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Principal Investigator


Linkou Chang Gung Medical Foundation (在職)

Division of Hematology & Oncology

Division of General Surgery

更新時間：2023-09-19

何蕙余
  • Co-Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

16Cases

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

何蕙余

List

23Cases

2023-04-01 - 2030-12-31

Phase III

Active
A PHASE III, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS FULVESTRANT VERSUS ALPELISIB PLUS FULVESTRANT IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE, PIK3CA MUTATED LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO PROGRESSED DURING OR AFTER CDK4/6 INHIBITOR AND ENDOCRINE COMBINATION THERAPY

  • Condition/Disease

    Patients with locally advanced or metastatic breast cancer who have PIK3CA mutations, are hormone receptor-positive, and HER2-negative

  • Test Drug

    GDC-0077(Inavolisib)Alpelisib(Piqray)Fulvestrant (Faslodex)

Participate Sites
6Sites

Not yet recruiting1Sites

Recruiting5Sites

2020-11-01 - 2027-12-31

Phase III

Active
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

  • Condition/Disease

    Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

  • Test Drug

    GDC-9545letrozolePalbociclib

Participate Sites
6Sites

Not yet recruiting3Sites

Recruiting3Sites

2020-12-01 - 2025-12-31

Phase II

Active
A Phase II, Randomized,Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared with physician's choice of endocrine monotherapy in Patients with Previously treated Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer.

  • Condition/Disease

    Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

  • Test Drug

    GDC-9545 Anastrozole Fulvestrant Letrozole Exemestane

Participate Sites
5Sites

Recruiting5Sites

2023-04-01 - 2031-04-25

Phase III

Active
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

  • Condition/Disease

    Breast Cancer

  • Test Drug

    Datopotamab deruxtecanDurvalumab

Participate Sites
9Sites

Not yet recruiting8Sites

Recruiting1Sites

2024-01-01 - 2028-12-31

Others

Active

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Recruiting8Sites

2021-03-16 - 2029-12-31

Phase III

Active
SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) plus Palbociclib versus Anastrozole plus Palbociclib for the Treatment of Patients with Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease

  • Condition/Disease

    AZD9833 AZD9833 is being developed for treatment of ER-positive, HER2-negative breast cancer. Anastrozole Arimidex is indicated for the: -Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. -Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women. -Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. Palbociclib IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: -in combination with an aromatase inhibitor; -in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.

  • Test Drug

    AZD9833 ArimidexR IbranceR

Participate Sites
10Sites

Recruiting9Sites

Terminated1Sites

2022-11-01 - 2030-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Not yet recruiting7Sites

Recruiting1Sites

2020-10-15 - 2025-12-31

Phase I/II

Active
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

  • Condition/Disease

    HER2-positive Metastatic Breast Cancer

  • Test Drug

    Trastuzumab deruxtecan (ENHERTUR)

Participate Sites
8Sites

Recruiting8Sites

2021-06-01 - 2026-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
11Sites

Not yet recruiting9Sites

Recruiting2Sites

2023-10-01 - 2033-02-05

Phase III

Active
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

  • Condition/Disease

    Breast Cancer

  • Test Drug

    Datopotamab deruxtecanDurvalumab

Participate Sites
8Sites

Recruiting8Sites

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