Associations between the ultrasound features of invasive breast cancer and breast cancer specific survival.

AIM: To assess whether ultrasound features of breast cancer are associated with breast cancer specific survival (BCSS). MATERIALS AND METHODS: Within a single breast service, data was collected prospectively (April 2010-April 2012) from 319 consecutive women (mean age 63 years) with 335 ultrasound-visible invasive breast cancers. Ultrasound features were evaluated retrospectively from the recorded images according to the Breast Imaging Reporting and Data System (BI-RADS) lexicon by a radiologist blinded to outcomes. Survival and cause of death were ascertained from local and national sources. Kaplan-Meier survival curves were generated, and statistical significance tested using the log-rank test. RESULTS: Mean follow-up in those alive was 80.9 months. Thirty breast cancer deaths and 45 non-breast cancer deaths occurred. Five-year BCSS in the presence of distal acoustic enhancement was 76% compared to 88%, 96%, and 100% for those with distal shadowing, no distal effect or combined effect respectively (p<0.0002). Patients with sonographic skin involvement had 73% 5-year BCSS compared to 92% for no skin involvement (p<0.0001). Focal oedema was associated with 56% 5-year BCSS compared to 89% for those without (p=0.0002). A significant association was demonstrated between ultrasound tumour size and BCSS (p<0.0001). At multivariate analysis, skin changes, distal enhancement, and focal oedema maintained prognostic significance. CONCLUSION: Distal enhancement, focal oedema, and skin involvement have strong associations with breast cancer death. These factors could be taken into account, along with lesion size and other commonly used preoperative prognostic features, when considering management of women with breast cancer.

Audit of eliminating biopsy for presumed fibroadenomas with benign ultrasound greyscale and shear-wave elastography findings in women aged 25-39 years.

AIM: To assess the safety of a policy of not biopsying presumed fibroadenomas with benign ultrasound and shear-wave elastography findings in women aged 25-39 years. MATERIALS AND METHODS: Patients aged 25-39 years were included after attending a one-stop clinic before 01/05/2019 where clinical and ultrasound greyscale findings suggested a benign mass and shear-wave elastography showed a mean stiffness of <50 kPa. Such patients were reassured and discharged without biopsy or follow-up. The archived ultrasound images were reviewed subsequently by a second radiologist who could recall patients for biopsy if he deemed the imaging findings to be not definitively benign. Local and national electronic records were reviewed to identify whether these patients later re-presented with breast problems. RESULTS: Seventy-six women with a mean age of 33 years were included. The minimum follow-up was 12 months and the mean follow-up was 2 years. Three (4%) of patients were recalled after review of the ultrasound images by a second radiologist. Five (7%) patients re-presented with the same lump. Three (4%) patients re-presented with a different benign problem. Two patients presented with breast cancer in the ipsilateral breast but at a different location from the assessed benign lesion. CONCLUSION: Early audit results of a policy of not biopsying or following up clinically benign masses with benign ultrasound greyscale appearances and shear wave stiffness <50 kPa in women aged 25-39 years suggest that this approach may be safe and acceptable.

Percutaneous sentinel node removal using a vacuum-assisted needle biopsy in women with breast cancer: a feasibility and acceptability study.

AIMS: To assess the feasibility and acceptability of large-gauge percutaneous removal of the axillary sentinel lymph node (SLN) using dual gamma probe and ultrasound guidance. MATERIALS AND METHODS: Technetium nanocolloid was administered the day before surgery. On the day of surgery, potential SLNs were identified with gamma probe and ultrasound scanning. A 7 G vacuum-assisted biopsy (VAB) device was inserted percutaneously deep to the target node and the node(s) removed. The gamma probe was used to confirm removal of radiolabelled tissue. At surgery, any residual radiolabelled or blue nodes were removed. Morbidity was assessed via (1) a pain questionnaire immediately after the percutaneous procedure, (2) relevant items from the FACT B+4 questionnaire 7-10 days after surgery, and (3) case note review 1 month after surgery. RESULTS: Twenty-two patients consented and 20 patients underwent the procedure. Radiolabelled nodal tissue was obtained in 18/20 (90%). The mean procedure time was 11 minutes. Four of 18 patients had metastatic disease identified in the VAB excision tissue with 100% sensitivity for axillary metastasis. At axillary surgery, additional intact SLN or fragments were found in 14 patients. No additional metastatic disease was found at surgery. One patient suffered a pneumothorax during instillation of local anaesthetic. The median pain score was 10/100 by visual analogue scale. Immediate post-procedure haematoma was common (14 of 20) and prolonged manual compression frequent. CONCLUSION: VAB removal of sentinel nodes using dual scanning is feasible. Although preliminary sensitivity and specificity levels are encouraging, complications may discourage widespread implementation.

