NCT06489821Not yet recruiting
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)
Source: ClinicalTrials.gov · Last updated 8 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 1 Sept 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Juravinski Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06489821
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 1 Sept 2024 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
- Progression on 2nd line or subsequent lines of therapy
- Lacks CT or bone scan Imaging within previous 45 days;
- Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
Other illness
- Hormone positive disease on endocrine therapy only at time of enrollment;
- History of major radiosensitivity syndrome or contraindications to radiotherapy.
Other
- Progression in \>3 sites in the liver or lung;
- Lesions deemed not amenable to SBRT due to large size or location;
- Unacceptable fracture risk according to clinician judgement for bone lesions;
- Brain metastasis or Spinal cord compression;
Who the study is looking for
- Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
- Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
- Patients must have previously controlled disease for at least six months on current systemic therapy
- Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.