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Principal Investigator


Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital (在職)

Division of General Surgery

更新時間：2023-09-19

高捷妮
  • Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

26Cases

篩選

Developmental Phase

  • Phase I

  • Phase I/II

  • Phase II

  • Phase II/III

  • Phase III

  • Phase IV

  • Others

Trial Status

  • Not yet recruiting

  • Active

  • Completed

Recruitment Status

  • Not yet recruiting

  • Recruiting

  • Completed

  • Terminated

  • Stop recruiting

  • Suspended

  • Study ended

Trial scale

  • Multi-Regional Multi-Center

  • Taiwan Multiple Center

  • Taiwan Single Center

The expected start time interval of the test

-

Trial Applicant

  • Hospital/Foundation

  • Pharmaceutical/Biopharmaceutical company

  • Contract Research Organization

Important Roles

  • Asia Regional PI

  • Taiwan National PI

  • Chairman/Global PI

  • Steering Committee

  • Advisory board

  • None

Audit by Sponsors/CRO

  • Sponsors

  • CRO

  • None

Investigator-initiated trial(IIT)

  • Yes

Filters

高捷妮

List

33Cases

2022-12-01 - 2024-09-09

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2022-10-01 - 2026-12-31

Phase III

Active
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

  • Condition/Disease

    Triple Negative Breast Cancer、PD-L1 Positive

  • Test Drug

    Sacituzumab Govitecan

Participate Sites
8Sites

Not yet recruiting3Sites

Recruiting5Sites

2023-06-30 - 2029-02-28

Phase III

Active
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

  • Condition/Disease

    Locally Advanced or Unresectable Metastatic Breast Cancer、 Stage IV Breast Cancer

  • Test Drug

    注射劑

Participate Sites
10Sites

Recruiting10Sites

2024-01-01 - 2026-12-31

Phase III

Active
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

  • Condition/Disease

    Metastatic Breast Cancer

  • Test Drug

    膜衣錠

Participate Sites
7Sites

Recruiting7Sites

2022-03-01 - 2027-08-31

Phase III

Active
A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

  • Condition/Disease

    HER2 Positive Breast Cancer

  • Test Drug

    錠劑

Participate Sites
14Sites

Recruiting14Sites

2023-10-02 - 2026-12-31

Phase III

Completed
A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

  • Condition/Disease

    HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients

  • Test Drug

    PERT-IJS (Bmab 1500)

Participate Sites
7Sites

Recruiting7Sites

2020-09-24 - 2025-12-31

Phase III

Active
A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With HR+/ HER2- Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens

  • Condition/Disease

    Metastatic Breast Cancer

  • Test Drug

    Sacituzumab govitecan

Participate Sites
8Sites

Not yet recruiting6Sites

Recruiting2Sites

2020-12-01 - 2025-12-31

Phase I

Completed
EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

  • Condition/Disease

    ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

  • Test Drug

    LY3484356

Participate Sites
7Sites

Recruiting7Sites

2022-01-10 - 2028-12-01

Phase III

Active
postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy

  • Condition/Disease

    Breast Neoplasm Neoplasm Metastasis

  • Test Drug

    Abemaciclib

Participate Sites
6Sites

Recruiting6Sites

2020-10-15 - 2027-09-01

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
13Sites

Recruiting13Sites

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