Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
- Conditions
- Breast Cancer
- Interventions
- Drug: Placebo (P)Drug: Endocrine therapyRadiation: Radiation therapyProcedure: Surgery
- Registration Number
- NCT03725059
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
- Detailed Description
Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer. After surgery, participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1240
- Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
- Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
- Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.
Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were obtained greater than 60 days prior to the date that the documented informed consent was obtained.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment.
- Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
- Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo.
- Has adequate organ function.
- Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
- Has breast cancer with lobular histology.
- Has bilateral invasive breast cancer.
- Has metastatic (Stage IV) breast cancer.
- Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
- Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
- Has ER-, progesterone receptor positive breast cancer.
- Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment.
- Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- 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) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Has a known history of active tuberculosis (Bacillus tuberculosis).
- Has an active infection requiring systemic therapy.
- Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
- Has other significant cardiac disease, such as: 1) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months. or 2) Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B or known active hepatitis C virus infection.
- Has received prior treatment for breast cancer.
- Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137).
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
- Has severe hypersensitivity (≥Grade 3) to any of the components or excipients used in the study treatments.
- Is/was enrolled in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks (12 months for an investigational agent or device with anticancer or antiproliferative properties) prior to the first dose of study treatment.
- Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab+Chemotherapy (KX/KA[E]C) Doxorubicin (A) In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Endocrine therapy In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Radiation therapy In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Surgery In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Placebo (P) In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Paclitaxel (X) In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Doxorubicin (A) In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Epirubicin (E) In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Radiation therapy In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Surgery In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Paclitaxel (X) In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Pembrolizumab (K) In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Epirubicin (E) In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Pembrolizumab+Chemotherapy (KX/KA[E]C) Cyclophosphamide (C) In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long. Placebo+Chemotherapy (PX/PA[E]C) Cyclophosphamide (C) In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\^2 or 100 mg/m\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 Up to approximately 7 months (Time of surgery) The pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pathological Complete Response (pCR) using the definition of (ypT0/Tis ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
Event-Free Survival (EFS) Up to approximately 12 years EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator will be presented.
- Secondary Outcome Measures
Name Time Method pCR Rate Using the Definition of ypT0ypN0 Up to approximately 7 months (Time of surgery) pCR rate (ypT0ypN0) is defined as the percentage of participants without residual invasive or in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of (ypT0ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
pCR Rate Using the Definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in Participants With a Combined Positive Score [CPS] ≥1 Up to approximately 7 months (Time of surgery) pCR rates were calculated using the definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the three definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in participants with a CPS ≥1 (with a positive Programmed Cell Death-Ligand 1 \[PD-L1\] tumor status) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
OS in Participants With a CPS ≥1 Up to approximately 12 years OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies for participants with a CPS ≥1 will be presented.
Number of Participants Experiencing an Adverse Event (AE) Up to approximately 15 months An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Number of Participants Experiencing a Serious Adverse Event (SAE) Up to approximately 17 months An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience an SAE while receiving pembrolizumab or placebo (including 3 months of safety follow up) will be presented.
Overall Survival (OS) Up to approximately 12 years OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies will be presented.
Number of Participants Experiencing an Immune-related AE (irAE) Up to approximately 15 months Some AEs that may occur in this study that are known to be related to pembrolizumab immunotherapy treatment and may include: pneumonitis, diarrhea/colitis, aspartate aminotransferase/alanine aminotransferase (AST/ALT) elevation or increased bilirubin, Type 1 diabetes mellitus or hyperglycemia, hypophysitis, hyperthyroidism, hypothyroidism, nephritis and renal dysfunction, and myocarditis. The number of participants who experience an irAE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.
Number of Participants who Discontinued Study Treatment Due to an AE Up to approximately 14 months An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment (pembrolizumab or placebo) due to an AE will be presented.
pCR Rate Using the Definition of ypT0/Tis Up to approximately 7 months (Time of surgery) pCR rate (ypT0/Tis) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen (independent of lymph node involvement) after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of ypT0/Tis will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.
EFS in Participants With a CPS ≥1 Up to approximately 12 years EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator for participants with a CPS ≥1 will be presented.
Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days. The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses for each of 28 items are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome, and responses for each of 2 items (overall health and overall quality of life) are given on a 7-point scale (1=Very poor to 7=Excellent), with a higher score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC-QLQ-C30 scores for participants will be presented.
Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days. The EORTC QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life in women with breast cancer. Responses for each item are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC QLQ-BR23 score for participants will be presented.
Trial Locations
- Locations (244)
Geisinger Medical Center ( Site 0052)
🇺🇸Danville, Pennsylvania, United States
Westmead Hospital ( Site 2101)
🇦🇺Sydney, New South Wales, Australia
Massachusetts General Hospital ( Site 0024)
🇺🇸Boston, Massachusetts, United States
UZ Leuven ( Site 0702)
🇧🇪Leuven, Vlaams-Brabant, Belgium
AZ Maria Middelares Gent ( Site 0700)
🇧🇪Gent, Oost-Vlaanderen, Belgium
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
🇧🇷Ijui, Rio Grande Do Sul, Brazil
CHU UCL Namur Site de Godinne ( Site 0706)
🇧🇪Yvoir, Namur, Belgium
Associacao Hospitalar Moinhos de Vento ( Site 0201)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
St. Vincent Frontier Cancer Center ( Site 0033)
🇺🇸Billings, Montana, United States
Clínica Vida Fundación - Sede Poblado ( Site 0405)
🇨🇴Medellin, Antioquia, Colombia
Rodrigo Botero SAS ( Site 0407)
🇨🇴Medellin, Antioquia, Colombia
Hospital Metropolitano - Sede Lindora ( Site 4203)
🇨🇷Santa Ana, San Jose, Costa Rica
Linkou Chang Gung Memorial Hospital ( Site 2402)
🇨🇳Taoyuan, Taiwan
Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Clinica de la Costa Ltda. ( Site 0400)
🇨🇴Barranquilla, Atlantico, Colombia
Fundacion Universitaria Sanitas ( Site 0403)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Institut Claudius Regaud IUCT Oncopole ( Site 0903)
🇫🇷Toulouse, Haute-Garonne, France
Institut Curie - Centre Rene Huguenin ( Site 0917)
🇫🇷Saint-Cloud, Hauts-de-Seine, France
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)
🇭🇺Pecs, Baranya, Hungary
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)
🇵🇹Porto, Portugal
Centre Francois Baclesse ( Site 0927)
🇫🇷Caen, Calvados, France
CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)
🇫🇷Metz, Moselle, France
Bialostockie Centrum Onkologii ( Site 1819)
🇵🇱Bialystok, Podlaskie, Poland
Fundacao Champalimaud ( Site 2500)
🇵🇹Lisboa, Aveiro, Portugal
Hospital Geral de Santo Antonio ( Site 2503)
🇵🇹Porto, Portugal
Oncomedica S.A. ( Site 0401)
🇨🇴Monteria, Cordoba, Colombia
Khmelnitskiy Regional Onkology Dispensary ( Site 2704)
🇺🇦Khmelnitskiy, Khmelnytska Oblast, Ukraine
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)
🇨🇳Taipei, Taiwan
St. James s Hospital ( Site 1553)
🇮🇪Dublin, Ireland
Medical center of the Limited Liability Company Yulis ( Site 2720)
🇺🇦Zaporizhzhia, Zaporizka Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
MI Odesa Regional Clinical Hospital ( Site 2701)
🇺🇦Odesa, Odeska Oblast, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)
🇺🇦Kryviy Rih, Dnipropetrovska Oblast, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 2719)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2714)
🇺🇦Odesa, Odeska Oblast, Ukraine
Anhui Provincial Hospital ( Site 3224)
🇨🇳Heifei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)
🇨🇳Beijing, Beijing, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital ( Site 3212)
🇨🇳Zhengzhou, Henan, China
Fudan University Shanghai Cancer Center ( Site 3205)
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)
🇨🇳XI An, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3209)
🇨🇳Tianjin, Tianjin, China
Texas Oncology-Austin Central ( Site 8004)
🇺🇸Austin, Texas, United States
Texas Oncology-Tyler ( Site 8006)
🇺🇸Tyler, Texas, United States
Southeastern Regional Medical Center, Inc. ( Site 0075)
🇺🇸Newnan, Georgia, United States
MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)
🇺🇸Newton, Massachusetts, United States
El Camino Hospital Cancer Center ( Site 0004)
🇺🇸Mountain View, California, United States
Arizona Oncology Associates PC- HOPE ( Site 8008)
🇺🇸Tucson, Arizona, United States
Baptist MD Anderson Cancer Center ( Site 0014)
🇺🇸Jacksonville, Florida, United States
Orchard Healthcare Research Inc. ( Site 0020)
🇺🇸Skokie, Illinois, United States
The University of Chicago Medical Center ( Site 0080)
🇺🇸Chicago, Illinois, United States
Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)
🇨🇳Shanghai, Anhui, China
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)
🇺🇸Dallas, Texas, United States
MercyOne Waterloo Cancer Center ( Site 0016)
🇺🇸Waterloo, Iowa, United States
Chris OBrien Lifehouse ( Site 2107)
🇦🇺Camperdown, New South Wales, Australia
Cross Cancer Institute ( Site 0115)
🇨🇦Edmonton, Alberta, Canada
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)
🇧🇷Sao Paulo, Brazil
Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)
🇺🇸Dallas, Texas, United States
Texas Oncology-Memorial City ( Site 8012)
🇺🇸Houston, Texas, United States
Goshen Center for Cancer Care ( Site 0021)
🇺🇸Goshen, Indiana, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)
🇺🇸Spokane, Washington, United States
Centre Oscar Lambret ( Site 0911)
🇫🇷Lille, Nord-Pas-de-Calais, France
BC Cancer-Vancouver Center ( Site 0116)
🇨🇦Vancouver, British Columbia, Canada
Centre de Cancerologie du Grand Montpellier ( Site 0925)
🇫🇷Montpellier, Herault, France
University of Texas-MD Anderson Cancer Center ( Site 0083)
🇺🇸Houston, Texas, United States
Clinique Victor Hugo ( Site 0906)
🇫🇷Le Mans, Sarthe, France
Gynaekologisch-onkologische Praxis Hannover ( Site 1013)
🇩🇪Hannover, Niedersachsen, Germany
Centre Jean Perrin ( Site 0909)
🇫🇷Clermont Ferrand Cedex, Puy-de-Dome, France
Institut Gustave Roussy ( Site 0926)
🇫🇷Villejuif, Val-de-Marne, France
Sana Klinikum Offenbach GmbH ( Site 1002)
🇩🇪Offenbach, Hessen, Germany
Hopital Tenon ( Site 0914)
🇫🇷Paris, France
Saitama Cancer Center ( Site 2612)
🇯🇵Kitaadachi-gun, Saitama, Japan
Hopital Saint-Louis ( Site 0908)
🇫🇷Paris, France
Szent Margit Korhaz ( Site 2901)
🇭🇺Budapest, Hungary
Gynaekologisches Zentrum ( Site 1003)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitaetsklinikum Erlangen ( Site 1001)
🇩🇪Erlangen, Bayern, Germany
Frauenklinik St. Louise ( Site 1014)
🇩🇪Paderborn, Nordrhein-Westfalen, Germany
Bacs-Kiskun Megyei Korhaz ( Site 2913)
🇭🇺Kecskemet, Bacs-Kiskun, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)
🇭🇺Kaposvar, Hungary
MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)
🇩🇪Nordhausen, Thuringen, Germany
Orszagos Onkologiai Intezet ( Site 2908)
🇭🇺Budapest, Hungary
Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)
🇩🇪Saarbruecken, Saarland, Germany
Uzsoki Utcai Korhaz ( Site 2902)
🇭🇺Budapest, Hungary
Bon Secours Hospital ( Site 1554)
🇮🇪Cork, Ireland
Universitaetsklinikum Carl Gustav Carus ( Site 1008)
🇩🇪Dresden, Sachsen, Germany
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)
🇭🇺Miskolc, Borsod-Abauj-Zemplen, Hungary
HaEmek Medical Center ( Site 1712)
🇮🇱Afula, Israel
Instytut Centrum Zdrowia Matki Polki ( Site 1821)
🇵🇱Lodz, Lodzkie, Poland
Kitasato University Hospital ( Site 2616)
🇯🇵Sagamihara, Kanagawa, Japan
Hyogo College of Medicine Hospital ( Site 2600)
🇯🇵Nishinomiya, Hyogo, Japan
Assuta Ashdod Public ( Site 1704)
🇮🇱Ashdod, Israel
Rambam Health Care Campus-Oncology Division ( Site 1705)
🇮🇱Haifa, Israel
Showa University Hospital ( Site 2615)
🇯🇵Tokyo, Japan
Shaare Zedek Medical Center ( Site 1708)
