WithdrawnPhase 2

Radiotherapy in Combo With Chemo and Immunotherapy in Patients With PD-L1 Positive Metastatic TNBC

Stopped: Low Accrual

United States0Started 2022-01-04

Plain-language summary

Patients with locally advanced unresectable or metastatic programmed cell death ligand (PD-L1) positive triple negative breast cancer (TNBC) will be treated with radiation to one-four sites of metastasis amenable to radiation (sites of disease to be selected at the discretion of the treating radiation oncologist) followed by initiation of systemic therapy with pembrolizumab plus nab-paclitaxel/paclitaxel. Patients will be treated with pembrolizumab plus nab-paclitaxel/paclitaxel within 7 days of completion of radiation. Repeat imaging of all sites of disease will be performed every 9 weeks and response will be assessed according to RECIST 1.1.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Provision to sign and date the consent form including non-English speaking and non-reading participants.
✓. Stated willingness to comply with all study procedures and be available for the duration of the study.
✓. Male or female aged ≥ 18 years.
✓. Metastatic or locally advanced unresectable histologically documented TNBC as defined by absence of estrogen receptor (ER) and progesterone receptor (PR) expression and no HER2 amplification or over-expression by local pathology report.
✓. HER2 negativity is defined as either: in situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2 or single probe average HER2 gene copy number \< 4 signals/cell OR IHC 0 or 1+).
✓. ER and PR negativity is defined as \< 1% positive by IHC.
✓. Treatment with \< 1 prior line of systemic therapy in the metastatic setting or adjuvant/neoadjuvant setting if metastatic recurrence within 12 months of treatment.
✓. Confirmed PD-L1 positive as defined by Combined Positive Score (CPS) \> 10% by a CLIA-certified lab

Exclusion criteria

What they're measuring

1 year progression free survival rate

Timeframe: 36 months

Trial details

NCT IDNCT05233696

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

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