An observational study to see if a breast Magnetic Resonance Imaging (MRI) of women recently diagnosed with breast cancer impacts on their treatment planning and cancer outcomes (BCT 2001)

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Cancer - Breast; Public Health - Other public health

• Registration Number: ACTRN12620000282987
• Lead Sponsor: Breast Cancer Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-03
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 406

Inclusion Criteria

For inclusion in the study, participants must fulfil all the following criteria:
1) Provide written, informed consent to participate in the study.
2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and:
a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR
b. < 70 years with invasive lobular cancer; AND/OR
c. < 50 years; AND/OR
d. With reported extreme breast density on mammogram (as defined by the local site); AND/OR
e. Breast diagnostic team suggests MRI may contribute to management.
3) Must have had pre-MRI treatment plan determined by diagnostic/treatment team including:
a. Type of planned breast and axillary surgery;
b. Type of planned radiotherapy to breast/node/chest wall;
c. Type of planned systemic therapy (including chemotherapy, HER2 directed therapy, endocrine therapy, neoadjuvant therapy).
4) Be willing and able to comply with requirements of study.
5) Completed baseline PROMs after signing consent and willing to complete specified PROMs in English throughout out the study.

Exclusion Criteria

Any one of the following is regarded as a criterion for exclusion from the study:
1) Distant metastatic disease beyond the breast and locoregional ipsilateral lymph nodes.
2) Locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement.
3) Previous cancer on the same side.
4) Classical lobular carcinoma in situ (LCIS) (pleomorphic LCIS is acceptable).
5) Other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent curative intent surgery to the breast primary and lymph nodes.
6) Undergone study specific MRI before registration. Study specific MRI can only occur after registration.
7) Unable to undergo MRI:
a. MRI is not suitable for participants with any of the following: pacemaker, implanted non-MRI compatible devices, cochlear implants, neurostimulators, insulin infusion pumps, estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2.
b. Compatibility checks are required for: aneurysm clips, those with a history of metallic ocular foreign bodies, vascular coils, stents and filters, eye implants and heart valve replacements.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients whose suggested treatment changes from before they have MRI to after they have MRI as assessed from patient medical records.[Treatment decision made immediately after having MRI.];The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients who require further breast surgery due to positive margins or suspected residual invasive or in situ disease as assessed from patient medical records..[At any time after primary surgery up to 2 years after registration..]