Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Launched by VASTRA GOTALAND REGION · May 11, 2022

Keywords

ClinConnect Summary

The TAORMINA trial is a research study looking at a treatment for patients with a specific type of breast cancer called oligometastatic breast cancer (OMBC), which means the cancer has spread to 1 to 5 places in up to two organs but is still considered manageable. This trial compares two approaches: one group will receive a special type of radiation therapy called stereotactic ablative radiotherapy (SABR) along with standard treatments, while the other group will only get the standard treatments. The goal is to see if adding SABR helps patients live longer or have a better quality of life.

To participate in this trial, patients need to be at least 18 years old and have confirmed recurrent OMBC. They should also have a controlled primary tumor and meet certain health criteria, such as having a life expectancy of more than 6 months. Patients will undergo regular evaluations and imaging tests, like PET-CT scans, to monitor their condition throughout the study. The trial is currently recruiting participants, and individuals interested should discuss their eligibility with their healthcare provider to learn more about the process and what to expect.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytological confirmed recurrent OMBC.
• • 2. Age ≥18 years old.
• • 3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
• • 4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
• • 5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
• • 6. Patients with local recurrence and OMBC must have a controlled local recurrence.
• • 7. ECOG/WHO 0-2.
• • 8. Life expectancy \> 6 months.
• • 9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
• • 10. If measurable lesions, each ≤ 5 cm.
• • 11. Symptomatic bone metastases are allowed if ablative therapy can be delivered (femoral metastasis not allowed).
• • 12. Adequate organ function for the planned treatment according to local guide-lines.
• 13. 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.
• • 14. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \> 60mL/min.
• • 15. 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.
• • 16. Negative pregnancy test within 14 days prior to start of treatment\*.
• • 17. If childbearing potential, willing to use an effective form of contraception\*.
• • 18. 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.
• • 19. Signed informed consent and willingness to follow the trial procedures.
• Exclusion Criteria:
• • 1. \> 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).
• • 2. Oligometastases in brain.
• • 3. Malignant pleural effusion or ascites.
• • 4. 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.
• • 5. Unable to undergo imaging by either CT scan or MRI.
• • 6. 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.
• • 7. Pregnancy or breast-feeding.
• • 8. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).