TAORMINA: Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05377047

Collaborator

Sahlgrenska University Hospital, Sweden (Other), Azienda Ospedaliero-Universitaria Careggi (Other), Region Örebro County (Other), Skane University Hospital (Other), Uppsala University Hospital (Other), Karolinska University Hospital (Other), University Hospital, Umeå (Other), Sundsvall Hospital (Other), Karlstad Central Hospital (Other), Gävle Hospital (Other), Centrallasarettet Västerås (Other), Oslo University Hospital (Other), St. Olavs Hospital (Other), Haukeland University Hospital (Other), University of Stavanger (Other), University Hospital of North Norway (Other)

345

Enrollment

Arms

67.5

Anticipated Duration (Months)

Study Details

Study Description

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) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Stage IV Oligometastatic Disease	Radiation: SABR	N/A

Detailed Description

Patients with 1-5 metastases in 1-2 organs with any breast cancer subtype can be enrolled. All metastases must be available for SABR.

The primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve overall survival (OS).

Secondary aims are to compare progression-free survival (PFS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).

Exploratory analyses: Circulationg tumour DNA as early signs of disease progression.

Immun panel for determination of the effect of SABR on patients´ immune response.

To investigate the survival for each BC subtype (Luminal, HER2+ and TNBC)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

345 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental SABR arm Standard first line systemic therapy + SABR.	Radiation: SABR Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.
No Intervention: Control systemic therapy arm Standard first line systemic therapy.

Arm

Intervention/Treatment

Experimental: Experimental SABR arm

Standard first line systemic therapy + SABR.

Radiation: SABR

Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.

No Intervention: Control systemic therapy arm

Standard first line systemic therapy.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [3 years after the last patient inclusion]
Time from the date of randomisation to the date of death for any cause.

Secondary Outcome Measures

Progression-free survival (PFS) [3 years after the last patient inclusion]
Time from the date of randomisation to the date of disease progression
Local Control Rate (LCR) [3 years after the last patient inclusion]
Time from the date of randomisation to the date of progress in previously treated metastases
Safety analysis - acute toxicity [From the first dose of SABR to 3 months after the last dose of SABR]
Reported according to CTCAE v.5.0
Safety analysis - late toxicity [From the first dose of SABR to 3 years after the last dose of SABR]
Reported according to CTCAE v.5.0
Health-related quality of life Cancer-30 [3 years after the last patient inclusion]
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30)
Health-related quality of life Breast-23 [3 years after the last patient inclusion]
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically or cytological confirmed recurrent OMBC.
Age ≥18 years old.
OMBC defined as 1-5 metastases in a maximum of two organs.
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 Criteria:

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).

Contacts and Locations

Locations

No locations specified.

Investigators

Principal Investigator: Barbro K Linderholm, MD, PhD, Sahlgrenska University Hospital, Gothenburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vastra Gotaland Region

ClinicalTrials.gov Identifier:

NCT05377047

Other Study ID Numbers:

SABO 21-01

First Posted:

May 17, 2022

Last Update Posted:

May 17, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of May 17, 2022