Actively Recruiting
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Led by Vastra Gotaland Region · Updated on 2022-10-21
345
Participants Needed
1
Research Sites
275 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
CONDITIONS
Official Title
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent oligometastatic breast cancer (OMBC).
- Age 18 years or older.
- OMBC defined as 1 to 5 metastases in a maximum of two organs confirmed by PET-CT.
- Patients on first-line systemic treatment with stable disease can be enrolled.
- Patients with de novo stage IV OMBC must have a controlled primary tumor.
- Patients with local recurrence and OMBC must have controlled local recurrence.
- ECOG/WHO performance status of 0 to 2.
- Life expectancy greater than 6 months.
- Known estrogen receptor, progesterone receptor, and HER2 status of primary tumor or metastasis.
- Measurable lesions must be 5 cm or smaller.
- Symptomatic bone metastases allowed if ablative therapy can be delivered (except femoral metastasis).
- Adequate organ function for planned treatment as per local guidelines.
- For liver metastasis: no cirrhosis or hepatitis, bilirubin less than 3 times upper limit of normal (ULN), ALT, AST, GGT, and alkaline phosphatase less than 3 times ULN, albumin more than 2.5 mg/dL, and metastasis not adjacent to stomach or small bowel.
- For abdominal metastases: renal function with creatinine clearance greater than 60 mL/min.
- Toxicities from previous adjuvant therapies recovered to grade 1 (except alopecia); stable grade 2 peripheral neuropathy considered individually.
- Negative pregnancy test within 14 days before treatment start.
- Willingness to use effective contraception if of childbearing potential.
- No other malignancy in the past 5 years except treated basal or squamous cell carcinoma of skin or carcinoma in situ of cervix.
- Signed informed consent and willingness to follow trial procedures.
You will not qualify if you...
- More than one line of systemic treatment for OMBC due to progressing disease (isolated local recurrences with 2nd adjuvant treatment excluded).
- Oligometastases in the brain.
- Malignant pleural effusion or ascites.
- Metastasis involving more than 3 vertebrae with spinal cord involvement, spine instability, neurological deficits, or 25% spinal canal compromise.
- Unable to undergo CT scan or MRI imaging.
- Medical conditions interfering with treatment or compliance (psychiatric illness, infections, neurological conditions, abnormal exam or labs).
- Pregnancy or breastfeeding.
- Concurrent malignancy requiring therapy except non-invasive carcinoma or carcinoma in situ.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, Sweden, 41345
Actively Recruiting
Research Team
K
Katarzyna Kulbacka-Ortiz, CTO
CONTACT
A
Annika Baan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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