EUCTR2020-000119-66-IT进行中（未招募）1 期
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 - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 978
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •–Age >= 18 years at time of signing Informed Consent Form
- •–For women who are premenopausal or perimenopausal or 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
- •–No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
- •–Measurable disease as defined per RECIST v.1.1
- •–Eastern Cooperative Oncology Group Performance Status 0-1
- •–Adequate organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 391
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 587
排除标准
- •–Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an AI
- •–Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
- •–Prior treatment with a 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
研究者
相似试验
招募中
不适用
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, ANDIMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19-J98J98PER-059-20AstraZeneca AB,1,470
进行中（未招募）
1 期
A Study to Evaluate 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 CancerFirst line of treatment for Estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancerMedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10083232Term: HER2 negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000119-66-ATF. Hoffmann-La Roche Ltd978
进行中（未招募）
3 期
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast CancerPATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCEJPRN-jRCT2071200038Clinical trials information992
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2020-000791-38-NOF. Hoffmann-La Roche Ltd658
进行中（未招募）
1 期
A Study to Evaluate 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 CancerFirst line of treatment for Estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancerMedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: LLTClassification code 10070577Term: Oestrogen receptor positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 23.0Level: PTClassification code 10083232Term: HER2 negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000119-66-DEF. Hoffmann-La Roche Ltd978