Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer (TAORMINA)
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|ClinicalTrials.gov Identifier: NCT05377047|
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : October 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage IV Oligometastatic Disease||Radiation: SABR||Not Applicable|
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.
Patients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) 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 progression-free survival (PFS).
Secondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).
Circulating tumour DNA as an early sign 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). To investigate survival in patients with de novo OMBC and recurrent OMBC respectively.
Stratifications are based on subtype (luminal, HER2-positive vs TNBC) and type of OMBC (de novo vs. recurrent) without formal sample size calculation for the stratification factor (exploratory analysis).
Patients with de novo metastatic OMBC that is planned for neoadjuvant treatment are recommended to complete treatment followed by standard surgery and radiotherapy or SABR towards the primary tumour lesion(s).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomisation 2:1 (systemic treatment + SABR vs systemic treatment)|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 19, 2022|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2027|
Experimental: Experimental SABR arm
Standard first line systemic therapy + SABR.
Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions.
No Intervention: Control systemic therapy arm
Standard first line systemic therapy.
- Progression-free survival (PFS) [ Time Frame: 3 years after the last patient inclusion ]Time from the date of randomisation to the date of disease-progression at any site or death from any cause.
- Overall survival (OS) [ Time Frame: 3 years after the last patient inclusion ]Time from the date of randomisation to the date of death from any cause.
- Local Control Rate (LCR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration. ]European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30)
- Health-related quality of life Breast-23 [ Time Frame: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration. ]European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
- > 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05377047
|Contact: Katarzyna Kulbacka-Ortiz, CTOfirstname.lastname@example.org|
|Contact: Annika Baanemail@example.com|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Västra Götalandsregionen, Sweden, 41345|
|Contact: Barbro Kristina Linderholm, P.I. 0313427941 firstname.lastname@example.org|
|Principal Investigator:||Barbro K Linderholm, MD, PhD||Sahlgrenska University Hospital, Gothenburg|
|Responsible Party:||Vastra Gotaland Region|
|Other Study ID Numbers:||
|First Posted:||May 17, 2022 Key Record Dates|
|Last Update Posted:||October 21, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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