Identification of pathological complete response after neoadjuvant chemotherapy for breast cancer: comparison of greyscale ultrasound, shear wave elastography, and MRI.

AIM: To assess the value of post-treatment shear-wave elastography (SWE) parameters (maximum stiffness [Emax], mean stiffness [Emean], and standard deviation [SD]) compared to greyscale ultrasonography (US) and magnetic resonance imaging (MRI) in identifying pathological complete response (pCR) to neoadjuvant chemotherapy (NACT) in breast cancer. MATERIALS AND METHODS: In a prospective cohort study, 80 patients receiving NACT for breast cancer underwent baseline and post-treatment US, SWE, and MRI examinations. Four SWE images in two orthogonal planes were obtained. Maximum greyscale US diameter and maximum diameter of lesion enhancement on MRI were measured. Percentage reductions between baseline and post-treatment scans were calculated for MRI and greyscale US diameter, and Emean, Emax, and SD. The percentage reduction in Emean and US diameter were also analysed as a combination. Analysis was undertaken using receiver operating characteristic (ROC) curves and the chi-squared test. RESULTS: pCR occurred in 21 of 80 (26%) women. The area under the ROC curve (AUC) for pCR of percentage reductions in Emean, Emax, SD, and greyscale US diameter were 0.89, 0.85, 0.75, and 0.86, respectively. The combination of percentage reductions in Emean and greyscale ultrasound diameter yielded an AUC of 0.92, which is similar to the AUC for MRI of 0.96 (p=0.28). CONCLUSIONS: SWE combined with greyscale US shows promise for end-of-treatment identification of response to NACT in women with breast cancer, with accuracies similar to breast MRI. This technique could be used to inform surgical decision-making after NACT.

Clinical performance of Siemens digital breast tomosynthesis versus standard supplementary mammography for the assessment of screen-detected soft-tissue abnormalities: a multi-reader study.

AIM: To compare the diagnostic accuracy of standard screening images plus single-view digital breast tomosynthesis (DBT), using Siemens DBT equipment, with standard screening images plus supplementary mammographic views in non-calcific, screen-detected mammographic abnormalities. MATERIALS AND METHODS: Participants were unselected women aged 50-69 years recalled within a population-based European breast screening programme for assessment of soft-tissue mammographic abnormalities. Supplementary mammographic views (SMVs) and DBT were performed in all cases. A range of equipment was used for screening and supplementary mammography, but all DBT examinations were performed using the Siemens Mammomat Inspiration. A retrospective multi-reader study including 238 cases for whom either histology or at least 2 years' follow-up was available was performed with eight suitably accredited UK breast screening personnel reading all cases under both conditions, with temporal separation. Readers were blinded to case outcomes and findings from other examinations. Diagnostic accuracy using receiver operating characteristic (ROC) analysis was compared between screening plus SMV images and screening plus DBT images. The study was powered to detect a 3% inferiority margin in diagnostic accuracy between methods. RESULTS: The final sample with complete data available for analysis included 195 benign cases (1,560 reads) and 35 malignant cases (280 reads). The DBT method yielded a slightly higher area under the curve (AUC) value than the SMV method (0.870 versus 0.857), but the difference was not statistically significant (p=0.4890), indicating that the methods have equivalent accuracy. CONCLUSION: Siemens DBT demonstrates equivalent diagnostic accuracy according to ROC curve analysis when used in place of SMVs in screen-detected soft-tissue mammographic abnormalities.

Client and practitioner perspectives on the screening mammography experience.

Mammography can be painful and unpleasant, but effective interventions to improve the experience remain scarce. As a first step towards more effective interventions, we aimed to achieve a thorough, contemporary understanding of thoughts, feelings and behaviours which affect and arise from mammography experiences. Research and professional experience suggest that the interaction between client and practitioner may be paramount in determining the quality of a client's experience. Therefore, this study aimed to capture the perspectives of clients and mammography staff from UK breast screening programmes. Thematic analysis of semi-structured qualitative in-depth interviews with 22 clients and 18 staff revealed that clients had positive attitudes to breast screening and mostly low knowledge about potential harms. Staff data indicated that some women attend for breast screening under pressure from others. Pain and coping with it were prominent themes, with wide variations in pain experiences. Clients recognised differences in mammographers' abilities to put them at ease. Staff difficulties included empowering clients within the confines of a taxing technique, and maintaining compassionate care when under strain. Future intervention development should focus on the information and support needs of women prior to the appointment and on effectively training and supporting mammographers to deal with challenging encounters.

