問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberBO41843
NCT Number(ClinicalTrials.gov Identfier)NCT04546009
Active

2020-11-01 - 2027-12-31

Phase III

Not yet recruiting3

Recruiting3

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 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

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet recruiting

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

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

Objectives

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

Test Drug

GDC-9545letrozolePalbociclib

Active Ingredient

GDC-9545
letrozole
Palbociclib

Dosage Form

capsule
capsule
capsule

Dosage

30mg
2.5mg
75mg or 100mg or 125mg

Endpoints

Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 78 months) ]

Inclution Criteria

Inclusion Criteria:

For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for the duration of study treatment
Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
Documented ER-positive tumor and HER2-negative tumor, assessed locally
Patients who have bilateral breast cancers which are both ER-positive and HER2-negative can be included in the study because the metastases are suitably targeted by the study treatments. If patients have bilateral tumors which are of different biomarker status, then proof of the ER and HER2 status of the metastases is required for study entry
No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
Disease recurrence from early-stage breast cancer after standard adjuvant endocrine therapy meeting the protocol-defined criteria of having received at least 24 months of treatment without disease progression during treatment and a disease-free interval since the completion of treatment that was greater than 12 months
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
Eastern Cooperative Oncology Group Performance Status 0-1
Adequate organ function

Exclusion Criteria

Exclusion Criteria:

Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an aromatase inhibitor (AI)
Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
Prior treatment with a selective estrogen receptor degrader (SERD)
Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen
Treatment with any investigational therapy within 28 days prior to study treatment
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Active cardiac disease or history of cardiac dysfunction
Pregnant or breastfeeding

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    978 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB