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Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)

NCT06525675 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 419

Last updated 2024-12-13

No results posted yet for this study

Summary

The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with Human Epidermal growth factor Receptor 2 (HER2)-negative, Endocrine Receptor (ER)-positive metastatic breast cancer. It was designed to test the superiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib first and then the non-inferiority of fulvestrant plus palbociclib compared with letrozole plus palbociclib if the superiority objective was not achieved.

Conditions

Interventions

DRUG

Fulvestrant Injectable Product

500 mg fulvestrant on days 1, 14, 28, and once monthly thereafter, administered intramuscularly.

DRUG

Letrozole 2.5mg

2.5 mg letrozole per day, administered orally (continuous treatment)

DRUG

Palbociclib 125mg

orally administration 125 mg palbociclib per day (in cycles of 3 weeks of treatment followed by 1 week off)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart · Arnau de Vilanova Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2024-05-26
Completion
2024-09-02
FDA Drug
Yes

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT06525675 on ClinicalTrials.gov