A study to help understand the outcomes of pre-surgical treatment for breast cancer

Neoadjuvant systemic therapy in breast cancer: a national prospective multicentre audit of neoadjuvant systemic therapy in breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11160072

Enrollment

1000

Registered

2019-06-10

Start date

2017-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

Interventions

Participants in this study have been diagnosed with breast cancer and will be receiving standard treatment with medical therapy (either chemotherapy, endocrine therapy or targeted therapy). Data will

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age > 16 years 2. Histologically confirmed diagnosis of breast cancer 3. MDT recommended treatment of neoadjuvant systemic therapy (either hormonal or chemotherapy) - including patients entering into clinical trials of neoadjuvant systemic therapy.

Exclusion criteria

Exclusion criteria: 1. Patients entering “window of opportunity” clinical trials

Design outcomes

Primary

Measure	Time frame
1. Investigate variation in practice in the use of neoadjuvant systemic therapy in the UK Measurement – percentage of patients being treated with neoadjuvant chemotherapy and endocrine therapy and tumour molecular subtypes. Timepoint – baseline (at diagnosis). 2. Assess surgical practice following neoadjuvant therapy Measurement – percentage of patients having mastectomy/breast conserving surgery. Timepoint – after completion of neoadjuvant therapy 3. Determine pathological response rates after neoadjuvant therapy in current UK practice Measurement – pathological complete response rate reported in all patients. Timepoint – after completion of neoadjuvant therapy.	—

Measure

Time frame

1. Investigate variation in practice in the use of neoadjuvant systemic therapy in the UK Measurement – percentage of patients being treated with neoadjuvant chemotherapy and endocrine therapy and tumour molecular subtypes. Timepoint – baseline (at diagnosis). 2. Assess surgical practice following neoadjuvant therapy Measurement – percentage of patients having mastectomy/breast conserving surgery. Timepoint – after completion of neoadjuvant therapy 3. Determine pathological response rates after neoadjuvant therapy in current UK practice Measurement – pathological complete response rate reported in all patients. Timepoint – after completion of neoadjuvant therapy.

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Secondary

Measure	Time frame
1. Explore the stated indications for the use of neoadjuvant systemic therapy in the UK Measurement – indications given by multidisciplinary team for choice of treatment. Timepoint – baseline 2. Examine treatment regimens in common use Measurement – prescribed treatment regimens for neoadjuvant therapy. Timepoint – at commencement of standard therapy. 3. Investigate how response to neoadjuvant therapy for breast cancer is assessed and reported across the UK. Measurement – number of patients having imaging during therapy. Timepoints – mid-treatment and at completion of treatment 4. Investigate surgical management of the axilla following neoadjuvant therapy Measurement – percentage of patients have sentinel node biopsy and axillary node clearance before and after neoadjuvant therapy. Timepoints – at start of treatment and after completion of neoadjuvant treatment.	—

Measure

Time frame

1. Explore the stated indications for the use of neoadjuvant systemic therapy in the UK Measurement – indications given by multidisciplinary team for choice of treatment. Timepoint – baseline 2. Examine treatment regimens in common use Measurement – prescribed treatment regimens for neoadjuvant therapy. Timepoint – at commencement of standard therapy. 3. Investigate how response to neoadjuvant therapy for breast cancer is assessed and reported across the UK. Measurement – number of patients having imaging during therapy. Timepoints – mid-treatment and at completion of treatment 4. Investigate surgical management of the axilla following neoadjuvant therapy Measurement – percentage of patients have sentinel node biopsy and axillary node clearance before and after neoadjuvant therapy. Timepoints – at start of treatment and after completion of neoadjuvant treatment.

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Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactStuart McIntosh

s.mcintosh@qub.ac.uk02890972986

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026