Breast CancerNOSTRANCT04118192
NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer
An observational study of Breast Cancer, run by University of Birmingham at 24 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tumour bed core biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- 22 May 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HER-2 positive ER-negative breast cancer patients
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites
Basildon Hospital
Basildon, Essex, SS16 5NL
Belfast City Hospital
Belfast
City Hospital
Birmingham, B18 7QH
Queen Elizabeth Hospital
Birmingham
Blackpool Teaching Hospitals NHS Trust
Blackpool, FY3 8NR
Southmead Hospital
Bristol, BS10 5NB
University Hospital of Llandough
Cardiff, CF64 2XX
Cheltenham General Hospital
Cheltenham, GL53 7AN
Dumfries and Galloway Royal Infirmary
Dumfries
Western General
Edinburgh
Northwick Park Hospital
Harrow, HA1 3UJ
St James's University Hospital
Leeds, LS9 7TF
Royal Liverpool Hospital
Liverpool, L7 8XP
Royal Marsden Hospital
London, SW3 6JJ
Borders General Hospital
Melrose, TD6 9BS
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Nottingham City Hospital
Nottingham, NG5 1PB
Peterborough City Hospital
Peterborough, PE3 9GZ
Poole Hospital
Poole, BH15 2JB
Weston Park Hospital
Sheffield, S10 2SJ
Southampton General Hospital
Southampton, SO16 6YD
Singleton Hospital
Swansea
Arrowe Park Hospital
Upton, CH49 5PE
Thomas Linacre Centre
Wigan, WN1 1RU
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Tumour bed core biopsy
- Keywords
- breast cancer, HER2 positive, ER negative, Tumour bed core biopsies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour bed core biopsyProcedure or surgery
Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post last patient recruited
Secondary outcomes (7)
Concordance between Local and Central Histopathology Review of core biopsies
The number of patients whose initial local pathological assessment of pCR is confirmed by Central Histopathology Review.
Measured: 12 months post last patient recruited
Compliance with treatment
Assessed by calculating relative dose intensity taking into account both reductions in dose and delays to treatment.
Measured: 12 months post last patient recruited
Time to local recurrence
Defined in whole days from date of registration to local recurrence or death from any cause. Patients who are alive and without local recurrence at the time of analysis will be censored at the date last seen.
Measured: Number of days from registration to local recurrence (if within trial duration, approximately 1.5 years)
Time to distant recurrence
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 known to be alive.
Measured: Number of days from registration to distant recurrence (if within trial duration, approximately 1.5 years)
Overall survival
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.
Measured: Whole days from registration to death from any cause (if within trial duration, approximately 1.5 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
This will be reported as a proportion of all recruited patients.
Measured: Post-last patient last surgery (within approximately 1.5 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
Sensitivity, specificity and false negative rates will be reported.
Measured: Post-last patient last surgery (within approximately 1.5 years of start of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start22 May 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Daniel Rea, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118192
- Sponsor's protocol ID
- RG_16-108
- Acronym
- NOSTRA
- Status last verified
- Jan 2025
- First submitted
- 5 Sep 2019
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?
- ClinicalTrials.gov ID
- NCT04118192
- Acronym / sponsor ID
- NOSTRA / RG_16-108
- Conditions
- Breast Cancer
- Keywords
- breast cancer, HER2 positive, ER negative, Tumour bed core biopsies
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Cancer Research UK
- Study start
- 22 May 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HER-2 positive ER-negative breast cancer patients
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour bed core biopsyCollection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment | Procedure or surgery | – |
Primary outcome
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.
7 secondary outcomes
Concordance between Local and Central Histopathology Review of core biopsies
Time frame: 12 months post last patient recruited
Compliance with treatment
Time frame: 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 1.5 years)
Time to distant recurrence
Time frame: Number of days from registration to distant recurrence (if within trial duration, approximately 1.5 years)
Overall survival
Time frame: Whole days from registration to death from any cause (if within trial duration, approximately 1.5 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 1.5 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 1.5 years of start of trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rea principal investigator
University of Birmingham
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Birmingham at 24 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed number of patients with false negative biopsies (time frame: 12 months post last patient recruited). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.