🇮🇱Jerusalem, Israel
Meir Medical Center ( Site 1710)
🇮🇱Kfar-Saba, Israel
Fukushima Medical University Hospital ( Site 2610)
🇯🇵Fukushima, Japan
Capital & Coast District Health Board - Wellington Hospital ( Site 2301)
🇳🇿Wellington, New Zealand
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)
🇵🇱Ostroleka, Mazowieckie, Poland
Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)
🇯🇵Sunto-gun, Shizuoka, Japan
Mazowiecki Szpital Onkologiczny ( Site 1803)
🇵🇱Wieliszew, Mazowieckie, Poland
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)
🇮🇱Jerusalem, Israel
Holy Family Hospital ( Site 1711)
🇮🇱Nazareth, Israel
Kaplan Medical Center ( Site 1703)
🇮🇱Rehovot, Israel
Assuta Medical Center ( Site 1709)
🇮🇱Tel Aviv, Israel
National Cancer Center Hospital East ( Site 2613)
🇯🇵Kashiwa, Chiba, Japan
Chiba Cancer Center ( Site 2605)
🇯🇵Chiba, Japan
National Cancer Center ( Site 2204)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 2202)
🇰🇷Songpagu, Seoul, Korea, Republic of
Sourasky Medical Center ( Site 1706)
🇮🇱Tel Aviv, Israel
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Samsung Medical Center ( Site 2203)
🇰🇷Seoul, Korea, Republic of
CHLN Hospital Santa Maria ( Site 2501)
🇵🇹Lisboa, Portugal
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
Arkhangelsk Clinical Oncological Dispensary ( Site 1901)
🇷🇺Arkhangelsk, Arkhangel Skaya Oblast, Russian Federation
Hospital Teresa Herrera - Chuac ( Site 1358)
🇪🇸A Coruna, La Coruna, Spain
Hospital Quiron de Madrid ( Site 1351)
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)
🇵🇱Gdansk, Pomorskie, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1818)
🇵🇱Gdynia, Pomorskie, Poland
N.N. Blokhin NMRCO ( Site 1908)
🇷🇺Moscow, Moskva, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)
🇷🇺Ufa, Baskortostan, Respublika, Russian Federation
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)
🇵🇱Bytom, Slaskie, Poland
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)
🇵🇱Gliwice, Slaskie, Poland
UPR Comprehensive Cancer Center ( Site 6200)
🇵🇷San Juan, Puerto Rico
China Medical University Hospital ( Site 2401)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital ( Site 2400)
🇨🇳Tainan, Taiwan
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)
🇪🇸Barcelona, Spain
Complejo Hospitalario de Jaen ( Site 1364)
🇪🇸Jaen, Spain
Hospital Ruber Internacional ( Site 1370)
🇪🇸Madrid, Spain
Hospital Clinico San Carlos ( Site 1354)
🇪🇸Madrid, Spain
National Taiwan University Hospital ( Site 2404)
🇨🇳Taipei, Taiwan
Hospital Clinic I Provincial de Barcelona ( Site 1353)
🇪🇸Barcelona, Spain
Hospital Clinico Universitario de Valencia ( Site 1355)
🇪🇸Valencia, Valenciana, Comunitat, Spain
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
🇺🇦Antonivka Village, Khersonska Oblast, Ukraine
Colchester General Hospital ( Site 1508)
🇬🇧Colchester, Essex, United Kingdom
Barts Health NHS Trust ( Site 1500)
🇬🇧London, London, City Of, United Kingdom
University Hospitals Bristol NHS Foundation Trust ( Site 1503)
🇬🇧Bristol, Bristol, City Of, United Kingdom
Kyiv City Clinical Oncology Centre ( Site 2716)
🇺🇦Kyiv, Ukraine
Guy's Hospital ( Site 1501)
🇬🇧London, London, City Of, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1505)
🇬🇧London, London, City Of, United Kingdom
Toranomon Hospital ( Site 2608)
🇯🇵Tokyo, Japan
Saitama Medical University International Medical Center ( Site 2606)
🇯🇵Hidaka, Saitama, Japan
Kumamoto University Hospital ( Site 2602)
🇯🇵Kumamoto, Japan
The Cancer Institute Hospital of JFCR ( Site 2604)
🇯🇵Tokyo, Japan
Hospital Vall D Hebron ( Site 1357)
🇪🇸Barcelona, Spain
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)
🇩🇪Muenchen, Bayern, Germany
Hospital Universitario 12 de Octubre ( Site 1356)
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio ( Site 1360)
🇪🇸Sevilla, Spain
Hospital General Arnau de Vilanova de Valencia ( Site 1369)
🇪🇸Valencia, Spain
Ryazan Regional Clinical Oncology Dispensary ( Site 1910)
🇷🇺Ryazan, Ryazanskaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Tomsk Scientific Research Institute of Oncology ( Site 1905)
🇷🇺Tomsk, Tomskaya Oblast, Russian Federation
Rabin Medical Center ( Site 1702)
🇮🇱Petah Tikva, Israel
Chaim Sheba Medical Center. ( Site 1707)
🇮🇱Ramat Gan, Israel
Texas Oncology- Plano East ( Site 8010)
🇺🇸Plano, Texas, United States
University of Colorado Cancer Center ( Site 0008)
🇺🇸Aurora, Colorado, United States
Maryland Oncology Hematology, P.A. ( Site 8007)
🇺🇸Bethesda, Maryland, United States
Mayo Clinic and Medical School (Rochester) ( Site 0029)
🇺🇸Rochester, Minnesota, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)
🇺🇸Omaha, Nebraska, United States
OHSU Knight Cancer Institute ( Site 0051)
🇺🇸Portland, Oregon, United States
Virginia Oncology Associates ( Site 8001)
🇺🇸Norfolk, Virginia, United States
Canterbury Regional Cancer & Blood Services ( Site 2303)
🇳🇿Christchurch, Canterbury, New Zealand
Southern Cancer Center, PC ( Site 8003)
🇺🇸Daphne, Alabama, United States
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)
🇺🇸Los Angeles, California, United States
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)
🇺🇸Goodyear, Arizona, United States
Stanford Cancer Center ( Site 0072)
🇺🇸Palo Alto, California, United States
Midwestern Regional Medical Center, Inc. ( Site 0077)
🇺🇸Zion, Illinois, United States
Henry Ford Health System ( Site 0028)
🇺🇸Detroit, Michigan, United States
MGH - North Shore Cancer Center ( Site 0081)
🇺🇸Danvers, Massachusetts, United States
Weill Cornell Medical College ( Site 0043)
🇺🇸New York, New York, United States
Holy Name Medical Center ( Site 0041)
🇺🇸Teaneck, New Jersey, United States
CTCA Southwestern ( Site 0074)
🇺🇸Tulsa, Oklahoma, United States
Northwest Cancer Specialists, P.C. ( Site 8000)
🇺🇸Tigard, Oregon, United States
Fox Chase Cancer Center ( Site 0078)
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina ( Site 0053)
🇺🇸Charleston, South Carolina, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)
🇺🇸Nashville, Tennessee, United States
Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)
🇺🇸Midlothian, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0070)
🇺🇸Kennewick, Washington, United States
Royal North Shore Hospital ( Site 2100)
🇦🇺Sydney, New South Wales, Australia
Frankston Hospital ( Site 2103)
🇦🇺Frankston, Victoria, Australia
Mater Misericordiae Ltd ( Site 2106)
🇦🇺South Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre ( Site 2102)
🇦🇺Melbourne, Victoria, Australia
Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)
🇧🇪Hasselt, Limburg, Belgium
CHC MontLegia ( Site 0707)
🇧🇪Liège, Liege, Belgium
Cliniques Universitaires Saint-Luc ( Site 0701)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
AZ Groeninge ( Site 0705)
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)
🇧🇷Goiania, Goias, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0208)
🇧🇷Florianopolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)
🇧🇷Itajai, Santa Catarina, Brazil
Instituto Nacional de Cancer - INCA HC III ( Site 0200)
🇧🇷Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)
🇧🇷Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)
🇧🇷São Paulo, Sao Paulo, Brazil
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)
🇨🇦Quebec, Canada
