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
TROG 12.02 PET Scans for Locally Advanced Breast Cancer and Diagnostic MRI to Determine the Extent of Operation and Radiotherapy
TROG
220 participants
Mar 1, 2016
Interventional
Conditions
Summary
The primary purpose of this study is to investigate whether breast MRI and a PET-CT scan can accurately predict which women with locally advanced breast cancer (LABC) treated by initial Primary Systemic Treatment (PST), can undergo Breast Conserving Surgery (BCS), without compromising local control or Disease Free Survival. You may be eligible to join this study if you are over 18 years old, female, with Clinical Stage III (non-inflammatory) unilateral breast cancer. All patients receive PST as per local practice before operability is then assessed. MRI and PET-CT scan will be taken up to four times during the study; 1/pre-treatment, 2/between 4 and 5 weeks from start of PST, 3/between 3 and 5 weeks after PST is completed and 4/between 10 and12 weeks after radiotherapy treatment (for participants that are inoperable). Each MRI scan will take 20-40 minutes to complete. Each PET-CT takes 60-90 minutes to complete. * If LABC becomes operable, either mastectomy or BSC is performed as well as Sentinal Node Biopsy (SNB) and axillary node dissection. All patients receive radiotherapy 6-8 weeks post-operatively. * If LABC remains inoperable, radiotherapy is given to the breast and nodes. 5-7 weeks after completion of radiotherapy and the patient is re-assessed. If disease has become operable, mastectomy and axillary node dissection is performed. * All patients with a hormone sensitive tumour commence hormonal therapy 14 days after the completion of treatment to the breast and nodes. This study aims to find out if women with LABC can have BCS instead of mastectomy with a low chance of the cancer returning.
Eligibility
Inclusion Criteria17
- Cytological + / - Histological confirmation of disease within 28 days prior to registration
- Clinical Stage III (non-inflammatory) unilateral breast cancer
- 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
- Women must be suitable for radical treatment employing chemotherapy, surgery, radiation therapy + / - trastuzumab + / - hormonal therapy
- A ECOG performance status score of 1 or less within 28 days prior to registration
- No contraindications to receiving radiation treatment
- Life expectancy greater than 36 months
- Participants capable of childbearing are using adequate contraception.
- Available for follow up
- Patients may proceed to protocol treatment if they meet the following criteria:
- Adequate cardiac function as defined by a left ventricular ejection fraction of >50%, unless patient is enrolled on a study of primary endocrine therapy.
- Patients who have no metasteses on PET CT scan OR PET-CT scan identifies up to 3 sites of metastases only.
Exclusion Criteria10
- Women who are pregnant or lactating
- Women who are unwilling to have photographs taken of the area from the mid-neck to navel at specified time-points throughout the study.
- 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
- Clinical evidence of bilateral breast cancer
- Previous RT to the area to be treated
- Previous chemotherapy
- Previous surgery to the ipsilateral breast or nodes
- Previous contralateral breast cancer
- 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
- Patients with clinical evidence of metastatic disease.
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Interventions
The use of the medical imaging techniques of Breast Magnetic Resonance Imaging (MRI) and Positron emission tomography -computed tomography (PET-CT). MRI and PET-CT will be taken upto 4 times during the study, pre treatment, between 4 to 5 weeks from start of primary systemic treatment, between 3-5 weeks after primay systemic treament is completed and if applicable for inoperable participants, between 10-12 weeks after from radiotherapy treatment. Each MRI scan will take 20-40 minutes to complete. Each PET-CT takes 60-90 minutes to complete.
Locations(1)
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ACTRN12613000253707