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ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

NCT04603183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-12-12

No results posted yet for this study

Summary

This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.

Conditions

  • Breast Cancer Metastatic

Interventions

DRUG

Abemaciclib

Patients will receive abemaciclib 150 mg orally twice daily (BID) (300 mg daily, administered as six 50 mg tablets) during each 28 day cycle combined with either letrozole or fulvestrant.

DRUG

Paclitaxel

Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.

DRUG

Letrozole

Patients will receive 2.5 mg letrozole, orally administered and taken daily during each 28-day cycle combined with abemaciclib.

DRUG

Fulvestrant

Patients will receive 500 mg fulvestrant, by intramuscular \[IM\] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter combined with abemaciclib.

Sponsors & Collaborators

Principal Investigators

  • Antonio Llombart-Cussac · Arnau de Vilanova Hospital, Valencia (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Italy
  • Portugal
  • Spain

Study Locations

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Entities

Drugs
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 NCT04603183 on ClinicalTrials.gov