A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Conditions

Triple Negative Breast Cancer (TNBC)

Brief summary

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, Event-free Survival (EFS) as assessed by Investigator

Detailed description

pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery, pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, EFS in participants with tumors expressing PD-L1, pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery, Overall survival (OS), Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score, EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score

Related papers

No related papers found yet.

Interventions

DRUGCYCLOPHOSPHAMIDE

DRUGPEGFILGRASTIM

DRUGEPIRUBICIN

DRUGPlacebo to keytruda-normal saline or dextrose

DRUGFILGRASTIM

DRUGDOXORUBICIN

DRUGPACLITAXEL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, Event-free Survival (EFS) as assessed by Investigator	—

Secondary

Measure	Time frame
pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery, pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, EFS in participants with tumors expressing PD-L1, pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery, Overall survival (OS), Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score, EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score	—

Measure

Time frame

pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery, pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, EFS in participants with tumors expressing PD-L1, pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery, Overall survival (OS), Percentage of participants who experience an adverse event (AE), Percentage of participants who discontinue study treatment due to an AE, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score, EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score

—

Countries

France, Germany, Ireland, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed