Evidence Level:Sensitive: B - Late Trials
Title:
Phase 3 study of neoadjuvant pembrolizumab or placebo plus chemotherapy, followed by adjuvant pembrolizumab or placebo plus endocrine therapy for early-stage high-risk ER+/HER2− breast cancer: KEYNOTE-756
Excerpt:In the ITT population, pembrolizumab + chemotherapy showed a statistically significant improvement in pCR...The addition of pembrolizumab to chemotherapy significantly increased the pCR rate and shifted RCB to lower residual disease categories in patients with early-stage high-risk ER+/HER2−breast cancer….
Evidence Level:Sensitive: B - Late Trials
Title:
Merck Announces Phase 3 KEYNOTE-756 Trial Met Primary Endpoint of Pathological Complete Response (pCR) Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer
Excerpt:Merck...announced that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
Excerpt:...- High-risk, ER-positive and HER2-negative breast cancer patients....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients
Excerpt:...- Tumor is estrogen receptor positive (ER+) and/or (PR+), HER-2 negative (HER2-)....
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Pembrolizumab and Exemestane/ Leuprolide in Premenopausal HR+/ HER2- Locally Advanced or Metastatic Breast Cancer
Excerpt:...Have histologically confirmed ER positive (defined as ≥1%) and/ or PR positive (defined as ≥1%) breast cancer....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Evaluation of Pembrolizumab in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide
Excerpt:...Patients with ER-positive tumors must have received at least one prior endocrine therapy, either in the adjuvant setting or in the metastatic setting....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.
Excerpt:...ER/PR negative or ER positive....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer
Excerpt:...Have pathological diagnosis of breast cancer, ER positive (%ER+ cells≥1%, Allred score ≥3), Her2 negative subtype, locally advanced (stage III non-operable), or metastatic (stage IV) disease....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer
Excerpt:...hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol; however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy; elective surgery or surgery that is...