STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer (STAR-B)

July 4, 2024 updated by: Elysia Donovan, Juravinski Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Elysia K Donovan, MD MSc FRCPC DABR
  • Phone Number: 63123 905 387 9495
  • Email: donovane@hhsc.ca

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patients must have previously controlled disease for at least six months on current systemic therapy
  4. Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions

Exclusion Criteria:

  1. Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
  2. Progression on 2nd line or subsequent lines of therapy
  3. Lacks CT or bone scan Imaging within previous 45 days;
  4. Progression in >3 sites in the liver or lung;
  5. Hormone positive disease on endocrine therapy only at time of enrollment;
  6. Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
  7. Lesions deemed not amenable to SBRT due to large size or location;
  8. Unacceptable fracture risk according to clinician judgement for bone lesions;
  9. Brain metastasis or Spinal cord compression;
  10. History of major radiosensitivity syndrome or contraindications to radiotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy
SBRT in 5 or 2 (or 4) fractions for body and spine respectively over 2 weeks, while continuing first line systemic therapy
Radiation: Stereotactic body radiotherapy
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with change in systemic therapy
Time Frame: Six months

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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3, 6, 12, 18, and 24 months
Progression outside radiotherapy field per RECIST 1.1
3, 6, 12, 18, and 24 months
Local progression
Time Frame: 3, 6, 12, 18, and 24 months
Progression within a treated lesion per RECIST 1.1
3, 6, 12, 18, and 24 months
Time to chemotherapy
Time Frame: 3, 6, 12, 18, and 24 months
Initiation of cytotoxic therapy
3, 6, 12, 18, and 24 months
Overall Survival
Time Frame: 3, 6, 12, 18, and 24 months
Proportion of patients alive
3, 6, 12, 18, and 24 months
CTCAE Toxicity
Time Frame: 3, 6, 12, 18, and 24 months
common terminology criteria for adverse events 5.0
3, 6, 12, 18, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juravinski Cancer Center

Collaborators

Juravinski Cancer Centre Foundation

Investigators

  • Study Director: Kyle McGowan, Juravinski CC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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