Introduction Breast cancer is the most common cancer in women in the UK. For women who have early-stage oestrogen-receptor positive (ER+ve) disease, daily oral adjuvant endocrine therapy reduces risk of recurrence. Recently, CDK4/6 inhibitors, a form of biological therapy, have been approved for use alongside endocrine therapy. However, trial data suggest there may be challenges with adherence to CDK4/6 inhibitors. This study aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer. It will also co-develop an intervention to support women with adherence to these drugs alongside endocrine therapy through an evidence-based, theory-informed and patient-centred approach.Methods and analysis The SWEET-PLUS study has three phases. Phase I uses semi-structured interviews or focus groups to explore the experiences of women with early breast cancer who have been prescribed CDK4/6 inhibitors. It will also explore their support needs and experiences of adherence. Phase II involves interviews or focus groups with healthcare professionals who support CDK4/6 inhibitor prescription and associated care to understand the existing support and unmet needs. Phase I and II findings will inform phase III, which comprises workshops and user testing interviews to co-develop an intervention to support women with adherence to CDK4/6 inhibitors alongside endocrine therapy. This will be delivered as an additional module prototype designed for future integration into the existing HT&Me intervention, which supports women with adherence to endocrine therapy.Data from phases I and II will be analysed using a framework approach-based thematic analysis. Phase III data will be analysed through content analysis.Ethics and dissemination SWEET-PLUS received ethical approval from the National Health Services (NHS) Health Research Authority (Cambridge East Research Ethics Committee (25/EE/0220)). Research findings will be disseminated through peer-reviewed journal articles and via international and national conferences. Further dissemination will be guided by patient and public involvement.

Background Breast cancer and its treatment can have long-term adverse effects on physical and mental health. Evidence-based guidelines recommend that healthcare professionals (HCPs) advise women with breast cancer to engage in physical activity to improve health outcomes. However, support to be active is not standard care. The PURE-EX (EXpanding into communities to imProve physical activity sUpport foR womEn after breast cancer) programme aims to address this knowledge-practice gap. Aim To co-develop a programme that integrates physical activity referrals into standard care for women after treatment for early-stage and locally-advanced breast cancer. Programme components will include: 1. A referral pathway enabling HCPs to refer women to community-based physical activity programmes after they have completed primary treatment for breast cancer; 2. An online training course to support community providers in adapting their existing physical activity programmes for women who have undergone breast cancer treatment. Work Packages We will co-develop, refine, and evaluate PURE-EX programme components through four work packages (WPs): WP1. Conduct a systematic scoping review to describe the characteristics of community-based physical activity programmes for women with breast cancer reported in the literature. WP2. Undertake qualitative research with: (i) women with breast cancer, (ii) HCPs responsible for their care, and (ii) exercise professionals, to explore barriers and facilitators to incorporating physical activity into breast cancer care from different perspectives. WP3. Hold co-development events to develop and refine components of the PURE-EX programme and gain insights as to how it could be operationalised in practice. WP4. Conduct a feasibility trial in 45 women who have finished primary treatment for breast cancer to assess the feasibility and acceptability of the PURE-EX programme. Discussion The PURE-EX programme will be an evidence-based, theory-informed, and person-centred intervention, with the potential to make physical activity support routinely available for women after breast cancer treatment.

