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Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer

NCT03464942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-07-19

No results posted yet for this study

Summary

This is a multi-centre, open label, phase 2, randomised controlled trial of patients with advanced triple negative breast cancer (TNBC) who have received no more than one line of chemotherapy (not including neoadjuvant or adjuvant therapy) who will be randomised to be treated with SABR 20Gy in 1# followed by atezolizumab or SABR 24Gy in 3# followed by atezolizumab.

Conditions

Interventions

RADIATION

SABR

Single Dose Group: this group will receive 20 Gy of radiation in a single dose within 10 days of randomisation Fractionated Dose: Participants in this dose will receive a total of 24Gy of radiation given as 3 separate fractions of 8 Gy each.

DRUG

Atezolizumab

All participants will commence atezolizumab (within 5 days of last SABR dose) 1200 mg every 3 weeks for 24 months

Sponsors & Collaborators

  • Trans Tasman Radiation Oncology Group

    collaborator OTHER

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Sherene Loi, Prof · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2023-06-22
Completion
2023-06-22

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03464942 on ClinicalTrials.gov