Study Summary
This trial will assess if pembrolizumab, when combined with chemotherapy, is more effective in treating hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer than chemotherapy alone. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
4 Primary · 30 Secondary · Reporting Duration: Up to approximately 75 months
Month 75
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Malignant Neoplasms
Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Month 33
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Month 75
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
OS in Participants With CPS ≥1
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥10
Percentage of Participants who Discontinue Study Drug due to an AE
Percentage of Participants who Experience an Adverse Event (AE)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥1
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥10
Diarrhea
Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1
Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Side Effects for
Pembrolizumab
17%Decreased appetite
16%Fatigue
16%Dyspnoea
16%Cough
15%Anaemia
12%Constipation
12%Hypothyroidism
11%Nausea
11%Diarrhoea
11%Rash
10%Pruritus
10%Weight decreased
10%Asthenia
10%Pyrexia
10%Alanine aminotransferase increased
10%Back pain
9%Arthralgia
9%Aspartate aminotransferase increased
8%Chest pain
8%Vomiting
7%Pneumonia
7%Headache
7%Haemoptysis
6%Hyperthyroidism
6%Upper respiratory tract infection
6%Blood alkaline phosphatase increased
6%Musculoskeletal pain
6%Hypertension
5%Oedema peripheral
5%Pain in extremity
5%Myalgia
5%Insomnia
4%Pneumonitis
4%Dizziness
3%Stomatitis
3%Malaise
2%Death
2%Pleural effusion
2%Pulmonary embolism
2%Leukopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%White blood cell count decreased
1%Pericardial effusion
1%Colitis
1%Autoimmune hepatitis
1%Bronchitis
1%Sepsis
1%Interstitial lung disease
1%Pulmonary haemorrhage
1%Respiratory failure
1%Neutropenia
1%Thrombocytopenia
1%Neuropathy peripheral
1%Peripheral sensory neuropathy
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2 Treatment Groups
Placebo + Chemotherapy
1 of 2
Pembrolizumab + Chemotherapy
1 of 2
Active Control
Experimental Treatment
800 Total Participants · 2 Treatment Groups
Primary Treatment: pembrolizumab · No Placebo Group · Phase 3
Pembrolizumab + ChemotherapyExperimental Group · 5 Interventions: paclitaxel, nab-paclitaxel, pembrolizumab, liposomal doxorubicin, capecitabine · Intervention Types: Drug, Drug, Biological, Drug, Drug
Placebo + ChemotherapyActiveComparator Group · 6 Interventions: paclitaxel, nab-paclitaxel, liposomal doxorubicin, dextrose, normal saline, capecitabine · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Paclitaxel
FDA approved
Pembrolizumab
FDA approved
Doxorubicin
FDA approved
Capecitabine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 75 months
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,595 Total Patients Enrolled
18 Trials studying Breast Cancer
5,560 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,737 Previous Clinical Trials
4,973,030 Total Patients Enrolled
56 Trials studying Breast Cancer
7,384 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,670 Previous Clinical Trials
7,958,412 Total Patients Enrolled
7 Trials studying Breast Cancer
1,733 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Criterion: The most important factors required to participate in the study.
Frequently Asked Questions
What are the standard indication for pembrolizumab?
"Pembrolizumab can be used to treat three different types of cancer: unresectable melanoma, microsatellite instability high, and neuroblastoma (nb)." - Anonymous Online Contributor
Unverified Answer
Is this a new way to test treatments?
"Alfacell conducted the first pembrolizumab clinical trial in 1997 with 300 patients. After the success of that Phase 3 study, the drug received approval and today there are 2361 ongoing trials in 85 countries around the world." - Anonymous Online Contributor
Unverified Answer
Could you list other pembrolizumab studies that have been completed in the past?
"There are a total of 2361 clinical trials investigating pembrolizumab. 531 of those studies are currently in Phase 3. The vast majority of pembrolizumab trials are being conducted in Guangzhou, Guangdong. However, there are 97433 total locations running pembrolizumab trials." - Anonymous Online Contributor
Unverified Answer
Are there serious dangers associated with pembrolizumab?
"Pembrolizumab's Phase 3 status and the presence of efficacy data means that it receives a safety score of 3." - Anonymous Online Contributor
Unverified Answer
In which continent is this trial most popular?
"This clinical trial is currently underway at 42 different medical facilities. Some notable locations include Sanford Fargo Medical Center ( Site 0040) in Fargo, University of Alabama at Birmingham-Medicine ( Site 0065) in Birmingham, and University Cancer & Blood Center, LLC ( Site 0032) in Athens." - Anonymous Online Contributor
Unverified Answer