Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078384
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-10-05
Brief Title:
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes TILs Score
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETNA
Brief Summary:
Triple-negative breast cancer TNBC is a group of tumors that occurs mainly in young premenopausal women and accounts for 10-20 of breast cancers Over the past decade the incidence of women diagnosed with early-stage TNBC has significantly increased due to the widespread use of screening mammography Treatment of patients with localized TNBC mainly involves surgery and neoadjuvant chemotherapy with or without radiotherapy However the benefit of chemotherapy may be controversial in patients with early-stage TNBC defined by small size and absence of lymph node involvement and with significant tumor lymphocyte infiltration
The ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1bc N0M0 and stromal TILs sTILs 30 ETNA comprises two cohorts defined according to the level of TILs and the age of patients Patients aged 40 years with 30 sTILs 50 and those aged 40 years with 30 sTILs 75 will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mgm² weekly for 12 cycles Patients aged 40 years with sTILs 50 and those aged 40 years with sTILs 75 will be included in cohort 2 and will not receive adjuvant treatment they will undergo standard surveillance every six months
The ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1bc N0M0 and stromal TILs sTILs 30 ETNA comprises two cohorts defined according to the level of TILs and the age of patients Patients aged 40 years with 30 sTILs 50 and those aged 40 years with 30 sTILs 75 will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mgm² weekly for 12 cycles Patients aged 40 years with sTILs 50 and those aged 40 years with sTILs 75 will be included in cohort 2 and will not receive adjuvant treatment they will undergo standard surveillance every six months
Detailed Description:
Neoadjuvant chemotherapy in breast cancer is associated to long-term persistent QoL deterioration in patients with early breast cancer with a greater negative impact in patients that were premenopausal at diagnosis Because triple negative breast cancer TNBC which accounts for 10-20 of breast cancers presents a poorer prognosis as compared to the other subtypes international guidelines endorse the use of adjuvant chemotherapy from TNBC tumors measuring 5 mm Nevertheless a number of retrospective studies have reported excellent prognosis for patients with small lymph node-negative and high TILs TNBC even without chemotherapy with 5-year overall survival OS of 98 Findings from multiple data sets consistently demonstrated that TILs represent a robust prognostic and predictive biomarker in early-stage TNBC being now the first biological prognostic marker for TNBC included in several international guidelines for early-stage disease such as 2019 St Gallen consensus conference and European Society for Medical Oncology ESMO Guidelines for early-stage breast cancer
In clinical practice oncologists have taken different approaches in patients with stage I TNBC While some have de-escalated anthracyclines other did not held back on the standard chemotherapy options with anthracyclines taxanes and cyclophosphamide Based on unpublished data from the TNBC pooled analysis with sTILs on 2211 patients not treated by systematic therapy performed at Gustave Roussy the 5-year distant disease free-survival DDFS is 87 91 and 93 for those with stage I and sTILs 30 50 and 75 respectively Given these compelling findings from historical observations it is reasonable to anticipate that the absolute benefit of chemotherapy would be modest among these patients as their tumors generally exhibit a favorable prognosis resulting in reduced benefits with the use of adjuvant chemotherapy
ETNA is a phase II multicenter biomarker-driven study that is designed to characterize the clinical course of patients with stage I TNBC and sTILs 30
ETNA includes patients with stage I and sTILs 30 TNBC in 2 cohorts
Cohort 1 will include patients age 40 years with 30 sTILs 50 and those aged 40 years with 30 sTILs 75 Patients will receive 9 cycles of adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mgm² weekly for 12 cycles
Cohort 2 will include patients aged 40 years with sTILs 50 and those aged 40 years with sTILs 75 who will undergo standard surveillance no adjuvant systemic treatments
In clinical practice oncologists have taken different approaches in patients with stage I TNBC While some have de-escalated anthracyclines other did not held back on the standard chemotherapy options with anthracyclines taxanes and cyclophosphamide Based on unpublished data from the TNBC pooled analysis with sTILs on 2211 patients not treated by systematic therapy performed at Gustave Roussy the 5-year distant disease free-survival DDFS is 87 91 and 93 for those with stage I and sTILs 30 50 and 75 respectively Given these compelling findings from historical observations it is reasonable to anticipate that the absolute benefit of chemotherapy would be modest among these patients as their tumors generally exhibit a favorable prognosis resulting in reduced benefits with the use of adjuvant chemotherapy
ETNA is a phase II multicenter biomarker-driven study that is designed to characterize the clinical course of patients with stage I TNBC and sTILs 30
ETNA includes patients with stage I and sTILs 30 TNBC in 2 cohorts
Cohort 1 will include patients age 40 years with 30 sTILs 50 and those aged 40 years with 30 sTILs 75 Patients will receive 9 cycles of adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mgm² weekly for 12 cycles
Cohort 2 will include patients aged 40 years with sTILs 50 and those aged 40 years with sTILs 75 who will undergo standard surveillance no adjuvant systemic treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504620-26-00 | OTHER | EU Clinical Trials Register | None |