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

May 9, 2023 updated by: University of Birmingham

Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Belfast, United Kingdom
        • Recruiting
        • Belfast City Hospital
        • Contact:
          • Eimear Nicholl
        • Principal Investigator:
          • Stuart McIntosh
      • Birmingham, United Kingdom
        • Recruiting
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Daniel Rea
        • Contact:
          • Shilpa Pius
      • Blackpool, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Teaching Hospitals NHS Trust
        • Contact:
          • Pavel Bezecny
        • Principal Investigator:
          • Pavel Bezecny
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • Southmead Hospital
        • Contact:
          • Sam Loud
        • Principal Investigator:
          • Alexandra Valencia
      • Cardiff, United Kingdom, CF64 2XX
        • Recruiting
        • University Hospital of Llandough
        • Contact:
          • Goyal Sumit
        • Principal Investigator:
          • Goyal Sumit
      • Cheltenham, United Kingdom, GL53 7AN
        • Recruiting
        • Cheltenham General Hospital
        • Contact:
          • Daniel Nelmes
        • Principal Investigator:
          • Daniel Nelmes
      • Dumfries, United Kingdom
        • Recruiting
        • Dumfries and Galloway Royal Infirmary
        • Contact:
          • Janice Duignan
        • Principal Investigator:
          • Aisling Hennessy
      • Edinburgh, United Kingdom
        • Recruiting
        • Western General
        • Contact:
          • Richard Allan
        • Principal Investigator:
          • Caroline Michie
      • Harrow, United Kingdom, HA1 3UJ
        • Recruiting
        • Northwick Park Hospital
        • Contact:
          • Prasanna Gurung
        • Principal Investigator:
          • Sabina Rashid
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Contact:
          • Amy Barber
        • Principal Investigator:
          • Sebastian Trainor
      • Liverpool, United Kingdom, L7 8XP
        • Recruiting
        • Royal Liverpool Hospital
        • Contact:
          • Alison McNamee
        • Principal Investigator:
          • Julia Henderson
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
          • Holly Hogan
        • Principal Investigator:
          • Marios Tasoulis
      • Melrose, United Kingdom, TD6 9BS
        • Recruiting
        • Borders General Hospital
        • Contact:
          • Carol Bedi
        • Principal Investigator:
          • Carol Bedi
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Royal Victoria Infirmary
        • Principal Investigator:
          • Henry Cain
        • Contact:
          • Henry Cain
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham City Hospital
        • Contact:
          • Steve Chan
        • Principal Investigator:
          • Steve Chan
      • Peterborough, United Kingdom, PE3 9GZ
        • Recruiting
        • Peterborough City Hospital
        • Contact:
          • Sarah Ayers
        • Principal Investigator:
          • Sarah Ayers
      • Poole, United Kingdom, BH15 2JB
        • Recruiting
        • Poole Hospital
        • Contact:
          • Abigail Evans
        • Principal Investigator:
          • Abigail Evans
      • Sheffield, United Kingdom, S10 2SJ
        • Recruiting
        • Weston Park Hospital
        • Principal Investigator:
          • Matthew Winter
        • Contact:
          • Matthew Winter
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
        • Contact:
          • Ramsey Cutress
        • Principal Investigator:
          • Ramsey Cutress
      • Swansea, United Kingdom
        • Recruiting
        • Singleton Hospital
        • Contact:
          • Nia Viney
        • Principal Investigator:
          • Marianne Dillon
        • Contact:
          • Helen Cheley
      • Upton, United Kingdom, CH49 5PE
        • Recruiting
        • Arrowe Park Hospital
        • Principal Investigator:
          • Raman Vinayagam
        • Contact:
          • Raman Vinayagam
      • Wigan, United Kingdom, WN1 1RU
        • Recruiting
        • Thomas Linacre Centre
        • Contact:
          • Jenny Cannon
        • Principal Investigator:
          • Konstantinos Zacharioudakis
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon Hospital
        • Contact:
          • Zina Aladili
        • Principal Investigator:
          • Zina Aladili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HER-2 positive ER-negative breast cancer patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
  • Patient unfit and/or unwilling to undergo surgery
  • Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
  • Patient has started protocol non-compliant neo-adjuvant chemotherapy
  • Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs
  • Patient has already received more than five cycles of approved neoadjuvant chemotherapy

Additional Inclusion Criteria for ctDNA Sub-Study

  • Patient has not yet started neoadjuvant treatment
  • Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observed number of patients with false negative biopsies
Time Frame: 12 months post last patient recruited
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between Local and Central Histopathology Review of core biopsies
Time Frame: 12 months post last patient recruited
is defined as the number of patients whose initial local pathological assessment of pCR is confirmed by Central Histopathology Review
12 months post last patient recruited
Compliance with treatment
Time Frame: 12 months post last patient recruited
assessed by calculating relative dose intensity taking into account of both reductions in dose and delays to treatment.
12 months post last patient recruited
Time to local recurrence
Time Frame: Number of days from registration to local recurrence (if within trial duration, approximately 6.5 years)
Compliance with neoadjuvant and adjuvant treatment; will be assessed by calculating relative dose intensity taking into account of both reductions in dose and delays to treatment.
Number of days from registration to local recurrence (if within trial duration, approximately 6.5 years)
Time to distant recurrence
Time Frame: Number of days from registration to local recurrence (if within trial duration, approximately 6.5 years)
defined in whole days from date of registration to distant recurrence or death from any cause. Patients who are alive and without distant recurrence at the time of analysis will be censored at the date last seen.
Number of days from registration to local recurrence (if within trial duration, approximately 6.5 years)
Overall survival
Time Frame: Whole days from registration to death from any cause (if within trial duration, approximately 6.5 years)
defined in whole days as the date of registration to death from any cause. Patients alive at the time of analysis will be censored at the date last seen.
Whole days from registration to death from any cause (if within trial duration, approximately 6.5 years)
Re-evaluation of the primary outcome using the central pathological review determination of RCB to define false negative biopsies as RCB-0 or 1 (i.e. no tumour or minimal residual disease) in the core biopsies but RCB-2 or 3 in the surgical specimen
Time Frame: Post-last patient last surgery (within approximately 6.5 years of start of trial)
This will be reported as a proportion of all recruited patients
Post-last patient last surgery (within approximately 6.5 years of start of trial)
Ability of the axillary lymph node assessments post-neoadjuvant treatment to identify definitive axillary lymph node involvement determined by surgery histopathology
Time Frame: Post-last patient last surgery (within approximately 6.5 years of start of trial)
Sensitivity, specificity and false negative rates will be reported.
Post-last patient last surgery (within approximately 6.5 years of start of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Roche Pharma AG
Cancer Research UK

Investigators

  • Principal Investigator: Daniel Rea, University of Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2019

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_16-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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