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Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.

NCT03283384 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-19

No results posted yet for this study

Summary

The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Letrozole

Letrozole 2.5 mg daily.

DRUG

Chemotherapy

Dose dense AC-T chemotherapy: consisting of 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v. bolus, respectively) 2-weekly, plus G-CSF (6 mg once per cycle) 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m2 weekly).

DRUG

Ribociclib plus letrozole

Ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks).

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Philips Healthcare

    collaborator INDUSTRY

  • Borstkanker Onderzoek Groep

    lead NETWORK

Principal Investigators

  • Judith R Kroep, MD PhD · Leiden University Medical Center

  • Sabine C Linn, Prof. MD · NKI-AvL

  • Gerrit-Jan Liefers, MD PhD · Leiden University Medical Center

  • A. E van Leeuwen-Stok, PhD · BOOG Study Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2022-12-06
Completion
2027-08-31

Countries

  • Netherlands

Study Locations

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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 NCT03283384 on ClinicalTrials.gov