Pembrolizumab + Chemotherapy for Breast Cancer

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1.

Eligibility Criteria

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.

Inclusion Criteria

My breast cancer is HR+/HER2-, not treated with chemotherapy for advanced stages.

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer has worsened after hormone therapy, and I am now eligible for chemotherapy.

My cancer has worsened despite the last hormone therapy I received.

I have provided a recent biopsy from a cancer area not treated with radiation.

My breast cancer is HR+ and HER2- with a PD-L1 CPS of 1 or more.

Exclusion Criteria

I have been treated with immunotherapy before.

I have a BRCA mutation and haven't been treated with PARP inhibitors.

I have an active case of tuberculosis.

I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

I have received an organ or tissue transplant from another person.

I am currently being treated for an infection.

My cancer is only in my skin.

I have had chemotherapy for breast cancer that has returned or spread and cannot be removed by surgery.

I am severely allergic to pembrolizumab or its ingredients, or to the chemotherapy I plan to receive.

I have active cancer spread to my brain or spinal cord.

My breast cancer can be treated with the goal of curing it.

I haven't had radiotherapy or needed steroids for side effects in the last 2 weeks.

I have a serious heart condition.

My cancer has spread to other organs and is causing symptoms.

I haven't had cancer treatment with experimental drugs in the last 4 weeks.

I have or had lung inflammation that needed steroids.

I have been treated for an autoimmune disease in the last 2 years.

I have been diagnosed with cancer in the lining of my brain and spinal cord.

I have been diagnosed with HIV.

I have tested positive for COVID-19.

Treatment Details

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).

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.

Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Xeloda for: