Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
NCT ID: NCT06078384
Last Updated: 2025-11-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
354 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-12-27
Study Completion Date
2032-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 (neo)adjuvant 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 T1b/c 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 mg/m² 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 T1b/c 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 mg/m² 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Pembrolizumab(Pbr)/Nab-Paclitaxel Followed by Pbr/Epirubicin/Cyclophosphamide in TNBC
NCT03289819
Malignant Neoplasm of Breast
COMPLETED
PHASE2
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
NCT07178730
Breast Cancer
Triple-negative Breast Cancer
NOT_YET_RECRUITING
PHASE3
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
NCT06976944
Recurrent Triple-Negative Breast Cancer
RECRUITING
PHASE2
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
NCT05852691
Breast Cancer
ACTIVE_NOT_RECRUITING
PHASE2
Association of Pembrolizumab Infusion Time and Efficacy in Patients With Non-metastatic Triple-negative Breast Cancer (TNBC) Treated With Neoadjuvant Chemotherapy and Immunotherapy
NCT06418139
Non-Metastatic Breast Carcinoma
NOT_YET_RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
(Neo)adjuvant 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 mg/m² 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 mg/m² 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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Triple-negative Breast Cancer
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Cohort of patients with T1b/c N0 M0 TNBC aged \> 40 years with 30% ≤ sTILs \< 50% and those aged ≤ 40 years with 30% ≤ sTILs \< 75%: Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles at adjuvant phase of the treatment; Cohort of patients with T1b/c N0 M0 TNBC aged \> 40 years and sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%: No treatment will be administered. These patients will undergo standard surveillance every 6 months according to local practice.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1-Pembrolizumab plus Paclitaxel
Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles
Group Type
EXPERIMENTAL
Pembrolizumab 25 mg/ml
Intervention Type
DRUG
Pembrolizumab drug product is a sterile-filtered liquid and is aseptically filled into single-use vials.
The vials contain 4 mL of sterile solution for IV infusion.
Paclitaxel injection
Intervention Type
DRUG
Injectable solution for IV administration. Dose of 80 mg/m² weekly.
Cohort 2-Observation
No treatment will be administered, patients will undergo standard surveillance every 6 months according to local practice.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pembrolizumab 25 mg/ml
Pembrolizumab drug product is a sterile-filtered liquid and is aseptically filled into single-use vials.
The vials contain 4 mL of sterile solution for IV infusion.
Intervention Type
DRUG
Paclitaxel injection
Injectable solution for IV administration. Dose of 80 mg/m² weekly.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
keytruda
Taxol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Understand, sign, and date the written informed consent form prior to any protocol- specific procedures performed,
2. Men and women aged ≥ 18 years,
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
4. Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version,
* Histologically documented TNBC (negative HER2, ER, and PgR status). HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO/CAP criteria and ER/PgR negativity is defined by local laboratory assessment \< 10% using immunohistochemistry assays,
* Bilateral and/or multifocal primary tumor is allowed and the tumor with the most advanced T stage should be used to asses for eligibility. If multifocal tumor, a pathologic confirmation of TNBC is required for each focus,
5. Adequately excised breast cancer: subjects must have undergone either breast- conserving surgery or mastectomy/nipple- or skin-sparing mastectomy.
* For subjects who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. Reresections to ensure no ink on tumor margins are allowed. Subjects with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
* For subjects who undergo mastectomy/nipple- or skin-sparing mastectomy, margins must be free of gross residual tumor. It is recommended that subjects should have a negative microscopic margin in accordance with local pathology protocol,
6. Have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) for evaluation of pathologic nodal status.
Axillary nodal dissection(s) should yield a total of at least six nodes (including the axillary lymph nodes resected at the SLNB plus the lymph nodes collected at the axillary nodal dissection),
7. At least 4 weeks but no more than 12 weeks between definitive breast surgery (or the last surgery with curative intent if additional resection is required for breast cancer) and treatment initiation for cohort 1 and no more than 12 weeks for cohort 2,
8. Centrally assessed TILs score from surgical formalin-fixed paraffin embedded (FFPE) tumor sample, using an H\&E stained diagnostic digital slide, according to the most recent International TILs Working Group guidelines,
* Cohort 1 will include patients aged \> 40 years with 30% ≤ sTILs \< 50% and those aged
* 40 years with 30% ≤ sTILs \< 75%
* Cohort 2 will include patients aged \> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%
9. Women of childbearing potential have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication for cohort 1 and within 7 days of inclusion for cohort 2,
10. Women of childbearing potential must agree to use protocol-specified method(s) of contraception for 3 years after patient inclusion. Men subjects who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments.
Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year,
11. Patients affiliated to the social security system (or equivalent)- France only,
12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
13. Left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by echocardiogram or cardiac scintigraphy,
14. Demonstrate adequate organ function within 7 days of inclusion
* Absolute Neutrophil Count (ANC) ≥ 1,500 /µL
* Platelets ≥ 100,000 /µL
* Hemoglobin ≥ 9 g/dL
* Creatinine clearance ≥ 30 mL/min for subject with creatinine levels \> 1.5 x institutional upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Albumin ≥ 3.0 g/dL
* Lactate dehydrogenase (LDH) \< 2.5 X ULN
* International normalized ratio/partial thromboplastin time (INR/PTT) ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or PTT is within therapeutic range of intended use of anticoagulants)
* Thyroid stimulating hormone (TSH), free T4 (FT4), and free T3 (FT3) within normal ranges
* Cortisol at 8 AM within normal ranges
* Lipase and amylase \< 3 ULN
* Fasting plasma glucose ≤ 120 mg/dl or 6.7 mmol/L
* Troponin within normal range
16. Has cardiac dysfunction as defined by any of the following prior to inclusion:
* History of NCI-CTCAE v5.0 Grade \> 3 symptomatic congestive heart failure or New York Heart Association (NYHA) criteria Class II,
* Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease,
* Significant symptoms (≥ Grade 2) relating to left ventricular dysfunction or cardiac ischemia,
17. Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy or its analogs,
18. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment,
19. Concurrent active Hepatitis B virus (HBV; defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (HCV; defined as anti-HCV Ab positive and detectable HCV RNA) infection,
20. Severe infections within 4 weeks prior to initiation of study treatment, including, hospitalization for complications of infection, bacteremia, or severe pneumonia,
21. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; subjects receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible,
22. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment,
23. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has a current pneumonitis/interstitial lung disease,
24. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.
2. Men and women aged ≥ 18 years,
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
4. Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version,
* Histologically documented TNBC (negative HER2, ER, and PgR status). HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO/CAP criteria and ER/PgR negativity is defined by local laboratory assessment \< 10% using immunohistochemistry assays,
* Bilateral and/or multifocal primary tumor is allowed and the tumor with the most advanced T stage should be used to asses for eligibility. If multifocal tumor, a pathologic confirmation of TNBC is required for each focus,
5. Adequately excised breast cancer: subjects must have undergone either breast- conserving surgery or mastectomy/nipple- or skin-sparing mastectomy.
* For subjects who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. Reresections to ensure no ink on tumor margins are allowed. Subjects with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
* For subjects who undergo mastectomy/nipple- or skin-sparing mastectomy, margins must be free of gross residual tumor. It is recommended that subjects should have a negative microscopic margin in accordance with local pathology protocol,
6. Have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) for evaluation of pathologic nodal status.
Axillary nodal dissection(s) should yield a total of at least six nodes (including the axillary lymph nodes resected at the SLNB plus the lymph nodes collected at the axillary nodal dissection),
7. At least 4 weeks but no more than 12 weeks between definitive breast surgery (or the last surgery with curative intent if additional resection is required for breast cancer) and treatment initiation for cohort 1 and no more than 12 weeks for cohort 2,
8. Centrally assessed TILs score from surgical formalin-fixed paraffin embedded (FFPE) tumor sample, using an H\&E stained diagnostic digital slide, according to the most recent International TILs Working Group guidelines,
* Cohort 1 will include patients aged \> 40 years with 30% ≤ sTILs \< 50% and those aged
* 40 years with 30% ≤ sTILs \< 75%
* Cohort 2 will include patients aged \> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%
9. Women of childbearing potential have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication for cohort 1 and within 7 days of inclusion for cohort 2,
10. Women of childbearing potential must agree to use protocol-specified method(s) of contraception for 3 years after patient inclusion. Men subjects who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments.
Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year,
11. Patients affiliated to the social security system (or equivalent)- France only,
12. Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
13. Left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by echocardiogram or cardiac scintigraphy,
14. Demonstrate adequate organ function within 7 days of inclusion
* Absolute Neutrophil Count (ANC) ≥ 1,500 /µL
* Platelets ≥ 100,000 /µL
* Hemoglobin ≥ 9 g/dL
* Creatinine clearance ≥ 30 mL/min for subject with creatinine levels \> 1.5 x institutional upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Albumin ≥ 3.0 g/dL
* Lactate dehydrogenase (LDH) \< 2.5 X ULN
* International normalized ratio/partial thromboplastin time (INR/PTT) ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or PTT is within therapeutic range of intended use of anticoagulants)
* Thyroid stimulating hormone (TSH), free T4 (FT4), and free T3 (FT3) within normal ranges
* Cortisol at 8 AM within normal ranges
* Lipase and amylase \< 3 ULN
* Fasting plasma glucose ≤ 120 mg/dl or 6.7 mmol/L
* Troponin within normal range
16. Has cardiac dysfunction as defined by any of the following prior to inclusion:
* History of NCI-CTCAE v5.0 Grade \> 3 symptomatic congestive heart failure or New York Heart Association (NYHA) criteria Class II,
* Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease,
* Significant symptoms (≥ Grade 2) relating to left ventricular dysfunction or cardiac ischemia,
17. Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy or its analogs,
18. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment,
19. Concurrent active Hepatitis B virus (HBV; defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (HCV; defined as anti-HCV Ab positive and detectable HCV RNA) infection,
20. Severe infections within 4 weeks prior to initiation of study treatment, including, hospitalization for complications of infection, bacteremia, or severe pneumonia,
21. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; subjects receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible,
22. Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment,
23. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has a current pneumonitis/interstitial lung disease,
24. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.
Exclusion Criteria
1. History of invasive malignancy ≤ 3 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer,
2. Having received prior chemotherapy or targeted therapy within the past 12 months,
3. Has a prior history of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or radiotherapy to the ipsilateral breast; subjects who had their DCIS/LCIS treated only with surgery and/or contralateral DCIS treated with radiotherapy are allowed to enter the study,
4. Having received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137),
5. Treatment with systemic immunostimulatory agents (including, but not limited to, interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to inclusion,
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive medications (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] alpha agents) within 7 days prior to inclusion:
* Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
* The use of inhaled corticosteroids and mineralocorticoids is allowed,
7. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible if:
* Rash must covers \<10% of body surface area.
* Disease is well controlled at baseline and requires only low-potency topical Corticosteroids and no acute exacerbations requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or oral corticosteroids occurred within the previous 12 months,
8. Has a known history of Human Immunodeficiency Virus (HIV),
9. Prior allogeneic stem cell or solid organ transplant,
10. Has a known history of active Bacillus Tuberculosis,
11. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment are not eligible,
12. Pregnant women or breastfeeding or expecting to conceive within the projected duration of the study, from the inclusion visit until the end of the 3 years follow up. Men subjects who engage in heterosexual intercourse and refuse to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments,
13. Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial,
14. Person deprived of their liberty or under protective custody or guardianship,
15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
2. Having received prior chemotherapy or targeted therapy within the past 12 months,
3. Has a prior history of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or radiotherapy to the ipsilateral breast; subjects who had their DCIS/LCIS treated only with surgery and/or contralateral DCIS treated with radiotherapy are allowed to enter the study,
4. Having received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137),
5. Treatment with systemic immunostimulatory agents (including, but not limited to, interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to inclusion,
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive medications (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] alpha agents) within 7 days prior to inclusion:
* Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
* The use of inhaled corticosteroids and mineralocorticoids is allowed,
7. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible if:
* Rash must covers \<10% of body surface area.
