Status:
RECRUITING
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Sahlgrenska University Hospital
Azienda Ospedaliero-Universitaria Careggi
Conditions:
Breast Cancer Stage IV
Oligometastatic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) ...
Detailed Description
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) ...
Eligibility Criteria
Inclusion
- Histologically or cytological confirmed recurrent OMBC.
- Age ≥18 years old.
- OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
- Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
- Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
- Patients with local recurrence and OMBC must have a controlled local recurrence.
- ECOG/WHO 0-2.
- Life expectancy \> 6 months.
- Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
- If measurable lesions, each ≤ 5 cm.
- Symptomatic bone metastases are allowed if ablative therapy can be delivered (femoral metastasis not allowed).
- Adequate organ function for the planned treatment according to local guide-lines.
- For patients with liver metastasis:
- No cirrhosis or hepatitis
- Hepatic function:
- Total bilirubin level \< 3.0 x institutional ULN
- ALT, AST, GGT, and alkaline phosphatase levels \< 3.0 x institutional ULN
- Albumin \> 2.5 mg/dL
- Metastasis not adjutant to stomach or small bowel.
- For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \> 60mL/min.
- Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.
- Negative pregnancy test within 14 days prior to start of treatment\*.
- If childbearing potential, willing to use an effective form of contraception\*.
- No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
- Signed informed consent and willingness to follow the trial procedures.
Exclusion
- \> 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included).
- Oligometastases in brain.
- Malignant pleural effusion or ascites.
- Metastasis growth that involves \> 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit.
- Unable to undergo imaging by either CT scan or MRI.
- Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
- Pregnancy or breast-feeding.
- Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT05377047
Start Date
September 19 2022
End Date
December 31 2027
Last Update
October 21 2022
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, Sweden, 41345