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

Sponsor
Peter MacCallum Cancer Centre, Australia
Study ID
NCT03464942
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SABR — RADIATION
    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.
  • Atezolizumab — DRUG
    All participants will commence atezolizumab (within 5 days of last SABR dose) 1200 mg every 3 weeks for 24 months

Study Details

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.

Key Dates

Start date
Aug 1, 2018
Status verified
Jul 2023
Primary completion
Jun 22, 2023
Completion
Jun 22, 2023

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Single Dose
    SABR 20Gy given as a single dose (to 1 -4 metastases with at least 1 untreated metastasis) followed by atezolizumab (1200 mg) every 3 weeks for 24 months.
  • Active Comparator: Fractionated Dose
    SABR 24Gy given as 3 fractions (to 1 -4 metastases with at least 1 untreated metastasis) followed by atezolizumab (1200 mg) every 3 weeks for 24 months.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 24 months ]

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