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Aromatase Inhibitors

DRUG18 trials

Sponsors

Pfizer, Hellenic Breast Surgeons Society, Georgetown University, Institute of Cancer Research, United Kingdom, Consorzio Oncotech

Conditions

Advanced Breast CancerBreast CancerBreast Cancer FemaleBreast Cancer MetastaticBreast DiseasesBreast NeoplasmBreast NeoplasmsEarly-stage Breast Cancer

Phase 1

Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer
TerminatedNCT01484041
Georgetown UniversityBreast Cancer
Start: 2012-04-30End: 2017-12-31Updated: 2018-02-09
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Not yet recruitingNCT07596212
University of Illinois at ChicagoBreast Cancer, Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma +1
Start: 2026-05-01End: 2031-05-01Target: 100Updated: 2026-05-19

Phase 2

Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
CompletedNCT02760030
Ohio State University Comprehensive Cancer CenterEstrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative, Stage IA Breast Cancer +6
Start: 2017-02-16End: 2025-08-31Updated: 2025-12-19
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
CompletedNCT02970682
Evgen PharmaBreast Neoplasm
Start: 2016-10-31End: 2019-03-31Target: 60Updated: 2019-07-12
Evaluation of Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic Low Grade Endometrial Stromal Sarcoma (LGESS)
RecruitingNCT03624244
Centre Leon BerardLow Grade Endometrial Stromal Sarcoma
Start: 2019-01-23End: 2031-01-01Target: 40Updated: 2026-02-17
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer
NCT04088110
Fuzhou General HospitalBreast Cancer Female, Breast Diseases, HER2-positive Breast Cancer +3
Start: 2019-11-30End: 2023-11-30Target: 77Updated: 2019-09-12
Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7)
TerminatedNCT04227327
University of Milano BicoccaAdvanced Breast Cancer
Start: 2020-01-07End: 2024-07-25Updated: 2025-07-29
Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
CompletedNCT04240106
MedSIRBreast Cancer, Breast Cancer Metastatic
Start: 2020-06-15End: 2023-11-17Updated: 2024-02-16
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
CompletedNCT04352777
Duke UniversityHormone Receptor Positive Tumor, Locally Advanced Breast Cancer, Metastatic Breast Cancer
Start: 2020-09-14End: 2025-06-25Updated: 2025-07-20

Phase 3

Trial of Perioperative Endocrine Therapy - Individualising Care
Active, not recruitingNCT02338310
Institute of Cancer Research, United KingdomBreast Cancer
Start: 2008-09-30End: 2034-04-30Updated: 2020-02-17
Overcoming Endocrine Resistance in Metastatic Breast Cancer
NCT02394496
Consorzio OncotechMetastatic Breast Cancer
Start: 2007-11-30End: 2017-01-31Target: 396Updated: 2016-06-15
Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
CompletedNCT02511639
Istituto Oncologico Veneto IRCCSBreast Cancer Metastatic
Start: 2014-07-30End: 2020-07-31Updated: 2020-12-03
Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women
NCT02914158
First Affiliated Hospital, Sun Yat-Sen UniversityBreast Cancer
Start: 2016-03-30End: 2025-12-31Target: 680Updated: 2023-01-17
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection
CompletedNCT03079011
UNICANCERMetastatic Breast Cancer
Start: 2017-03-22End: 2025-09-22Updated: 2025-11-18

Phase 4

HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
NCT03111615
Centro Hospitalar Lisboa OcidentalBreast Cancer Female, Hormone Dependent Neoplasms
Start: 2018-05-01End: 2020-05-01Target: 90Updated: 2017-12-05

Unknown Phase

Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
CompletedNCT00784888
PfizerBreast Neoplasms
Start: 2008-06-30End: 2011-12-31Updated: 2012-03-15
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
CompletedNCT01298362
Hellenic Breast Surgeons SocietyBreast Cancer, Other Disorders of Bone Density and Structure
Start: 2011-03-31End: 2014-03-31Updated: 2016-09-20
Effects of Testosterone and Fat Utilization
CompletedNCT03289559
University of Colorado, DenverHealthy, Volunteers
Start: 2006-01-01End: 2014-01-01Updated: 2017-09-21

Related Papers

Abstract P1-02-16: Matched pair single-cell RNA-sequencing highlights the impact of abemaciclib and endocrine therapy on different myeloid cell populations in advanced ER+/HER2- breast cancer
Clinical Cancer Research2025-06-13
Niraparib Plus Aromatase Inhibitors for Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer with a Germline BRCA Mutation
Cancers2025-05-22
Molecular profiling after short-term preoperative endocrine therapy to identify oestrogen receptor positive (ER+)/HER2+ early breast tumours with favourable prognosis.
Journal of Clinical Oncology2024-05-29
260P LUZERN: Phase II trial of niraparib and aromatase inhibitors (AI) for pretreated hormone receptor-positive/HER2-negative germline BRCA-mutated advanced breast cancer
ESMO Open2024-05-011 citations
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
Evaluating the role of aromatase inhibitors (AIs) in the treatment of endometrial stromal sarcomas (ESS).
Journal of Clinical Oncology2021-05-201 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
Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial.
2020-11-01220 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 OT1-04-01: Adjuvant ovarian suppression plus aromatase inhibitor or tamoxifen for hormone receptor-positive breast cancer in women younger than 35 (ASPAIT): A multicenter randomized clinical trial
Cancer Research2020-02-15
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

7 more papers not shown