ETNA: Adjuvant pembrolizumab and chemotherapy or surveillance in Early Triple Negative breAst cancer with high stromal tumor-infiltrating lymphocytes (TILs) score

Conditions

Triple negative breast cancer

Brief summary

The primary endpoint is DDFS in cohort 1 and in cohort 2. DDFS is defined from the time from inclusion to the following events whichever comes first: distant recurrence of breast cancer, second primary non breast cancer, and death from any cause.

Detailed description

Efficacy - IDFS is defined from the time from inclusion to the following events whichever comes first : Ipsilateral invasive breast tumor recurrence; Regional invasive breast tumor recurrence; Distance recurrence; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause; Second primary malignancy., Efficacy - DRFS is defined from the time from inclusion to the following events whichever comes first: distant recurrence of breast cancer, and death from any cause., Efficacy - OS is defined as the time from inclusion to date of death from any cause., Safety - Cohort 1: Safety and tolerability of pembrolizumab plus paclitaxel will be measured, every 3 weeks while on treatment and thereafter every 6 months for 5 years from study entry, Quality of life assessment - QoL domains will be assessed using: EORTC QLQ-C30, EORTC QLQ-B23, EORTC QLQ-FA12, and HADS – anxiety subscale., Exploratory endpoints - Comprehensive exploratory analysis will be performed on tumor tissue (initial biopsy, surgery and recurrence biopsy) and blood samples.

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is DDFS in cohort 1 and in cohort 2. DDFS is defined from the time from inclusion to the following events whichever comes first: distant recurrence of breast cancer, second primary non breast cancer, and death from any cause.	—

Secondary

Measure	Time frame
Efficacy - IDFS is defined from the time from inclusion to the following events whichever comes first : Ipsilateral invasive breast tumor recurrence; Regional invasive breast tumor recurrence; Distance recurrence; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause; Second primary malignancy., Efficacy - DRFS is defined from the time from inclusion to the following events whichever comes first: distant recurrence of breast cancer, and death from any cause., Efficacy - OS is defined as the time from inclusion to date of death from any cause., Safety - Cohort 1: Safety and tolerability of pembrolizumab plus paclitaxel will be measured, every 3 weeks while on treatment and thereafter every 6 months for 5 years from study entry, Quality of life assessment - QoL domains will be assessed using: EORTC QLQ-C30, EORTC QLQ-B23, EORTC QLQ-FA12, and HADS – anxiety subscale., Exploratory endpoints - Comprehensive exploratory analysis will be performed on tu	—

Measure

Time frame

Efficacy - IDFS is defined from the time from inclusion to the following events whichever comes first : Ipsilateral invasive breast tumor recurrence; Regional invasive breast tumor recurrence; Distance recurrence; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause; Second primary malignancy., Efficacy - DRFS is defined from the time from inclusion to the following events whichever comes first: distant recurrence of breast cancer, and death from any cause., Efficacy - OS is defined as the time from inclusion to date of death from any cause., Safety - Cohort 1: Safety and tolerability of pembrolizumab plus paclitaxel will be measured, every 3 weeks while on treatment and thereafter every 6 months for 5 years from study entry, Quality of life assessment - QoL domains will be assessed using: EORTC QLQ-C30, EORTC QLQ-B23, EORTC QLQ-FA12, and HADS – anxiety subscale., Exploratory endpoints - Comprehensive exploratory analysis will be performed on tu

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Countries

France, Spain

Outcome results

None listed