Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed… (NCT02658812) | Clinical Trial Compass
TerminatedPhase 2
Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery
Stopped: Per PI
United States11 participantsStarted 2016-08-01
Plain-language summary
This phase II trial studies how well talimogene laherparepvec works in treating patients with breast cancer that has come back and cannot be removed by surgery. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histological confirmation of breast carcinoma
* Histological confirmation of recurrence of chest wall with or without distant metastasis disease
* Patients must have failed at least 1 systemic regimen or have clinical stable disease with capecitabine, hormonal therapy (with or without mTOR inhibitor or CDK4/6 inhibitor), or anti HER-2 therapy (trastuzumab, pertuzumab, ado-trastuzumab emtansine, lapatinib) for at least 2 months after their diagnosis of locoregional/metastatic disease
* Concurrent radiation therapy is permitted after the study treatment is initiated so long as the planned radiation field doesn't overlap with planned injection sites
* Eastern cooperative oncology group performance status (ECOG PS) 0-1
* Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L; if patient is taking CDK4/6 inhibitor or capecitabine, there is a need for maintaining ANC \>= 1.0 consistently for at least 2 months without dose changes
* Platelet count \>= 75 x 10\^9/L, if patient is taking CDK4/6 inhibitor, ado-trastuzumab emtansine or capecitabine, there is a need for maintaining platelet count \>= 75 x 10\^9/L without dose changes
* Hemoglobin \>= 8.0 g/L
* International normalization ratio (INR) or prothrombin time (PT) 1.5 x upper limit of normal (ULN), unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants
* Serum creatini…
What they're measuring
1
Number of Participants With Overall Response Rate (ORR)
Timeframe: at the end of cycle 4 , cycle 8, and cycle 10, up to 5 months