MedTrace Logo

Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -

NCT03819010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-11-27

No results posted yet for this study

Summary

This is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial.

Conditions

Interventions

DRUG

Pre treatment Recurrence Score:18-25 Letrozole + Palbociclib

Letrozole(2,5 mg/day during 28 days of each Cycle) + Palbociclib(125mg/day during 21 days of each cycle of 28 days) as neoadjuvant treatment during 6 cycles before surgery of Breast Cancer for patients with pre-treatment recurrence Score of 18-25

DRUG

Pre treatment Recurrence Score:26-100 Letrozole + Palbociclib

Letrozole(2,5 mg/day during 28 days of each Cycle) + Palbociclib(125mg/day during 21 days of each cycle of 28 days) as neoadjuvant treatment during 6 cycles before surgery of Breast Cancer for patients with pre-treatment recurrence Score of 26-100

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart, PdH · MedSIR

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2019-07-30
Completion
2019-12-31

Countries

  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases
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 NCT03819010 on ClinicalTrials.gov