CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Pembrolizumab administered every three weeks; Nab-Paclitaxel administered every weekAI-extracted
Key inclusion· 6
  • Histologically or cytologically confirmed invasive breast cancer
  • Operable breast cancer ≥2 cm, no distant metastatic disease (inflammatory breast cancer permitted)
  • Hormone receptor-positive (ER>1% or PR>1%), HER2-negative per ASCO CAP guidelines 2013
  • Age ≥18 years
Key exclusion· 6
  • Prior pembrolizumab or any anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy
  • History or evidence of active, non-infectious pneumonitis or interstitial lung disease
  • Uncontrolled intercurrent illness including uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmia, CHF (NYHA Class III-IV), active ischemic heart disease, MI within 6 months, uncontrolled diabetes, chronic liver/renal disease, or severe malnutrition
  • Active autoimmune disease or documented history of autoimmune disease/syndrome requiring systemic steroids or immunosuppressive agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02999477
NCT02999477Phase 1Completed

A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Adrienne G. Waks·interventional·Posted Dec 21, 2016·Updated Jan 29, 2026

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab, Nab-Paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 32 participants across 1 site.

Detailed Summary

This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer. The interventions involved in this study are: * Pembrolizumab (MK-3475; Keytruda™) * Nab-Paclitaxel (Abraxane

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 21, 2016
Enrollment StartFeb 23, 2017
Primary CompletionNov 20, 2022
Study CompletionJan 8, 2026
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 9.5 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab will be administered in clinic every three weeks.

Nab-Paclitaxeldrug

Nab-Paclitaxel will be administered in clinic every week.

Biopsyprocedure

Biopsies for research purposes will be performed at three separate timepoints during treatment.