Impact of neoadjuvant immunotherapy in early stage breast cancer before standard therapy (BIS-Program)

Conditions

Newly diagnosed, non-metastatic early-stage triple-negative or HER2+ breast cancer

Brief summary

Presence/ of two-fold increase in GzmB+ CD8+ T cell levels from baseline to post-treatment window in biopsies.

Detailed description

Changes in CD8+, PD-L1, MHC-I and % of Ki67 expression from baseline (pre-study) to end of study-treatment biopsies, Changes from baseline tumor tissue to end of treatment in immune infiltrates, immune-related gene expression, Incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 4 weeks post-surgery, Clinical response after experimental therapy, defined as a > 30% decrease in tumor diameter from baseline breast ultrasound based on investigator assessment, pCR defined as the absence of any residual invasive cancer based on histological evaluation of the resected specimen during definitive breast cancer surgery, Rate of anti-Pembrolizumab antibodies at day 1 of cycle 2 Pembrolizumab (only patients in TNBC cohort, who will have Pembrolizumab as neoadjuvant systemic treatment).

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPerjeta 420 mg concentrate for solution for infusion

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGTecentriq 840 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Presence/ of two-fold increase in GzmB+ CD8+ T cell levels from baseline to post-treatment window in biopsies.	—

Secondary

Measure	Time frame
Changes in CD8+, PD-L1, MHC-I and % of Ki67 expression from baseline (pre-study) to end of study-treatment biopsies, Changes from baseline tumor tissue to end of treatment in immune infiltrates, immune-related gene expression, Incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 4 weeks post-surgery, Clinical response after experimental therapy, defined as a > 30% decrease in tumor diameter from baseline breast ultrasound based on investigator assessment, pCR defined as the absence of any residual invasive cancer based on histological evaluation of the resected specimen during definitive breast cancer surgery, Rate of anti-Pembrolizumab antibodies at day 1 of cycle 2 Pembrolizumab (only patients in TNBC cohort, who will have Pembrolizumab as neoadjuvant systemic treatment).	—

Measure

Time frame

Changes in CD8+, PD-L1, MHC-I and % of Ki67 expression from baseline (pre-study) to end of study-treatment biopsies, Changes from baseline tumor tissue to end of treatment in immune infiltrates, immune-related gene expression, Incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 4 weeks post-surgery, Clinical response after experimental therapy, defined as a > 30% decrease in tumor diameter from baseline breast ultrasound based on investigator assessment, pCR defined as the absence of any residual invasive cancer based on histological evaluation of the resected specimen during definitive breast cancer surgery, Rate of anti-Pembrolizumab antibodies at day 1 of cycle 2 Pembrolizumab (only patients in TNBC cohort, who will have Pembrolizumab as neoadjuvant systemic treatment).

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Countries

France

Outcome results

None listed