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Adjuvant Palbociclib in Elderly Patients With Breast Cancer

NCT03609047 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2026-05-12

No results posted yet for this study

Summary

Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

Conditions

  • Breast Cancer Stage II
  • Breast Cancer Stage III

Interventions

DRUG

Palbociclib

CDK4/6 inhibitor

DRUG

Docetaxel / cyclophosphamide

Adjuvant Chemotherapy

DRUG

doxorubicin/cyclophosphamide

Adjuvant Chemotherapy

DRUG

epirubicin/cyclophosphamide

Adjuvant Chemotherapy

DRUG

paclitaxel

Adjuvant Chemotherapy

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Swedish Association of Breast Oncologists

    collaborator UNKNOWN

  • ETOP IBCSG Partners Foundation

    collaborator NETWORK

  • German Adjuvant Breast Cancer Group

    collaborator OTHER

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • UNICANCER

    collaborator OTHER

  • Gruppo Oncologico Italiano di Ricerca Clinica

    collaborator OTHER

  • Breast International Group

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Hans Wildiers, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Jordan
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT03609047 on ClinicalTrials.gov