Factors influencing the stiffness of fibroadenomas at shear wave elastography.

AIM: To identify which features of fibroadenomas are associated with false-positive findings at shear wave elastography (SWE). MATERIALS AND METHODS: A total of 151 patients with histologically confirmed fibroadenomata were identified from a prospective database, from a single breast unit. The following features were assessed by two observers who were unaware of the SWE findings: patient age, grey-scale ultrasound lesion diameter (<15 or ≥15 mm), distance from the lesion to skin, composition of surrounding tissue (fatty, mixed or dense), and source of referral (screening or symptomatic). Statistical analysis was carried out using the chi-square test. RESULTS: A statistically significant positive association was found between grey-scale ultrasound lesion size and lesion stiffness. Twenty-nine of 70 (41%) lesions ≥15 mm were stiff, versus 10 of 81 (12%) <15 mm (p=0.001). Patient age, distance from the lesion to skin, make-up of surrounding tissue, and source were not significantly associated with stiffness. CONCLUSION: Fibroadenomas giving false-positive SWE results tend to be larger in size than those that do not. More compression of adjacent normal tissue is assumed to be the cause of the present findings. As previous studies have shown that large cancers tend to be stiffer than smaller cancers, it may be appropriate to vary the quantitative cut-off value used for benign/malignant differentiation in SWE according to lesion size.

Value of shear-wave elastography in the diagnosis of symptomatic invasive lobular breast cancer.

AIM: To investigate the contribution of shear-wave elastography (SWE) in diagnosing invasive lobular breast cancer (ILC) in symptomatic patients. MATERIALS AND METHODS: A retrospective case-controlled study of 52 patients with ILC and 52 patients with invasive ductal cancer (IDC), matched for age and tumour size, was performed. Breast density and mammographic and greyscale ultrasound features were graded using Breast Imaging-Reporting and Data System (BI-RADS) classification by two radiologists, blinded to SWE and pathology findings. Forty-four benign lesions were also included. The sensitivity of SWE was assessed, using a cut-off value of 50 kPa for mean elasticity. Statistical significance was evaluated using Chi-square and Chi-square for trend tests. RESULTS: Mean age for both ILC and IDC groups was 67 years. Mean size for ILC was 44 mm and IDC was 37 mm. The sensitivity for detection of ILC and IDC for mammography, greyscale ultrasound, and SWE were 79% versus 87%, 87% versus 98%, 94% versus 100%, respectively. SWE had significantly higher sensitivities than mammography for the detection of both ILC and IDC (p = 0.012 and p = 0.001, respectively). SWE was not significantly more sensitive than greyscale ultrasound for the detection of either tumour type. Four (8%) lobular cancers were benign/normal at both mammography and greyscale ultrasound, but suspicious on SWE. The incremental gain in sensitivity by using SWE in ILC was statistically significant compared to IDC (p = 0.01). CONCLUSION: SWE can diagnose lobular cancers that have benign/normal findings on conventional imaging as suspicious.

Accuracy of non-operative identification of the sentinel lymph node using combined gamma and ultrasound scanning.

AIM: To assess how accurately the sentinel lymph node (SLN) can be identified percutaneously, using gamma probe and ultrasound technology. MATERIALS AND METHODS: Women with breast cancer, scheduled for wide local excision or mastectomy with SLN biopsy (SLNB), were included. Peri-areolar intradermal injection of technetium-99 nanocolloid was performed on the morning of surgery and 1-2 ml of blue dye was injected in the peri-areolar region once the patient was anaesthetized. Prior to surgery, a gamma probe was used over the skin to identify any hot spot that could represent a SLN. Ultrasound, guided by the hot spot, was then used to visualize potential SLNs and guide the insertion of a localizing wire. The accuracy in localizing the SLN by preoperative gamma-probe guided ultrasonography was assessed by comparison to SLNB. RESULTS: A SLN was correctly identified and marked using gamma-probe guided ultrasonography in 44 of 59 cases (75%; 95% CI: 63-86%). CONCLUSION: This study supports the case for investigating percutaneous gamma probe and ultrasound guided interventions in the axilla in women with breast cancer, as a potential alternative to surgical SLNB.

