NCT02701348

Brief Summary

The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started May 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2020

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

4.7 years

First QC Date

December 15, 2015

Last Update Submit

August 5, 2021

Conditions

Breast Cancer

Keywords

neoadjuvant endocrine

Outcome Measures

Primary Outcomes (3)

  • Change in Proliferative response

    Pathological response to treatment by proliferation (Ki67) (%)

    At surgery, min 3 months max 24 months

  • Change in Pathological response

    Residual cancer burden score

    At surgery, min 3 months max 24 months

  • Change in Shearwave stiffness

    shearwave stiffness (kPa)

    0,3,6, up to 24 months

Secondary Outcomes (6)

  • Change in peritumoural imaging on MRI

    0 months and surgery (min 3 months, max 24 months)

  • caveolin-1

    0 months and at time of surgery (min 3 months, max 24 months)

  • Monocarboxyl transport 4

    0 months and at time of surgery (min 3 months, max 24 months)

  • lysyl oxidase

    0 months and at time of surgery (min 3 months, max 24 months)

  • fibronectin

    0 months and at time of surgery (min 3 months, max 24 months)

  • +1 more secondary outcomes

Interventions

Shearwave elastographyOTHER

Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, ultrasound (US) including shearwave elastography (SWE). These will be performed at 3 monthly intervals until surgical intervention is considered feasible.

LetrozoleDRUG

Patients will be receiving neoadjuvant letrozole as standard therapy for breast cancer

Also known as: Aromatase inhibitor
Breast core biopsyPROCEDURE

Core biopsies will be taken at diagnosis, and at the time of surgery to allow biological assessment of changes in tumour

Magnetic Resonance ImagingOTHER

Breast MRI scans will be performed at time of diagnosis and prior to surgery to allow comparison of MRI change and response to treatment

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women: Defined as \>12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses \<12 months before starting treatment, FSH \>35 IU/L and LH \>40 IU/L.
  • ER positive (Allred score \>3) invasive breast cancer
  • Staging as T1-4, N0-2, M0
  • Patient agreed to neoadjuvant endocrine therapy as recommended by MDT
  • Fresh tissue stored at time of diagnostic core biopsy
  • Suitable for, and tolerant of MRI scan
  • Fit for surgical intervention at time of entry into study

You may not qualify if:

  • Premenopausal or unable to determine menopausal status
  • Not fit for surgical intervention due to co-morbidities
  • Contraindication for MRI (including severe claustrophobia)
  • Current use of HRT, or HRT use at time of diagnostic core biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stefani Clinical Trials Unit, Ninewells Hospital and Medical School

Dundee, Angus, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LetrozoleAromatase InhibitorsMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • E. Jane Macaskill, MBChB, MD, FRCSEd

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jane MacAskill

Study Record Dates

First Submitted

December 15, 2015

First Posted

March 8, 2016

Study Start

May 1, 2016

Primary Completion

December 24, 2020

Study Completion

December 24, 2020

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

No individual data sharing

Locations

GB(1)