Background: Pathological complete response (pCR) rates are lower in ER positive, HER-2 positive early breast cancers (EBC) as compared to ER negative, HER2-positive disease when treated with neoadjuvant chemotherapy, trastuzumab and pertuzumab (T+P). To date, pivotal phase III neoadjuvant studies have not explored the impact of progesterone (PgR) status on pCR rates and outcomes. Given this, we explored the impact of PgR expression on pCR rates as well as clinical outcomes following neoadjuvant chemotherapy, and T+P in HER-2 positive EBC in patients treated at 4 cancer centres in the UK. Methods: Patients with HER2-positive EBC, treated with neoadjuvant chemotherapy, and T+P, between 2013-2024 at 4 cancer centres in the UK were identified. Clinicopathological information including ER and PgR status taken from core biopsy, with positivity defined as Quick Score >2, histopathological response, disease relapse and survival outcomes were collected. Data cut off was 1st March 2024. Results: 1037 patients were identified; 17 had bilateral disease making 1054 assessable tumours. Hormone receptor status was as follows: ER+, PgR+: 495 of 1054 (47%); ER+, PgR-: 158 of 1054 (15%); ER-, PgR+: 30 of 1054 (3%); ER-, PgR-: 297 of 1054 (28%); ER or PgR missing data: 74 of 1054 (7%). The overall pCR rate (ypT0/is, ypT0) was 52% (552/1054). pCR rates by ER status (regardless of PgR) were: ER+: 45% (293/653); ER-: 70% (229/327) (P < 0.0001). pCR rates by PgR status were: PgR+: 42% (221/524); PgR-: 66% (302/456) (P<0.0001). pCR rates by ER & PgR were: ER+, PgR+: 41% (204/495); ER+, PgR-: 56% (89/158); ER-/PgR+: 57% (17/30); ER-,PgR-: 71% (212/297). At a median follow-up of 34 months (95% CI 33-36) disease-free survival (DFS) and overall survival (OS), for the overall population was not reached. pCR was associated with improved DFS (HR 0.30, 95% CI 0.17-0.50) and OS (HR 0.29, 95% CI 0.13-0.62) in the overall patient group. In ER+ disease, regardless of PgR status, pCR was associated with improved DFS (HR 0.38, 95% CI 0.18-0.78) but not OS (HR 0.46, 95% CI 0.16-1.33). pCR in the ER- disease group, was associated with significantly improved DFS (HR 0.17 95% CI 0.07-0.38) and OS (HR 0.11, 95% CI 0.03-0.35). In PgR+ disease, achieving pCR lead to an improved DFS (DFS: HR 0.26, 95% CI 0.11-0.65) but not OS (HR 0.30, 0.08-1.09). In PgR- disease achieving pCR was associated with both improved DFS and OS (DFS: HR 0.29, 95% CI 0.15-0.59; OS: 0.22, 95% CI 0.08-0.58). In ER+/ PgR+ disease, an association was found for DFS (HR 0.26, 95% CI 0.09-0.69) but not for OS (HR 0.24, 95% CI 0.05-1.14). In ER+/ PgR- disease, pCR was not statistically significant for an improved DFS (HR 0.81, 95% CI 0.23-2.80) or OS (HR 1.22, 95% CI 0.20-7.34). pCR was significant for both DFS and OS in patients with ER-, PgR- disease (DFS: HR 0.18, 95% CI 0.07-0.42; OS: HR 0.10, 95% CI 0.02-0.36). An updated analysis with data from an additional 1 centre will be presented as well as updated outcomes. Discussion: In this multicentred, real-world study achieving pCR was associated with ER and PgR status, with higher rates in ER-/PgR- & ER+/PgR- cases versus ER+/PgR+ cases. DFS and OS in the overall population was associated with pCR, however this did not hold for all hormone receptor subgroups. Whilst an association was found for achieving pCR and DFS in the ER+/PgR+ patient group, only in ER-/PgR- disease was pCR significant for both DFS and OS. These data indicate that in ER+ HER2+ EBC PgR status can influence pCR, and survival outcomes. Citation Format: James Pearson, Henry Cain, Emily King, Mark Verill, Alicia Okines, Nicolò Matteo Luca Battisti, Sacha Howell, Rebecca Ward, Dinaksi Shah, Waleed Khalifa, Ian MacPherson, Andrew Kidd, Andrea Law, Vijay Sharma, Aswathy Nair, Richard Jackson, Carlo Palmieri. A multicentre UK Study of the impact of progesterone receptor status on pathological complete response rate and outcomes in 1037 patients with HER-2 positive, early breast cancer treated with neoadjuvant chemotherapy, trastuzumab and pertuzumab [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P3-11-23.

