MRI and Early Decision-making in Chemotherapy for Breast Cancer

NCT02449824 | Completed

• 1 other identifier: MO15/085
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond. Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.

Conditions

Breast Neoplasms

Keywords

neoadjuvant chemotherapy; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change in tumour blood flow between baseline and after 1 cycle of neoadjuvant chemotherapy

  Cycle 1 length \~ 2 weeks.

  2 weeks

Secondary Outcomes (3)

• Rate of change in tumour blood flow measured at baseline, after 1 cycle, 3 cycles and 6 cycles of NAC & pathological response.

  ~18 weeks

• Tumour blood flow at baseline, after 1 cycle and after 6 cycles compared with molecular markers measured from biopsy data obtained at baseline and after 1 cycle and measured from surgical specimens taken after 6 cycles.

  ~15 weeks

• Within patient coefficient of variation in the measure of blood flow obtained at 2 baseline visits.

  2 weeks

Study Arms (1)

magnetic resonance imaging

Participants will undergo MRI at baseline, after 1 cycle, 3 cycles and at completion of neoadjuvant chemotherapy.

Other: magnetic resonance imaging

Interventions

magnetic resonance imaging OTHER

early MRI

Also known as: MRI

magnetic resonance imaging

Eligibility Criteria

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

Study Population

Female patients aged over 18 years with invasive carcinoma of the breast who, following discussion at the breast multidisciplinary team (MDT) meeting, are to be treated in Leeds using NAC with curative intent will be approached to take part in this study (this includes HER2+ patients receiving trastuzumab); the sample will thus reflect the general population of patients receiving NAC.

You may qualify if:

• Clinical indication for NAC as determined by the Breast Therapeutic MDT.
• Sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
• Participant is willing and able to give informed consent for participation in the study.
• Female, aged 18 years or above.
• Histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
• Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
• Participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min).
• In the Investigator's opinion, is able and willing to comply with all study requirements.

You may not qualify if:

• Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
• Significant renal impairment (estimated glomerular filtration rate \< 30 ml/min).
• Contraindication to MRI.

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust, St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumour biopsy samples and blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• David L Buckley, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Physics

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 20, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2018
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)