CAPPA : A Phase II study to evaluate CAPecitabine plus Pembrolizumab as postoperative Adjuvant therapy for Triple Negative Breast Cancer with residual disease after neoadjuvant chemo-immunotherapy

Conditions

Triple Negative Breast Cancer with residual disease after neoadjuvant chemo-immunotherapy.

Brief summary

2-year Invasive disease free survival (iDFS).

Detailed description

Efficacy: Overall Survival (OS) is defined as the time from the date of inclusion to the date of death due to any cause. For patients alive, OS will be censored at date of last contact., Efficacy: Distant disease-free survival (DDFS) is defined as the time from the date of inclusion to the date of distant relapse or death due to any cause. For patients alive without distant relapse, DDFS will be censored at date of last contact., Efficacy : iDFS, OS and DDFS will also be compared to the external cohort of TNBC patients without pCR after NAC and treated with adjuvant pembrolizumab as part of standard of care after surgery, Safety : Safety and tolerability assessed by Adverse Events (AEs) as per the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0).

Related papers

No related papers found yet.

Interventions

DRUGCAPECITABINE

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
2-year Invasive disease free survival (iDFS).	—

Secondary

Measure	Time frame
Efficacy: Overall Survival (OS) is defined as the time from the date of inclusion to the date of death due to any cause. For patients alive, OS will be censored at date of last contact., Efficacy: Distant disease-free survival (DDFS) is defined as the time from the date of inclusion to the date of distant relapse or death due to any cause. For patients alive without distant relapse, DDFS will be censored at date of last contact., Efficacy : iDFS, OS and DDFS will also be compared to the external cohort of TNBC patients without pCR after NAC and treated with adjuvant pembrolizumab as part of standard of care after surgery, Safety : Safety and tolerability assessed by Adverse Events (AEs) as per the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0).	—

Measure

Time frame

Efficacy: Overall Survival (OS) is defined as the time from the date of inclusion to the date of death due to any cause. For patients alive, OS will be censored at date of last contact., Efficacy: Distant disease-free survival (DDFS) is defined as the time from the date of inclusion to the date of distant relapse or death due to any cause. For patients alive without distant relapse, DDFS will be censored at date of last contact., Efficacy : iDFS, OS and DDFS will also be compared to the external cohort of TNBC patients without pCR after NAC and treated with adjuvant pembrolizumab as part of standard of care after surgery, Safety : Safety and tolerability assessed by Adverse Events (AEs) as per the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0).

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Countries

France

Outcome results

None listed