NCT04517318

Brief Summary

To evaluate the prescription patterns and treatment outcomes of subsequent therapies after progression on palbociclib in the real world.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 15, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

3.7 years

First QC Date

August 16, 2020

Last Update Submit

August 1, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • PFS

    Progression free survival

    6 weeks

  • Adverse events

    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

    6 weeks

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

You may qualify if:

  • woman, age \> 18 years old
  • Diagnosed with HR+/HER2- Metastatic Breast Cancer
  • Patients received at least one-cycle next-line treatment after progression on combined palbociclib and endocrine therapy
  • Complete medical history was available

You may not qualify if:

  • \. Medical history was incomplete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Li Y, Li W, Gong C, Zheng Y, Ouyang Q, Xie N, Qu Q, Ge R, Wang B. A multicenter analysis of treatment patterns and clinical outcomes of subsequent therapies after progression on palbociclib in HR+/HER2- metastatic breast cancer. Ther Adv Med Oncol. 2021 Jun 11;13:17588359211022890. doi: 10.1177/17588359211022890. eCollection 2021.

    PMID: 34178122DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

August 15, 2017

Primary Completion

April 15, 2021

Study Completion

July 15, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Locations

CN(1)