What are the characteristics of breast cancers misclassified as benign by quantitative ultrasound shear wave elastography?

OBJECTIVES: Shear wave elastography (SWE) is a promising adjunct to greyscale ultrasound in differentiating benign from malignant breast masses. The purpose of this study was to characterise breast cancers which are not stiff on quantitative SWE, to elucidate potential sources of error in clinical application of SWE to evaluation of breast masses. METHODS: Three hundred and two consecutive patients examined by SWE who underwent immediate surgery for breast cancer were included. Characteristics of 280 lesions with suspicious SWE values (mean stiffness >50 kPa) were compared with 22 lesions with benign SWE values (<50 kPa). Statistical significance of the differences was assessed using non-parametric goodness-of-fit tests. RESULTS: Pure ductal carcinoma in situ (DCIS) masses were more often soft on SWE than masses representing invasive breast cancer. Invasive cancers that were soft were more frequently: histological grade 1, tubular subtype, ≤10 mm invasive size and detected at screening mammography. No significant differences were found with respect to the presence of invasive lobular cancer, vascular invasion, hormone and HER-2 receptor status. Lymph node positivity was less common in soft cancers. CONCLUSION: Malignant breast masses classified as benign by quantitative SWE tend to have better prognostic features than those correctly classified as malignant. KEY POINTS: • Over 90 % of cancers assessable with ultrasound have a mean stiffness >50 kPa. • 'Soft' invasive cancers are frequently small (≤10 mm), low grade and screen-detected. • Pure DCIS masses are more often soft than invasive cancers (>40 %). • Large symptomatic masses are better evaluated with SWE than small clinically occult lesions. • When assessing small lesions, 'softness' should not raise the threshold for biopsy.

Comparison of mammographic findings after intraoperative radiotherapy or external beam whole breast radiotherapy.

BACKGROUND: The TARGIT (TARGeted Intraoperative Radiotherapy) trial was designed to compare local recurrence and complication rates in breast cancer patients, prospectively randomised to either EBRT (external beam whole breast radiotherapy) or a single dose of IORT (intraoperative radiotherapy). The aim of our study was to compare follow-up mammographic findings, ultrasound and biopsy rates in each group. METHODS: Follow-up imaging and breast biopsies of women from one centre participating in the TARGIT-A trial were independently reviewed by two radiologists blinded to the radiotherapy treatment received. RESULTS: The cohort consisted of 141 patients (EBRT n = 80/IORT n = 61). There was no significant difference in the patient or disease characteristics of the two groups. The number of follow-up mammograms and length of follow-up was similar (EBRT/IORT n = 2.0/2.4; 4.3yr/5.1yr; p = 0.386 χ(2) test). There were no significant differences in mammographic scar or calcification appearances of the post-operative site. Generalised increase in breast density and skin thickening were more common in the EBRT compared to the IORT group (p = 0.002; p = 0.030, χ(2) test respectively). A trend towards additional ultrasound at follow-up was observed in the IORT group (15 of 61 [24.6%] versus 11 of 80 [13.8%]), however this was not statistically significant (p = 0.100 χ(2) test). No disease recurrence was demonstrated on any of the breast biopsies taken. Only one biopsy was reported as fat necrosis in the IORT group. CONCLUSIONS: Mammographic changes were more common following EBRT, although more additional follow-up ultrasounds were performed in the IORT group. IORT is not detrimental to subsequent radiological follow up.

Can shear-wave elastography predict response to neoadjuvant chemotherapy in women with invasive breast cancer?

BACKGROUND: Response of invasive breast cancer to neoadjuvant chemotherapy (NAC) is variable, and prediction of response is imperfect. We aimed to ascertain whether tissue stiffness in breast cancers, as assessed by shear-wave elastography (SWE) before treatment, is associated with response. METHODS: We retrospectively compared pre-treatment tumour mean tissue stiffness, with post-treatment Residual Cancer Burden (RCB) scores and its components in 40 women with breast cancer treated by NAC using Pearson's correlation coefficient (CC), a general linear model and multiple linear regression. Subgroup analysis was carried out for luminal, HER2-positive and basal immuno-histochemical subtypes. RESULTS: Statistically significant correlations were shown between stiffness and RCB scores and between stiffness and percentage tumour cellularity. The correlation between stiffness and percentage cellularity was strongest (CC 0.35 (P<0.0001) compared with CC 0.23 (P=0.004) for the RCB score). The results of a general linear model show that cellularity and RCB score maintain independent relationships with stiffness. By multiple linear regression, only cellularity maintained a significant relationship with stiffness. CONCLUSION: Pre-treatment tumour stiffness measured by SWE, has a statistically significant relationship with pathological response of invasive breast cancer to NAC.

