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Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression

NCT04251169 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-03

Study results available
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Summary

This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (hereafter referred to as HR+/HER2-) breast cancer who had recurrence or progression while receiving previous therapy with a cyclin-dependent kinase (CDK) inhibitor in the adjuvant setting or to treat advanced disease (or both).

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg will be administered as a 30-minute intravenous (IV) infusion every 3 weeks beginning in Cycle 1

DRUG

Paclitaxel

Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab

Sponsors & Collaborators

Principal Investigators

  • Aleix Prat, MD, PhD · Hospital Clinic, Barcelona, Spain

  • Eva Ciruelos, MD, PhD · Hospital 12 de Octubre, Madrid, Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2024-04-10
Completion
2024-04-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251169 on ClinicalTrials.gov