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CompletedNCT03695341Updated Jun 18, 2019

500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI

An observational study in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-18.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
130
Ages
18 Years and older
Sex
Female
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Study summary

500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Read the detailed description

Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

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Conditions studied

  • Breast Cancer

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Keywords

  • Endocrine Therapy
  • Fulvestrant
  • Everolimus
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 130 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
  2. Patients who were refractory to previous Aromatase Inhibitors
  3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01
  4. Available medical history

Exclusion criteria

Exclusion Criteria:

1.Incomplete medical history

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
130 participants (actual)
Patient registry
No

Groups and cohorts

  • Fulvestrant

    Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15

  • Everolimus plus Exemestane

    Everolimys 10 mg or 5 mg daily; Exemestane 25mg per day

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What researchers measure

Primary outcomes

  1. PFS

    Progression free survival

    Time frame: 6 weeks

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 6 weeks

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Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
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References and documents

Publications

  • Li Y, Xie Y, Gong C, Zhao Y, Zhang J, Zhang S, Wang L, Chen S, Hu X, Wang B. Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. Ther Clin Risk Manag. 2020 Jun 30;16:607-615. doi: 10.2147/TCRM.S255365. eCollection 2020. PubMed 32636632 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03695341
Lead sponsor
Fudan University
Responsible party
Biyun Wang, MD (Professor, Fudan University) — Principal investigator
First posted
Oct 4, 2018
Start date
May 14, 2018
Primary completion
Mar 10, 2019
Completion
May 15, 2019
Last update
Jun 18, 2019

Study contacts

Biyun Wang, Professor
principal investigator · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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