* Disease is well controlled at baseline and requires only low-potency topical Corticosteroids and no acute exacerbations requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or oral corticosteroids occurred within the previous 12 months,
8. Has a known history of Human Immunodeficiency Virus (HIV),
9. Prior allogeneic stem cell or solid organ transplant,
10. Has a known history of active Bacillus Tuberculosis,
11. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment are not eligible,
12. Pregnant women or breastfeeding or expecting to conceive within the projected duration of the study, from the inclusion visit until the end of the 3 years follow up. Men subjects who engage in heterosexual intercourse and refuse to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments,
13. Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial,
14. Person deprived of their liberty or under protective custody or guardianship,
15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MSD France
INDUSTRY
Sponsor Role
collaborator
SOLTI Breast Cancer Research Group
OTHER
Sponsor Role
collaborator
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Sponsor Role
collaborator
Vall Hebron Insitut Recerca
NETWORK
Sponsor Role
collaborator
UNICANCER
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elie Rassy, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Villejuif, France
Barbara Pistilli, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Villejuif, France
Mafalda Oliveira, MD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL VALL D'HEBRÓN, Barcelona, Spain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens Picardie_Site Sud
Amiens, , France
Site Status
RECRUITING
Institut Sainte Catherine
Avignon, , France
Site Status
RECRUITING
Centre Hospitalier de la Côte Basque
Bayonne, , France
Site Status
RECRUITING
Institut Bergonié
Bordeaux, , France
Site Status
NOT_YET_RECRUITING
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Site Status
RECRUITING
Centre François Baclesse
Caen, , France
Site Status
RECRUITING
Pôle Santé Republique
Clermont-Ferrand, , France
Site Status
RECRUITING
Centre Jean Perrin
Clermont-Ferrand, , France
Site Status
RECRUITING
Centre Georges-François Leclerc
Dijon, , France
Site Status
NOT_YET_RECRUITING
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Levallois-Perret, , France
Site Status
NOT_YET_RECRUITING
CHU de Limoges
Limoges, , France
Site Status
RECRUITING
Centre Léon Bérard
Lyon, , France
Site Status
RECRUITING
Hopital Privé Jean Mermoz
Lyon, , France
Site Status
RECRUITING
Institut Paoli-Calmettes
Marseille, , France
Site Status
RECRUITING
Institut régional du Cancer de Montpellier
Montpellier, , France
Site Status
NOT_YET_RECRUITING
Hôpital privé du confluent
Nantes, , France
Site Status
RECRUITING
Centre Antoine Lacassagne
Nice, , France
Site Status
RECRUITING
CHU de Nîmes
Nîmes, , France
Site Status
RECRUITING
Centre Hospitalier de Pau
Pau, , France
Site Status
RECRUITING
Hôpital Privé des côtes d'Armor
Plérin, , France
Site Status
NOT_YET_RECRUITING
Hôpital NOVO
Pontoise, , France
Site Status
RECRUITING
Centre Hospitalier de Cornouaille
Quimper, , France
Site Status
RECRUITING
Clinique La Croix du Sud
Quint-Fonsegrives, , France
Site Status
WITHDRAWN
Institut Godinot
Reims, , France
Site Status
RECRUITING
Centre Eugène Marquis
Rennes, , France
Site Status
RECRUITING
CHU de Saint Etienne
Saint-Etienne, , France
Site Status
RECRUITING
Institut Claudius Regaud
Toulouse, , France
Site Status
RECRUITING
CHU Bretonneau
Tours, , France
Site Status
RECRUITING
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Site Status
RECRUITING
Gustave Roussy
Villejuif, , France
Site Status
RECRUITING
Hospital General Universitario Dr.Balmis
Alicante, , Spain
Site Status
NOT_YET_RECRUITING
Ico Badalona
Badalona, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Vall D'Hebrón
Barcelona, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Clinico San Cecilio
Granada, , Spain
Site Status
NOT_YET_RECRUITING
Ico Hospitalet
L'Hospitalet de Llobregat, , Spain
Site Status
RECRUITING
