A study to determine the feasibility of undertaking a large scale study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction

Conditions

Breast reconstruction after breast cancer diagnosis Cancer Malignant neoplasm of breast

Shelley Potter, Charlotte Davies, Leigh Johnson, Carmel Conefrey, Nikki Mills et al. (13 authors)

Clinical Cancer Research2025-06-13

Clinical and patient-reported outcomes in women offered oncoplastic breast-conserving surgery as an alternative to mastectomy: ANTHEM multicentre prospective cohort study

Charlotte Davies, Leigh Johnson, Carmel Conefrey, Nicola Mills, Patricia Fairbrother et al. (13 authors)

British journal of surgery2024-12-247 citations

10.1093/bjs/znae306

Understanding decision-making for and against oncoplastic breast-conserving surgery as an alternative to a mastectomy in early breast cancer: UK ANTHEM qualitative study

Charlotte Davies, Carmel Conefrey, Nicola Mills, Patricia Fairbrother, Chris Holcombe et al. (12 authors)

British journal of surgery2024-06-017 citations

10.1093/bjs/znae133

Abstract PO2-22-11: 'A sledgehammer to crack a nut' or 'the safer option'? Understanding decision making for and against oncoplastic breast conserving surgery as an alternative to mastectomy in women with early breast cancer: The UK ANTHEM study

Charlotte Davies, Carmel Conefrey, Nicola Mills, Patricia Fairbrother, Chris Holcombe et al. (12 authors)

Cancer Research2024-05-02

10.1158/1538-7445.sabcs23-po2-22-11

Abstract PO3-23-06: Short-term clinical and patient-reported outcomes of oncoplastic breast conserving surgery and mastectomy with and without immediate breast reconstruction: The UK ANTHEM multicentre prospective cohort study

Charlotte Davies, Leigh Johnson, Carmel Conefrey, Nikki Mills, Patricia Fairbrother et al. (13 authors)

Cancer Research2024-05-02

10.1158/1538-7445.sabcs23-po3-23-06

Protocol for a mixed-method study to inform the feasibility of undertaking a large-scale multicentre study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction in women unsuitable for standard breast-conserving surgery (the ANTHEM Feasibility Study)

Charlotte Davies, Christopher Holcombe, Joanna Skillman, Lisa Whisker, William Hollingworth et al. (12 authors)

BMJ Open2021-04-019 citations

10.1136/bmjopen-2020-046622

Interventions

Eligible patients will be identified from the breast cancer and if applicable oncoplastic multidisciplinary team (MDT) meetings as being potentially eligible for either OPBCS or mastectomy. Patient’s

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female patients over 18 years of age 2. Invasive breast cancer or ductal carcinoma in situ (DCIS) not considered suitable for standard BCS or simple level 1 techniques 3. Assessed by the breast cancer (and oncoplastic, if applicable) multidisciplinary team (MDT) and the operating surgeon as being suitable candidates for either OPBCS (either TM or LPF) as an alternative to a mastectomy OR mastectomy with or without an immediate breast reconstruction (using any technique) and offered both OPBCS and mastectomy options 4. No restrictions will be placed on the size of the tumour as decisions on the suitability of a patient for simple BCS will be based on assessments of the size of the tumour relative to the overall size of the breast and its position within the breast rather than on explicit size criteria

Exclusion criteria

Exclusion criteria: 1. Women offered OPBCS for reasons other than to avoid mastectomy (e.g. quality of life if large breasted) 2. Women offered standard BCS or level 1 procedures only 3. Women not able or willing to give informed consent

Design outcomes

Primary

Measure	Time frame
Outcomes relate to the feasibility of identifying and recruiting patients offered different approaches to Oncoplastic Breast Conservation Surgery (OPBCS) to avoid mastectomy and to explore the utility of the BREAST Q as an outcome measure for the main study. 1. Centres and surgeons: 1.1. The provision of OPBCS in breast and plastic surgical units across the UK and the numbers of surgeons currently offering patients OPBCS (volume displacement (therapeutic mammaplasty [TM]) and replacement (local perforator flaps, [LPF] techniques) as an alternative to mastectomy measured using data from the ANTHEM national practice questionnaire (NPQ), collected at the beginning of the study. 1.2. The approximate numbers of OPBCS (TM and LPF) procedures offered to patients who would otherwise require a mastectomy at local centres across the UK (to inform the feasibility of a future large-scale study) measured using data from the ANTHEM screening and enrolment logs at the screening and recruitment stage of the study. 1.3. The variations in the indications and contraindications for different approaches to OPBCS (TM and LPF) and immediate breast reconstruction (implant-based; pedicled and free-flaps) across the UK in particular what patient (e.g. age, body mass index, smoking), tumour (e.g. size; multifocality) and treatment (neoadjuvant therapy; need for post-mastectomy radiotherapy) factors influence decision making (to estimate the potential magnitude of benefit of OPBCS in the mastectomy population i.e. portion of patients eligible for OPBCS who would not be suitable for immediate breast reconstruction), measured using data collected from study case report forms at baseline, 3 months and 12 months post-surgery. 1.4. The coding of OPBCS procedures to inform the feasibility of undertaking data linkage in the future study, measured from process mapping and data collected from study care report forms at the beginning of the study. 2. Participants and pathways: 1.1. The proporti	—

Measure

Time frame

Outcomes relate to the feasibility of identifying and recruiting patients offered different approaches to Oncoplastic Breast Conservation Surgery (OPBCS) to avoid mastectomy and to explore the utility of the BREAST Q as an outcome measure for the main study. 1. Centres and surgeons: 1.1. The provision of OPBCS in breast and plastic surgical units across the UK and the numbers of surgeons currently offering patients OPBCS (volume displacement (therapeutic mammaplasty [TM]) and replacement (local perforator flaps, [LPF] techniques) as an alternative to mastectomy measured using data from the ANTHEM national practice questionnaire (NPQ), collected at the beginning of the study. 1.2. The approximate numbers of OPBCS (TM and LPF) procedures offered to patients who would otherwise require a mastectomy at local centres across the UK (to inform the feasibility of a future large-scale study) measured using data from the ANTHEM screening and enrolment logs at the screening and recruitment stage of the study. 1.3. The variations in the indications and contraindications for different approaches to OPBCS (TM and LPF) and immediate breast reconstruction (implant-based; pedicled and free-flaps) across the UK in particular what patient (e.g. age, body mass index, smoking), tumour (e.g. size; multifocality) and treatment (neoadjuvant therapy; need for post-mastectomy radiotherapy) factors influence decision making (to estimate the potential magnitude of benefit of OPBCS in the mastectomy population i.e. portion of patients eligible for OPBCS who would not be suitable for immediate breast reconstruction), measured using data collected from study case report forms at baseline, 3 months and 12 months post-surgery. 1.4. The coding of OPBCS procedures to inform the feasibility of undertaking data linkage in the future study, measured from process mapping and data collected from study care report forms at the beginning of the study. 2. Participants and pathways: 1.1. The proporti

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Secondary

Measure	Time frame
Clinical and patient-reported outcomes measures (PROMs) measured at baseline, 3 months and 12 months post-surgery: 1. Satisfaction with breasts measured using BREAST Q 2. Psychosocial well-being measured using BREAST Q 3. Chest physical well-being measured using BREAST Q 4. Sexual well-being measured using BREAST Q 5. Quality of life measured using EQ-5D-5L 6. Normality measured using ICECAP-A	—

Countries

England, United Kingdom

Contacts

Public ContactCharlotte Davies

Charlotte.Davies@bristol.ac.uk+44 (0)117 9287209

Outcome results

None listed