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Antimetabolites

Pembrolizumab + Chemotherapy for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
Must not have
Has received prior therapy with certain immunotherapy agents
Has a known germline BRCA mutation and has not received previous treatment with PARP inhibition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 75 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Who is the study for?
This trial is for adults with HR+/HER2- breast cancer that's locally recurrent and inoperable or has spread (metastatic), who haven't had chemotherapy for this condition before, but have progressed after endocrine therapy. They should be candidates for chemotherapy, have a certain level of PD-L1 protein on their tumor cells, good organ function, measurable disease per RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.
What is being tested?
The study tests if pembrolizumab combined with the investigator's choice of chemotherapy improves survival without cancer progression compared to placebo plus chemotherapy in patients whose tumors express PD-L1. The effectiveness will be measured by how long patients live without their disease getting worse (PFS) and overall survival (OS).
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug entering the body, fatigue, skin issues like rash or itching, digestive problems like diarrhea or nausea, liver function changes and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is HR+/HER2-, not treated with chemotherapy for advanced stages.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has worsened after hormone therapy, and I am now eligible for chemotherapy.
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My cancer has worsened despite the last hormone therapy I received.
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I have provided a recent biopsy from a cancer area not treated with radiation.
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My breast cancer is HR+ and HER2- with a PD-L1 CPS of 1 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with immunotherapy before.
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I have a BRCA mutation and haven't been treated with PARP inhibitors.
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I have an active case of tuberculosis.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
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I have received an organ or tissue transplant from another person.
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I am currently being treated for an infection.
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My cancer is only in my skin.
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I have had chemotherapy for breast cancer that has returned or spread and cannot be removed by surgery.
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I am severely allergic to pembrolizumab or its ingredients, or to the chemotherapy I plan to receive.
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I have active cancer spread to my brain or spinal cord.
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My breast cancer can be treated with the goal of curing it.
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I haven't had radiotherapy or needed steroids for side effects in the last 2 weeks.
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I have a serious heart condition.
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My cancer has spread to other organs and is causing symptoms.
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I haven't had cancer treatment with experimental drugs in the last 4 weeks.
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I have or had lung inflammation that needed steroids.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been diagnosed with cancer in the lining of my brain and spinal cord.
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I have been diagnosed with HIV.
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I have tested positive for COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 75 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 75 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS in Participants With CPS ≥1
Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥10
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
+1 more
Secondary study objectives
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
+27 more

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Bronchitis
9%
Haemoptysis
9%
Constipation
9%
Aspartate aminotransferase increased
9%
Diarrhoea
9%
Decreased appetite
9%
Arthralgia
9%
Nasopharyngitis
9%
Alanine aminotransferase increased
9%
Hypothyroidism
6%
Headache
6%
Anaemia
6%
Cough
6%
Pruritus
6%
Asthenia
6%
Blood alkaline phosphatase increased
6%
Pneumonia
3%
Back pain
3%
Subdural haemorrhage
3%
Dyspnoea
3%
Upper respiratory tract infection
3%
Leukopenia
3%
Oedema peripheral
3%
Nausea
3%
Pyrexia
3%
Lymph gland infection
3%
Hyperglycaemia
3%
Tumour associated fever
3%
Malaise
3%
Rash
3%
Myalgia
3%
Upper gastrointestinal haemorrhage
3%
Chest pain
3%
White blood cell count decreased
3%
Hypertension
3%
Haematemesis
3%
Pneumonia bacterial
3%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + ChemotherapyExperimental Treatment5 Interventions
Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.
Group II: Placebo + ChemotherapyActive Control6 Interventions
Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 PO BID on Days 1-14 Q3W for up to 35 administrations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~6070
paclitaxel
1996
Completed Phase 3
~4310
nab-paclitaxel
2008
Completed Phase 4
~1420
liposomal doxorubicin
2009
Completed Phase 3
~600
capecitabine
2002
Completed Phase 3
~2360

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,558 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,981 Previous Clinical Trials
5,177,209 Total Patients Enrolled
60 Trials studying Breast Cancer
7,420 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,866 Previous Clinical Trials
8,081,782 Total Patients Enrolled
8 Trials studying Breast Cancer
5,963 Patients Enrolled for Breast Cancer

Media Library

Capecitabine (Antimetabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04895358 — Phase 3
Breast Cancer Research Study Groups: Placebo + Chemotherapy, Pembrolizumab + Chemotherapy
Breast Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04895358 — Phase 3
Capecitabine (Antimetabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895358 — Phase 3
~414 spots leftby Jul 2028
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