Complejo Asistencial Universitario de Leon
León, , Spain
Site Status
NOT_YET_RECRUITING
Hu Arnau de Vilanova Lleida
Lleida, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Ramon Y Cajal
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital 12 de Octubre
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Sant Joan de Reus
Reus, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Clínico Valencia
Valencia, , Spain
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
France
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Aurélie MOREIRA, MD
Role: primary
Julien GRENIER
Role: primary
Thomas GRELLETY, MD
Role: primary
Maxime BRUNET, MD
Role: primary
Nadine DOHOLLOU, MD
Role: primary
George EMILE, MD
Role: primary
Lionel Moreau, MD
Role: primary
Marie-Ange MOURET-REYNIER, MD
Role: primary
Isabelle DESMOULINS
Role: primary
Nathalie PEREZ-STAUB, MD
Role: primary
Elise DELUCHE, MD
Role: primary
Olivier TREDAN, MD
Role: primary
Olfa DERBEL, MD
Role: primary
Frédéric VIRET, MD
Role: primary
Véronique D'HONDT, MD
Role: primary
Dorothée CHOCTEAU-BOUJU, MD
Role: primary
Jean-Marc FERRERO
Role: primary
Frédéric FITENI, MD
Role: primary
Kévin BOURCIER, MD
Role: primary
Jérôme MARTIN-BABAU, MD
Role: primary
Rolande NGUEFACK
Role: primary
Mathilde BUREAU
Role: primary
Christelle JOUANNAUD, MD
Role: primary
Fanny LE DU, MD
Role: primary
Alicia QUILEZ-CUTILLAS, MD
Role: primary
Florence DALENC, MD
Role: primary
Marie-Agnès BY, MD
Role: primary
Anne KIEFFER, MD
Role: primary
Elie Rassy, MD
Role: primary
Margeli VILA
Role: primary
Mafalda OLIVEIRA, MD
Role: primary
Pilar SANCHEZ HENAREJOS, MD
Role: primary
Maria Isabel BLANCAS, MD
Role: primary
Sonia PERNAS, MD
Role: primary
Maria MARTINEZ GARCIA, MD
Role: primary
Serafin MORALES
Role: primary
Elena LÓPEZ FLORES
Role: primary
Manuel ALVA BIANCHI, MD
Role: primary
Antonia PERELLÓ, MD
Role: primary
Alba COCHS
Role: primary
Monica CEJUELA
Role: primary
Juan Miguel CEJALVO
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-504620-26-00
Identifier Type: OTHER
Identifier Source: secondary_id
UC-BCG-2213
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab
NCT06371807
NOT_YET_RECRUITING
PHASE2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT06797635
RECRUITING
PHASE2
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
NCT02819518
COMPLETED
PHASE3
A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
NCT05675579
ACTIVE_NOT_RECRUITING
PHASE2
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)
NCT02622074
COMPLETED
PHASE1
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
NCT03036488
COMPLETED
PHASE3
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
NCT04373031
ACTIVE_NOT_RECRUITING
PHASE2
A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
NCT06841354
RECRUITING
PHASE3
SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
NCT06627712
RECRUITING
PHASE3
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
NCT06081244
RECRUITING
PHASE3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
NCT06393374
RECRUITING
PHASE3
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
NCT03197935
COMPLETED
PHASE3
Neoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer
NCT06604858
RECRUITING
PHASE2
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
NCT05812807
RECRUITING
PHASE3
Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer
NCT02318901
TERMINATED
PHASE1/PHASE2
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
NCT07011823
NOT_YET_RECRUITING
PHASE2
The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel
NCT07187674
NOT_YET_RECRUITING
NA
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176
RECRUITING
PHASE3
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
NCT03125902
COMPLETED
PHASE3
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
NCT06705127
RECRUITING
PHASE2
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
NCT05382286
ACTIVE_NOT_RECRUITING
PHASE3
A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)
NCT07054242
NOT_YET_RECRUITING
PHASE2
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
NCT02977468
RECRUITING
PHASE1