Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Contact Information
Primary
Katarzyna Kulbacka-Ortiz, CTO
katarzyna.kulbacka-ortiz@vgregion.se
+46721470685
Backup
Annika Baan
annika.baan@vgregion.se
+46700906097
Time Frame
Start Date: 2022-09-19
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 345
Treatments
Experimental: Experimental SABR arm
Standard first line systemic therapy + SABR.
No_intervention: Control systemic therapy arm
Standard first line systemic therapy.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Umeå, Sundsvall Hospital, Centrallasarettet Västerås, Karolinska University Hospital, Uppsala University Hospital, Gävle Hospital, Skane University Hospital, University of Stavanger, University Hospital of North Norway, Azienda Ospedaliero-Universitaria Careggi, St. Olavs Hospital, Karlstad Central Hospital, Haukeland University Hospital, Region Örebro County, Oslo University Hospital, Sahlgrenska University Hospital
Leads: Vastra Gotaland Region

This content was sourced from clinicaltrials.gov