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Clinical Trials List

Protocol NumberWO42312
NCT Number(ClinicalTrials.gov Identfier)NCT04576455
Active

2020-12-01 - 2025-12-31

Phase II

Recruiting5

ICD-10D05.00

Lobular carcinoma in situ of unspecified breast

ICD-10D05.01

Lobular carcinoma in situ of right breast

ICD-10D05.02

Lobular carcinoma in situ of left breast

ICD-10D05.10

Intraductal carcinoma in situ of unspecified breast

ICD-10D05.11

Intraductal carcinoma in situ of right breast

ICD-10D05.12

Intraductal carcinoma in situ of left breast

ICD-10D05.80

Other specified type of carcinoma in situ of unspecified breast

ICD-10D05.81

Other specified type of carcinoma in situ of right breast

ICD-10D05.82

Other specified type of carcinoma in situ of left breast

ICD-10D05.90

Unspecified type of carcinoma in situ of unspecified breast

ICD-10D05.91

Unspecified type of carcinoma in situ of right breast

ICD-10D05.92

Unspecified type of carcinoma in situ of left breast

ICD-9233.0

Carcinoma in situ of breast

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.

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ta-Chung Chao Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 馮盈勳 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Chang Lin Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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

Objectives

This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.

Test Drug

GDC-9545
Anastrozole
Fulvestrant
Letrozole
Exemestane

Active Ingredient

Giredestrant
Anastrozole
Fulvestrant
Letrozole
Exemestane

Dosage Form

Hard Capsule
film-coated tablets
Intramuscular injection
film-coated tablets
film-coated tablets

Dosage

30mg
1mg
50mg/ml
2.5mg
25mg

Endpoints

Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Inclution Criteria

1.Women who are postmenopausal or premenopausal/perimenopausal
2.For women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy for the duration of study treatment
3.Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
4.Documented ER-positive tumor and HER2-negative tumor, assessed locally
5.Disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting
6.Measurable disease as defined per RECIST v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by CT or MRI which can be followed
7.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
8/Adequate organ function

Exclusion Criteria

1.Prior treatment with a selective estrogen receptor degrader (SERD), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization
2.Treatment with any investigational therapy within 28 days prior to randomization
3.Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
4.Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
5.Active cardiac disease or history of cardiac dysfunction
6.Pregnant or breastfeeding

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    300 participants

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