NCT04047758

Brief Summary

Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018. Palbociclib combined with an aromatase inhibitor can be used to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer or metastatic breast cancer. This brings more treatment options for hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer. How to scientifically evaluate the efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor and to establish a more suitable treatment strategy for Chinese patients is one of the questions that need to be answered in clinical practice. This multi-center parallel-group randomized controlled trial will address on this issue.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_3 breast-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

August 5, 2019

Last Update Submit

July 18, 2021

Conditions

Breast Cancer

Keywords

palbociclibaromatase inhibitors

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    It is defined as the time from random assignment in a clinical trial to disease progression or death from any cause.

    24 months

Secondary Outcomes (3)

  • Overall survival

    24 months

  • Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)

    24 months

  • EuroQol five-dimension scale (ED-5Q)

    24 months

Study Arms (2)

Palbociclib + Letrozole group

EXPERIMENTAL

210 patients will be randomly assigned to receive treatment with palbociclib and letrozole (palbociclib + letrozole group) .

Drug: Palbociclib + Letrozole

Letrozole group

PLACEBO COMPARATOR

210 patients will be randomly assigned to receive treatment with letrozole (letrozole group).

Drug: Letrozole

Interventions

Palbociclib + LetrozoleDRUG

(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day, for 21 successive days, followed by 7 days off treatment \[3 weeks on (days 1-21) and 1 week off (days 22-28)\], repeated every 28 days. (2) Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.

Palbociclib + Letrozole group
LetrozoleDRUG

Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.

Letrozole group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histological and imaging findings-confirmed hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer;
  • postmenopausal patients;
  • eligible patients receiving one or more treatment strategies who are followed up in the center where they receive treatment;
  • provision of written informed consent.

You may not qualify if:

  • Age \< 18 years;
  • pregnant woman;
  • participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

Liaoning Provincial People's Hospital

Shenyang, Liaoning, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Caigang Liu

    Shengjing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Gu

CONTACT

+86-18940255116jadegx@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Breast Surgery

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 7, 2019

Study Start

September 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CN(3)