Trials / Completed
CompletedNCT03464942
Stereotactic Radiation and Immunotherapy in Patients With Advanced Triple Negative Breast Cancer
A Randomised Phase II Trial Comparing the Efficacy of Single-fraction or Multi-fraction SABR (Stereotactic Ablative Body Radiotherapy) With AteZolizumab in Patients With Advanced Triple nEgative Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Peter MacCallum Cancer Centre, Australia · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
- First posted
- 2018-03-14
- Last updated
- 2023-07-19
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03464942. Inclusion in this directory is not an endorsement.