Can additional histopathological examination of ultrasound-guided axillary lymph node core biopsies improve preoperative diagnosis of primary breast cancer nodal metastasis?

AIM: To assess whether an additional histopathological examination of ultrasound-guided core biopsy (USCB)/fine-needle aspiration (FNA) of abnormal axillary lymph nodes (ALN) can improve the preoperative diagnosis of axillary nodal metastasis. MATERIALS AND METHODS: Women with suspected invasive breast cancer and abnormal axillary ultrasound (AUS), but negative USCB on standard histopathological assessment were included. From the core biopsies six additional levels were sectioned for haematoxylin and eosin examination, and two levels were sectioned for immunohistochemistry with AE1/3. The presence of metastatic disease was noted. RESULTS: The USCB of 102 patients were submitted for additional histopathological examination, of whom 58 had screen-detected lesions and 44 had symptomatic lesions. Eighty underwent axillary surgery for invasive carcinoma (n = 74) or for ductal carcinoma in situ (DCIS) requiring mastectomy (n = 6). Twelve patients were found to have nodal disease with a mean of two nodes involved. The additional histopathological assessment of the nodal USCBs revealed tumour not seen at the standard examination in only three cases, which consisted of isolated tumour cells (n = 2) and micrometastasis (n = 1). All three patients underwent subsequent axillary node clearance; however, no upgrade of axillary disease was found at final histopathology. CONCLUSION: Additional histopathological examination of USCBs of radiologically abnormal ALN does not improve the preoperative diagnosis of axillary nodal metastasis in primary breast cancer and may lead to unnecessary axillary clearance.

Differentiating benign from malignant solid breast masses: value of shear wave elastography according to lesion stiffness combined with greyscale ultrasound according to BI-RADS classification.

BACKGROUND: The aim of this study was to assess the performance of shear wave elastography combined with BI-RADS classification of greyscale ultrasound images for benign/malignant differentiation in a large group of patients. METHODS: One hundred and seventy-five consecutive patients with solid breast masses on routine ultrasonography undergoing percutaneous biopsy had the greyscale findings classified according to the American College of Radiology BI-RADS. The mean elasticity values from four shear wave images were obtained. RESULTS: For mean elasticity vs greyscale BI-RADS, the performance results against histology were sensitivity: 95% vs 95%, specificity: 77% vs 69%, Positive Predictive Value (PPV): 88% vs 84%, Negative Predictive Value (NPV): 90% vs 91%, and accuracy: 89% vs 86% (all P>0.05). The results for the combination (positive result from either modality counted as malignant) were sensitivity 100%, specificity 61%, PPV 82%, NPV 100%, and accuracy 86%. The combination of BI-RADS greyscale and shear wave elastography yielded superior sensitivity to BI-RADS alone (P=0.03) or shear wave alone (P=0.03). The NPV was superior in combination compared with either alone (BI-RADS P=0.01 and shear wave P=0.02). CONCLUSION: Together, BI-RADS assessment of greyscale ultrasound images and shear wave ultrasound elastography are extremely sensitive for detection of malignancy.

A comparison of the accuracy of film-screen mammography, full-field digital mammography, and digital breast tomosynthesis.

AIM: To measure the change in diagnostic accuracy of conventional film-screen mammography and full-field digital mammography (FFDM) with the addition of digital breast tomosynthesis (DBT) in women recalled for assessment following routine screening. MATERIALS AND METHODS: Ethics approval for the study was granted. Women recalled for assessment following routine screening with screen-film mammography were invited to participate. Participants underwent bilateral, two-view FFDM and two-view DBT. Readers scored each lesion separately for probability of malignancy on screen-film mammography, FFDM, and then DBT. The scores were compared with the presence or absence of malignancy based on the final histopathology outcome. RESULTS: Seven hundred and thirty-eight women participated (93.2% recruitment rate). Following assessment 204 (26.8%) were diagnosed as malignant (147 invasive and 57 in-situ tumours), 286 (37.68%) as benign, and 269 (35.4%) as normal. The diagnostic accuracy was evaluated by using receiving operating characteristic (ROC) and measurement of area under the curve (AUC). The AUC values demonstrated a significant (p = 0.0001) improvement in the diagnostic accuracy with the addition of DBT combined with FFDM and film-screen mammography (AUC = 0.9671) when compared to FFDM plus film-screen mammography (AUC = 0.8949) and film-screen mammography alone (AUC = 0.7882). The effect was significantly greater for soft-tissue lesions [AUC was 0.9905 with the addition of DBT and AUC was 0.9201 for FFDM with film-screen mammography combined (p = 0.0001)] compared to microcalcification [with the addition of DBT (AUC = 0.7920) and for FFDM with film-screen mammography combined (AUC = 0.7843; p = 0.3182)]. CONCLUSION: The addition of DBT increases the accuracy of mammography compared to FFDM and film-screen mammography combined and film-screen mammography alone in the assessment of screen-detected soft-tissue mammographic abnormalities.

