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Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy

NCT04130152 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-10-25

No results posted yet for this study

Summary

PROMETEO II is a single-arm window of opportunity trial to evaluate biologic and anti-proliferative effects of palbociclib and letrozole in HR+/HER2-negative operable breast cancer (BC) patients with residual disease after neoadjuvant chemotherapy (NAC) and help to identify biomarkers for better patient selection.

Conditions

Interventions

DRUG

Palbociclib

Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle

DRUG

Letrozole

Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-21
Primary Completion
2022-01-26
Completion
2022-02-24

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT04130152 on ClinicalTrials.gov