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)
🇨🇦Trois-Rivières, Quebec, Canada
Princess Margaret Cancer Centre ( Site 0112)
🇨🇦Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0108)
🇨🇦Greenfield Park, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital ( Site 0103)
🇨🇦Montreal, Quebec, Canada
Harbin Medical University Cancer Hospital ( Site 3200)
🇨🇳Harbin, Heilongjiang, China
Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)
🇨🇳Fuzhou Fujian, Fujian, China
The First Affiliated Hospital of Zhejiang University ( Site 3203)
🇨🇳Hangzhou, Jiangsu, China
Hubei Cancer Hospital ( Site 3211)
🇨🇳Wuhan, Hubei, China
Fourth Hospital Of Hebei Medical University ( Site 3216)
🇨🇳Shijia Zhuang, Hebei, China
Hunan Cancer Hospital ( Site 3214)
🇨🇳Changsha, Hunan, China
The First Hospital of Jilin University ( Site 3201)
🇨🇳Changchun, Jilin, China
Zhejiang Cancer Hospital.... ( Site 3210)
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital ( Site 3225)
🇨🇳Hangzhou, Zhejiang, China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)
🇨🇳Urumqi, Xinjiang, China
Centro de Investigacion Clinica del Country ( Site 0402)
🇨🇴Bogota, Distrito Capital De Bogota, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0406)
🇨🇴Cali, Valle Del Cauca, Colombia
Institut Sainte Catherine ( Site 0916)
🇫🇷Avignon, Provence-Alpes-Cote-d Azur, France
Centre Georges Francois Leclerc ( Site 0920)
🇫🇷Dijon, Cote-d Or, France
Institut Curie ( Site 0900)
🇫🇷Paris, France
Medizinische Management GmbH ( Site 1012)
🇩🇪Friedrichshafen, Baden-Wurttemberg, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)
🇩🇪Wiesbaden, Hessen, Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Debreceni Egyetem Klinikai Kozpont ( Site 2907)
🇭🇺Debrecen, Hungary
Soroka Medical Center ( Site 1701)
🇮🇱Beer Sheva, Israel
National Hospital Organization Hokkaido Cancer Center ( Site 2607)
🇯🇵Sapporo, Hokkaido, Japan
Aichi Cancer Center Hospital ( Site 2601)
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26
🇯🇵Osaka, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2603)
🇯🇵Hiroshima, Japan
Tauranga Hospital ( Site 2302)
🇳🇿Tauranga, Bay Of Plenty, New Zealand
Severance Hospital Yonsei University Health System ( Site 2201)
🇰🇷Seoul, Korea, Republic of
Dolnoslaskie Centrum Onkologii. ( Site 1820)
🇵🇱Wrocław, Dolnoslaskie, Poland
Seoul National University Hospital ( Site 2200)
🇰🇷Seoul, Korea, Republic of
Medical Rehabilitation Center ( Site 1912)
🇷🇺Moscow, Moskva, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Central Clinical Hospital with outpatient Clinic ( Site 1907)
🇷🇺Moscow, Moskva, Russian Federation
Railway Hospital of OJSC ( Site 1913)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Hospital General Universitario Gregorio Maranon ( Site 1367)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)
🇬🇧Solihull, United Kingdom
Royal Cornwall Hospital ( Site 1502)
🇬🇧Truro, United Kingdom
UC Davis Comprehensive Cancer Center ( Site 0073)
🇺🇸Sacramento, California, United States
James Graham Brown Cancer Center ( Site 0022)
🇺🇸Louisville, Kentucky, United States
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)
🇵🇱Bielsko-Biala, Slaskie, Poland
Institut Jules Bordet ( Site 0710)
🇧🇪Anderlecht, Bruxelles-Capitale, Region De, Belgium
Imelda Ziekenhuis Bonheiden ( Site 0703)
🇧🇪Bonheiden, Antwerpen, Belgium
UZ Antwerpen - Medical Oncology ( Site 0709)
🇧🇪Edegem, Antwerpen, Belgium
MI Precarpathian Clinical Oncology Center ( Site 2707)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Nottingham University Hospitals NHS Trust ( Site 1504)
🇬🇧Nottingham, England, United Kingdom