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Fulvestrant Injectable Product

DRUG3 trials

Sponsors

UNICANCER, Tianjin Medical University Cancer Institute and Hospital, MedSIR

Conditions

Advanced Breast CancerBreast CancerER-positive Breast CancerFulvestrantHER2-negative Breast CancerLuminal Breast CancerMetastatic Breast CancerPalbociclib

Phase 3

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
CompletedNCT03079011
UNICANCERMetastatic Breast Cancer
Start: 2017-03-22End: 2025-09-22Updated: 2025-11-18

Unknown Phase

Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China
NCT04526028
Tianjin Medical University Cancer Institute and HospitalBreast Cancer, Fulvestrant, Palbociclib
Start: 2019-09-13End: 2023-05-31Target: 612Updated: 2020-08-25
Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)
CompletedNCT06525675
MedSIRAdvanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer +2
Start: 2022-07-18End: 2024-09-02Updated: 2024-12-13

Related Papers

Dynamics and type of <i>ESR1</i> mutations under aromatase inhibitor or fulvestrant combined with palbociclib after randomization in the PADA-1 trial.
Journal of Clinical Oncology2023-06-0111 citations
Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial.
2022-09-29215 citations
Real-Time Detection of ESR1 Mutation in Blood by Droplet Digital PCR in the PADA-1 Trial: Feasibility and Cross-Validation with NGS
Analytical Chemistry2022-04-1325 citations
Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1
BMJ Open2022-03-0143 citations
Abstract GS3-05: Fulvestrant-palbociclib vs continuing aromatase inhibitor-palbociclib upon detection of circulating <i>ESR1</i> mutation in HR+ HER2- metastatic breast cancer patients: Results of PADA-1, a UCBG-GINECO randomized phase 3 trial
Cancer Research2022-02-1531 citations
Abstract P1-07-01: Real time detection of ESR1 mutation in blood by droplet digital PCR in the PADA-1 trial: Feasibility and cross-validation with NGS
Cancer Research2022-02-151 citations
Abstract P1-18-16: First line aromatase inhibitor (AI) + palbociclib with randomized switch to fulvestrant + palbociclib upon detection of circulating <i>ESR1</i> mutation in HR+ HER2- metastatic breast cancer patients: Global safety results of PADA-1, a UCBG-GINECO phase III trial
Cancer Research2022-02-151 citations
Abstract CT189: Characterization of <i>ESR1</i> mutations at metastatic relapse and outcome under first line aromatase inhibitor and palbociclib in the PADA-1 trial
Cancer Research2021-07-013 citations
Efficacy of AI and palbociclib in ER+ HER2- advanced breast cancer patients relapsing during adjuvant tamoxifen: An exploratory analysis of the PADA-1 trial.
Journal of Clinical Oncology2021-05-201 citations
Risk of early progression according to circulating ESR1 mutation, CA-15.3 and cfDNA increases under first-line anti-aromatase treatment in metastatic breast cancer.
2020-05-2828 citations
Prognostic impact of ESR1 mutations in ER+ HER2- MBC patients prior treated with first line AI and palbociclib: An exploratory analysis of the PADA-1 trial.
Journal of Clinical Oncology2020-05-2049 citations
Abstract P5-11-22: Clinical and biological efficacy of first line AI and palbociclib in ER+ HER2- MBC with detectable circulating <i>ESR1</i> mutation prior to treatment initiation
Cancer Research2020-02-15
Abstract SY31-02: Clinical utility trials for CTC and ctDNA in ER+ advanced breast cancer
Cancer Research2019-07-011 citations
Abstract SY31-02: Clinical utility trials for CTC and ctDNA in ER+ advanced breast cancer
Clinical Research (Excluding Clinical Trials)2019-07-01
Abstract PD2-06: Circulating <i>ESR1</i> mutation detection rate and early decrease under first line aromatase inhibitor and palbociclib in the PADA-1 trial (UCBG-GINECO)
Cancer Research2019-02-1510 citations
Abstract P4-01-20: Circulating tumor DNA as a predictive biomarker of response to palbociclib-fulvestrant in patients with estrogen receptor-positive, HER2-negative metastatic breast cancer
Cancer Research2019-02-15
Abstract 3867: Activating <i>ESR1</i> mutations detection by single ddPCR assay
Cancer Research2018-07-011 citations
PADA-1: A randomized, open label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with hormone therapy driven by circulating DNA <i>ESR1</i> mutation monitoring in ER-positive, HER2-negative metastatic breast cancer patients.
Journal of Clinical Oncology2018-05-2011 citations