PURPOSE:Women with estrogen receptor-positive breast cancer are recommended daily oral adjuvant endocrine therapy for at least 5 years, but up to 50 % discontinue early. We assessed an evidence-based, theoretically-informed, patient-centred intervention (HT&Me) to support adjuvant endocrine therapy adherence and improve quality-of-life, in terms of patient acceptability and feasibility to deliver within the UK National Health Service. METHODS:This single arm study aimed to recruit 45 women with stage I-III breast cancer within 14 weeks of first adjuvant endocrine therapy prescription. After completing baseline questionnaires, participants received the HT&Me intervention comprising: (i) a short animation; (ii) two personalised nurse/practitioner consultations (in-person or online); (iii) an interactive web-app; and (iv) regular email reminders. Participants completed follow-up questionnaires at 8 weeks. A sub-sample of participants (n = 20) and health professionals (n = 14) participated in semi-structured interviews. RESULTS:We recruited 51 participants. Participants varied in digital confidence at recruitment (low/moderate, 28 % (n = 14); high, 61 % (n = 31)). HT&Me was demonstrated as feasible to deliver. Overall, 69 % (n = 35) engaged with the web-app; 87 % (n = 40/46) found HT&Me helpful; and 80 % (n = 36/45) reported it motivated them to keep taking endocrine therapy. Both consultation formats were considered acceptable. Completion of outcome measures was high. Health professionals considered HT&Me addresses an important unmet need. CONCLUSIONS:HT&Me is feasible, acceptable and helpful to women. Findings provided valuable insights for design and delivery of the full-scale randomised controlled trial assessing effectiveness now underway (ISRCTN24852890). HT&Me offers potential to improve adjuvant endocrine therapy adherence, thereby reducing recurrence risk for women with estrogen receptor positive breast cancer. STUDY REGISTRATION ISRCTN NUMBER:ISRCTN29401613.

Background:. In the United Kingdom, the rise in simple mastectomies without drain placement has contributed to improving rates of day-case surgery. However, this practice has resulted in increased rates of symptomatic seromas and greater resource burden in clinics. For postoperative incision management, we have implemented the use of closed incision negative pressure therapy (ciNPT) with foam dressings that cover the entire incision and surrounding tissues. The aim of this study was to establish whether the use of full-coverage ciNPT after mastectomy reduced seroma-related interventions. Methods:. Seroma intervention data were collected for patients undergoing mastectomies at a single center. Thirty sequential patients with conventional dressings placed between December 2020 and May 2021 and 25 sequential patients with ciNPT with full-coverage dressings between August 2021 and January 2022 were included in the study. Results:. There were 31 mastectomy cases in each arm (including bilateral cases). Twenty cases in the control group and 15 cases in the ciNPT group required a return to the clinic for seroma. In the control group, 16 incisions required at least 1 aspiration, versus 12 in the ciNPT group. Compared with the control group, the ciNPT group required fewer aspirations per mastectomy (P = 0.048) and had lower total aspiration volumes (P = 0.031). Conclusions:. In our clinic, nearly two-thirds of drainless mastectomy patients required postoperative visits for seromas. Patients managed with ciNPT dressings covering the entire breast required fewer seroma-related visits and experienced reduced total seroma volume.

Background Partial breast reconstruction (PBR) using chest wall perforator flaps (CWPFs) is an oncoplastic technique utilised to facilitate breast conservation surgery (BCS). It is particularly applicable in women with a larger tumour-to-breast volume ratio requiring volume replacement rather than volume displacement. This single-centre retrospective cohort study aimed to explore the safety and efficacy of PBR using CWPFs. Method All patients who underwent PBR using a CWPF following wide local excision between March 2016 and August 2024 were reviewed. Data was extracted from hospital electronic patient records and statistical analysis performed using R-Studio® (alpha = 0.05). Results Of 290 cases identified: 237 had invasive cancers and 53 ductal carcinoma in situ (DCIS). The median age at presentation was 59 years and the median tumour size 22 mm, with multifocal tumours in 22.1 % of cases and extensive DCIS in 27.0 % of invasive cancers. Overall, complication rates were low (n = 83, 28.6 %) with 6.9 % of patients requiring a return to theatre. Margins were involved in 17.8 %, with 15.6 % requiring re-excision. The locoregional recurrence (LRR) rate was 2.9 % and disease-free survival (DFS) 93.8 % with a median follow-up of 3.1 years (n = 276). A subset analysis of women receiving surgery before January 2020 (n = 96) with a follow-up of 5.1 years had a LRR of 4.2 %. Conclusion This study reports acceptable rates of complications, margin re-excision and LRR, demonstrating the safety and efficacy of utilising PBR with CWPFs for the treatment of breast cancer. CWPFs offer the opportunity to extend the boundaries of BCS to those women who may otherwise require a mastectomy.

