NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer

NCT04118192 | Active Not Recruiting

• 1 other identifier: RG_16-108
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 24

Brief Summary

A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies

Conditions

Breast Cancer

Keywords

breast cancer; HER2 positive; ER negative; Tumour bed core biopsies

Outcome Measures

Primary Outcomes (1)

• Observed number of patients with false negative biopsies

  The observed number of patients with false negative biopsies (i.e. no tumour in the biopsy but tumour in the surgical specimen) as a proportion of all those assessed by Local Histopathology Review.

  12 months post last patient recruited

Secondary Outcomes (7)

• Concordance between Local and Central Histopathology Review of core biopsies

  12 months post last patient recruited

• Compliance with treatment

  12 months post last patient recruited

• Time to local recurrence

  Number of days from registration to local recurrence (if within trial duration, approximately 1.5 years)

• Time to distant recurrence

  Number of days from registration to distant recurrence (if within trial duration, approximately 1.5 years)

• Overall survival

  Whole days from registration to death from any cause (if within trial duration, approximately 1.5 years)

Interventions

Tumour bed core biopsy PROCEDURE

Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HER-2 positive ER-negative breast cancer patients

You may qualify if:

• Patient with histological diagnosis of operable HER2-positive, ER-negative, early stage invasive breast cancer
• Tumour size ≥ 1cm and visible on US (T1c to T4d)
• Patient fit and willing to receive, or is already receiving and has received no more than five cycles of a NOSTRA-Feasibility Study approved treatment regimen, in the opinion of the responsible clinician
• Eastern Co-operative Group (ECOG) performance status of 0 or 1
• Women of child-bearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
• Female, 18 years or older
• Able to provide informed consent for the study
• Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
• The radiology team are able and willing to perform the tumour bed core biopsies

You may not qualify if:

• Previous ipsilateral invasive breast cancer or Ductal Carcinoma in Situ (DCIS)
• Unequivocal evidence of distant metastatic disease at registration
• Multi-focal disease at diagnosis
• Active malignancy
• Previous chemotherapy
• Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
• Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
• Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
• Prior diagnosis of cardiac failure
• Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
• Bleeding diathesis
• Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
• Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)
• Patient lactating
• Patients who have received live vaccine within 4 weeks of the date of study entry

Sponsors & Collaborators

• University of Birmingham: lead
• Roche Pharma AG: collaborator
• Cancer Research UK: collaborator

Study Sites (24)

Basildon Hospital

Basildon, Essex, SS16 5NL, United Kingdom

Location

Belfast City Hospital

Belfast, United Kingdom

Location

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Blackpool Teaching Hospitals NHS Trust

Blackpool, FY3 8NR, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

University Hospital of Llandough

Cardiff, CF64 2XX, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, GL53 7AN, United Kingdom

Location

Dumfries and Galloway Royal Infirmary

Dumfries, United Kingdom

Location

Western General

Edinburgh, United Kingdom

Location

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Liverpool Hospital

Liverpool, L7 8XP, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Borders General Hospital

Melrose, TD6 9BS, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Poole Hospital

Poole, BH15 2JB, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Singleton Hospital

Swansea, United Kingdom

Location

Arrowe Park Hospital

Upton, CH49 5PE, United Kingdom

Location

Thomas Linacre Centre

Wigan, WN1 1RU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour bed core biopsies

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel Rea

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: October 8, 2019
• Study Start: May 22, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

GB (24)