRCTN17987569
• Lead Sponsor: niversity College London

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35227311/ Qualitative results (added 28/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Study Completion: 2020-10-31
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Aged >40 years with MIBC
2. Minimum of two invasive foci of breast cancer
3. Suitable for Therapeutic Mammoplasty
4. Fit for adjuvant therapy
5. Willing and able to provide written informed consent

Exclusion Criteria

1. Neo-adjuvant therapy ?
2. Women considered high risk by local centre or known to have BRCA1/2 gene mutation ?
3. Ductal Carcinoma in situ (DCIS) only, and extensive DCIS ?
4. Bilateral breast cancers ?
5. Previous breast cancer (invasive or DCIS in either breast) ?
6. Pregnancy as confirmed on blood tests or ultrasound examination.
7. Metastatic disease.
8. Any previous type of breast radiotherapy ?
9. Significant other clinical risk factors and co-morbidities at the discretion of the treating clinicians.
10. Previous or concomitant malignancy except adequately treated: non-melanomatous skin cancer; in situ carcinoma of the cervix and in situ melanoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of a larger trial, assessed using:<br>1. Numbers of women with more than one cancer in the same breast (MIBC) screened for the trial by 36 months<br>2. Numbers of eligible women based on trial criteria and suitable for therapeutic mammoplasty by 36 months<br>3. The proportion of women eligible for the trial who provide written informed consent by 36 months<br>4. Rate of compliance with allocated treatment and reason for deviation by 36 months

Secondary Outcome Measures

Name	Time	Method
1. Reasons why patients accept or decline randomisation, assessed from patient-completed Qualitative Study questionnaire<br>2. Views of clinical staff assessed using qualitative interviews<br>3. Views of participating patients assessed using qualitative interviews