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NCT Number: NCT06489821

STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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;
  • Progression in >3 sites in the liver or lung;
  • Hormone positive disease on endocrine therapy only at time of enrollment;
  • Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
  • 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;
  • History of major radiosensitivity syndrome or contraindications to radiotherapy.

Treatment and study plan

stereotactic body radiotherapy

Radiation

Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy

Primary outcomes

  1. Percentage of patients with change in systemic therapy

    Time frame: Six months

    Change in systemic therapy will occur with progression with the following criteria:

    • Progression not amenable to further SBRT, including multifocal (>3) sites;
    • Progression in lesion not amenable to further SBRT;
    • Rapid progression such that treating medical oncologist believes change in therapy is warranted;
    • Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted

Secondary outcomes

  1. Progression-free survival

    Time frame: 3, 6, 12, 18, and 24 months

    Progression outside radiotherapy field per RECIST 1.1

  2. Local progression

    Time frame: 3, 6, 12, 18, and 24 months

    Progression within a treated lesion per RECIST 1.1

  3. Time to chemotherapy

    Time frame: 3, 6, 12, 18, and 24 months

    Initiation of cytotoxic therapy

  4. Overall Survival

    Time frame: 3, 6, 12, 18, and 24 months

    Proportion of patients alive

  5. CTCAE Toxicity

    Time frame: 3, 6, 12, 18, and 24 months

    common terminology criteria for adverse events 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Elysia K Donovan, MD MSc FRCPC DABR

CONTACT

[email protected]

905 387 9495 ext. 63123

Kyle McGowan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Juravinski Cancer Center

Other

Collaborators

  • Juravinski Cancer Centre Foundation

Registry information

Official study title

STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)

Acronym: STAR-B

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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