BACKGROUND:Axillary node clearance is the current standard of care in patients with node-positive breast cancer undergoing primary surgery, despite a lack of evidence to demonstrate survival benefit and high rates of life-changing morbidity. Targeted axillary dissection (TAD) may be a safe alternative to axillary node clearance, but there is no agreement how primary TAD should be performed. TADPOLE-TOGETHER aimed to use international consensus methods to agree the key components of primary TAD to promote standardized introduction and evaluation of the technique within the TADPOLE trial. METHODS:A scoping review and key stakeholder interviews were used to generate a longlist of possible procedure steps for inclusion in the Delphi questionnaire. Two rounds of an international online survey were then used to agree the mandatory, optional, and prohibited steps of TAD, together with any standardization and training required. The final approach to primary TAD was agreed at an online consensus meeting. RESULTS:Thirteen potential steps of a TAD procedure were identified from the literature and expert interviews, together with information regarding standardization and training. Some 244 surgeons with global representation participated in the Round 1 survey, of whom 161 (66.0%) participated in Round 2. Seven mandatory steps of primary TAD, including localization and removal of the involved node, combined with a sentinel node biopsy, were agreed upon and ratified by 42 surgeons from the UK, Europe, and Asia who attended the consensus meeting. CONCLUSION:Robust international consensus methods have been used to agree how primary TAD should be performed, promoting safe and transparent introduction and evaluation of the technique.

At least 5 years of adjuvant endocrine therapy substantially reduces risks of recurrence and mortality in oestrogen-receptor positive early breast cancer. However, adherence to endocrine therapy is sub-optimal; poor adherence is associated with higher risks of recurrence and death from breast cancer, worse cancer-specific health-related quality-of-life, and increased healthcare costs. The SWEET randomised control trial aims to evaluate effectiveness and cost-effectiveness of the HT Me intervention in reducing poor adherence to adjuvant endocrine therapy and improve cancer-specific health-related quality-of-life in women with oestrogen-receptor positive early breast cancer. This is a UK based, pragmatic, open label randomised control trial. Participants (stages 1–3 oestrogen-receptor positive breast cancer, completed surgery, within 14 weeks of first endocrine therapy prescription; n = 1460) complete a baseline questionnaire, and are randomised to the HT Me intervention plus usual care, or usual care alone. The HT Me intervention is evidence-based, theory-informed and patient-centred. It consists of viewing an animation, two consultations with a SWEET study practitioner (a health care professional trained in delivering the intervention) approximately 3 months apart, access to the interactive HT Me web-app for the 18 months, and regular monthly nudges. All participants complete follow-up questionnaires at 6, 12, and 18 months. A multi-method process evaluation will be conducted involving quantitative analysis exploring mechanisms of action of the intervention, and qualitative interviews with a sample of participants and health care professionals involved in the trial. Primary endpoints are adjuvant endocrine therapy adherence (combined self-report (Medication Adherence Report Scale) and Proportion of Days Covered calculated from prescription encashment records) and cancer-specific health-related quality-of-life (Functional Assessment of Cancer Therapy Scale- General). Secondary endpoints are adjuvant endocrine therapy-specific health-related quality-of-life and within-trial cost-utility analysis which will evaluate cost-effectiveness. The SWEET trial seeks to address a significant issue affecting the growing population of breast cancer survivors: poor adherence to adjuvant endocrine therapy. Challenges addressed and resolved within the protocol include the following: capacity at sites to deliver the intervention; variations in breast cancer services nationally; and measuring adherence. This trial has potential to improve quality of life and adherence to endocrine therapy; reducing numbers of recurrences and breast cancer deaths, benefiting women, their families and the health service. ISRCTN Number: ISRCTN24852890 registered on 02.08.2023.

Background: As the focus of cancer survivorship shifts from solely improving oncological endpoints to a more holistic approach, greater weight is being placed on cosmetic and psychological outcomes. Reducing mastectomy rates improves patients' quality of life in numerous areas following breast cancer treatment. The advent and adoption of advanced oncoplastic techniques, particularly utilising therapeutic mammoplasty (TM) and chest wall perforator flap (CWPF) procedures, allows successful breast-conserving surgery (BCS) to patients who otherwise would have required a mastectomy. The aim of this study is to ascertain if the adoption of these procedures has assisted in the reduction of mastectomies performed.

Early-stage disease: likelihood (OR with 95% CI and P values from logistic regression) of receiving trastuzumab by deprivation and adjusted for age, ethnicity, rural/urban residence, government region, stage at diagnosis, whether received surgery, ER status, comorbidities, whether discussed at MDT meeting, and diagnosis year for women with stage I–III HER2+ breast cancer who were diagnosed between January 01, 2012 and December 31, 2017 (n = 34,616).