Breast Cancer Stage IV Clinical Trial
— TAORMINAOfficial 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
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.
Status | Recruiting |
Enrollment | 345 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg | Västra Götalandsregionen |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Azienda Ospedaliero-Universitaria Careggi, Centrallasarettet Västerås, Gävle Hospital, Haukeland University Hospital, Karlstad Central Hospital, Karolinska University Hospital, Oslo University Hospital, Region Örebro County, Sahlgrenska University Hospital, Sweden, Skane University Hospital, St. Olavs Hospital, Sundsvall Hospital, University Hospital of North Norway, University Hospital, Umeå, University of Stavanger, Uppsala University Hospital |
Sweden,
David S, Tan J, Savas P, Bressel M, Kelly D, Foroudi F, Loi S, Siva S. Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. Breast. 2020 Feb;49:55-62. doi: 10.1016/j.breast.2019.10.016. — View Citation
Li MP, Kelly D, Tan J, Siva S, Kron T, David S. Single-fraction stereotactic ablative body radiotherapy for sternal metastases in oligometastatic breast cancer: Technique and single institution experience. J Med Imaging Radiat Oncol. 2020 Aug;64(4):580-58 — View Citation
Milano MT, Katz AW, Zhang H, Huggins CF, Aujla KS, Okunieff P. Oligometastatic breast cancer treated with hypofractionated stereotactic radiotherapy: Some patients survive longer than a decade. Radiother Oncol. 2019 Feb;131:45-51. doi: 10.1016/j.radonc.20 — View Citation
Milano MT, Katz AW, Zhang H, Okunieff P. Oligometastases treated with stereotactic body radiotherapy: long-term follow-up of prospective study. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):878-86. doi: 10.1016/j.ijrobp.2011.08.036. Epub 2011 Dec 13. — View Citation
Milano MT, Zhang H, Metcalfe SK, Muhs AG, Okunieff P. Oligometastatic breast cancer treated with curative-intent stereotactic body radiation therapy. Breast Cancer Res Treat. 2009 Jun;115(3):601-8. doi: 10.1007/s10549-008-0157-4. Epub 2008 Aug 22. — View Citation
Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotact — View Citation
Scorsetti M, Franceschini D, De Rose F, Comito T, Villa E, Iftode C, Navarria P, D'Agostino GR, Masci G, Torrisi R, Testori A, Tinterri C, Santoro A. Stereotactic body radiation therapy: A promising chance for oligometastatic breast cancer. Breast. 2016 A — View Citation
Trovo M, Furlan C, Polesel J, Fiorica F, Arcangeli S, Giaj-Levra N, Alongi F, Del Conte A, Militello L, Muraro E, Martorelli D, Spazzapan S, Berretta M. Radical radiation therapy for oligometastatic breast cancer: Results of a prospective phase II trial. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | Time from the date of randomisation to the date of disease-progression at any site or death from any cause. | 3 years after the last patient inclusion | |
Secondary | Overall survival (OS) | Time from the date of randomisation to the date of death from any cause. | 3 years after the last patient inclusion | |
Secondary | Local Control Rate (LCR) | Time from the date of randomisation to the date of progress in previously treated metastases | 3 years after the last patient inclusion | |
Secondary | Safety analysis - acute toxicity | Reported according to CTCAE v.5.0 | From the first dose of SABR to 3 months after the last dose of SABR | |
Secondary | Safety analysis - late toxicity | Reported according to CTCAE v.5.0 | From the first dose of SABR to 3 years after the last dose of SABR | |
Secondary | Health-related quality of life Cancer-30 | European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30) | At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration. | |
Secondary | Health-related quality of life Breast-23 | European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23) | At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration. |
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