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

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT04251169
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jul 21, 2020
Status verified
May 2025
Primary completion
Apr 10, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Paclitaxel
    Pembrolizumab 200 mg every 3 weeks (on Day 1 \[D1\] of each 21-day cycle, beginning in Cycle 1) in combination with paclitaxel 80 mg/m² administered at Days 1, 8, and 15 of each 21-day cycle beginning at Cycle 2.

Primary Outcome Measure

Overall Response Rate of Pembrolizumab in Combination With Paclitaxel in HR+/HER2- Non-luminal Subtype Advanced Breast Cancer Defined by the PAM50 Assay [ Time Frame: From the date of randomization to disease progression, death, unacceptable toxicity, consent withdrawal, or study termination, whichever occurred first, assessed for up to 33 months. ]

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