TROG 12.02: Positron Emission Tomography (PET) Scans for Locally Advanced Breast Cancer and Diagnostic Magnetic Resonance Imaging (MRI) to Determine the Extent of Operation and Radiotherapy

Phase 2

Active, not recruiting

• Conditions: ocally Advanced Breast Cancer; Locally Advanced Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12613000253707
• Lead Sponsor: TROG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-04
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

1. Cytological + / - Histological confirmation of disease within 28 days prior to registration
2. Clinical Stage III (non-inflammatory) unilateral breast cancer
3. Adequate haematological, renal and hepatic function as defined by:
a) Absolute neutrophil count (ANC, segs + bands) > / =1.5 x 109 / L
b) Platelet count > / = 100 x 109 / L
c) Total Bilirubin > / = 1.5 x upper normal limit
d) Alaninie aminotransferase (ALT) < / = 2.5 x upper normal limit
e) EGFR >30ml/min
4. Women must be suitable for radical treatment employing chemotherapy, surgery, radiation therapy + / - trastuzumab + / - hormonal therapy
5. A ECOG performance status score of 1 or less within 28 days prior to registration
6. No contraindications to receiving radiation treatment
7. Life expectancy greater than 36 months
8. Participants capable of childbearing are using adequate contraception.
9. Available for follow up

Patients may proceed to protocol treatment if they meet the following criteria:
10. Adequate cardiac function as defined by a left ventricular ejection fraction of >50%, unless patient is enrolled on a study of primary endocrine therapy.
11. Patients who have no metasteses on PET CT scan OR PET-CT scan identifies up to 3 sites of metastases only.

Exclusion Criteria

1. Women who are pregnant or lactating
2. Women who are unwilling to have photographs taken of the area from the mid-neck to navel at specified time-points throughout the study.
3. Women with implanted medical or electronic devices deemed by the MRI radiologist to be a contra-indication to performing a breast MRI, for example: implanted defibrillator, cardiac pacemaker, a cochlear implant, implanted drug infusion port, a metallic joint prosthesis, nerve stimulators, metal pins, screws, plates, stents or surgical staples
4. Clinical evidence of bilateral breast cancer
5. Previous RT to the area to be treated
6. Previous chemotherapy
7. Previous surgery to the ipsilateral breast or nodes
8. Previous contralateral breast cancer
9. Prior diagnosis of cancer with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10% within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
10. Patients with clinical evidence of metastatic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to demonstrate a local recurrence rate of < or = 20% at three years in patients who undergo Breast Conserving Surgery (BCS) based on histopathology, MRI and PET-CT scans.[Three and Five years post registration]