Axillary lymph node core biopsy for breast cancer metastases -- how many needle passes are enough?

AIM: To determine the diagnostic yield of each of three core passes when sampling abnormal lymph nodes in patients presenting with breast cancer. MATERIALS AND METHODS: All patients suspected of having breast cancer had axillary ultrasound as part of initial assessment. Radiologically abnormal nodes (cortical thickness >2.3mm or round shape) were biopsied with three passes of a 22 mm throw 14 G core biopsy needle and sent for histopathology in separate numbered pots. Data were collected prospectively, and analysis performed on the data of 55 consecutive patients who had positive nodes on at least one core biopsy needle pass. RESULTS: Of 55 patients with a positive node on core biopsy, tumour was noted in all three cores taken in 39 (70.9%). Lymph node metastasis was detected in 45 (81.8%) first core biopsies. With the first two cores taken, positive results were detected in 53 of 55 cases (96.4%). In both cases where tumour was only found on a third core biopsy pass, no lymph node tissue was present in the first two biopsy passes. CONCLUSION: Two well-directed 14 G core biopsy samples from an abnormal axillary node are adequate for diagnosis of breast cancer metastasis.

Breast screening policy: are we heading in the right direction?

There is a large body of evidence supporting 2-yearly screening of women aged 50-69 years. There is good evidence for a mortality reduction from mammographic screening in women aged 40 to 49 years but a 1-year interval is required. The lack of specificity of screening in young women does remain a problem. There is no evidence to suggest that a single screen between the ages of 47 and 50 years within a programme screening at 3-year intervals will reduce mortality; the trials showing a mortality benefit in women in their 40s included multiple screening episodes and shorter screening intervals. There is no randomized, controlled trial evidence to support screening in women aged above 70 years and screening this age group will cause greater harm than in younger women through higher rates of over-diagnosis and consequent over-treatment. The randomized phase of the screening age extension, which at the moment is planned to last only 6 years, should not be immediately followed by general implementation of the policy. Only if and when additional mortality reductions and an acceptable balance between benefit and harms are shown to be achieved by the extra screens should the 2007 Cancer Reform Strategy policy on age extension be implemented. Resources saved by delaying or abandoning the roll-out of the age extension could potentially be redirected towards reducing the current 3 year screening interval to 2 years in women aged 50-69 years. However, reducing the screening interval to 2 years for women aged 50-69 years would require significantly more screening invitations and resources than the proposed age extension.

Promoting early presentation of breast cancer: development of a psycho-educational intervention.

OBJECTIVES: Women who delay presenting with breast cancer have a reduced chance of survival. Older women, who are at greater risk of developing breast cancer, are more likely to delay presenting with the disease. The aim of this developmental work was to design a psycho-educational intervention to promote early help-seeking by older women with breast cancer symptoms. We also aimed to demonstrate the feasibility of implementing the intervention with women attending for their final invited mammogram in the National Health Service (NHS) Breast Screening Programme. METHODS: The intervention was designed to address the factors associated with delayed presentation by women with breast cancer. These risk factors were placed in a theoretical framework to understand patient delay. The intervention incorporated behavioural change techniques that, according to previous research, have been demonstrated to be effective. RESULTS: The intervention was developed in two formats to be delivered by diagnostic radiographers: a booklet alone and a brief interview plus the booklet. The intervention was acceptable to both older women and healthcare professionals in the NHS Breast Screening Programme. DISCUSSION: The intervention will be tested ultimately in a multicentre randomized controlled trial to determine whether it can reduce the proportion of older women who delay their presentation and thereby save lives.