Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
NCT05524584 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-03-11
Summary
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.
Conditions
Interventions
- DRUG
-
Given intramuscularly
- DRUG
-
Anastrozole
Given orally
- DRUG
-
Given orally
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Rita Mehta, MD · Chao Family Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-31
- Primary Completion
- 2028-12-31
- Completion
- 2031-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer
NCT02216786 ·Status: COMPLETED ·Phase: PHASE2
-
Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer
NCT00138125 ·Status: TERMINATED ·Phase: PHASE2
-
MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women With Metastatic Breast Cancer
NCT01344031 ·Status: COMPLETED ·Phase: PHASE1
-
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NCT05191004 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
NCT02152943 ·Status: COMPLETED ·Phase: PHASE1
-
Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery
NCT02760030 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
NCT02924883 ·Status: COMPLETED ·Phase: PHASE2
-
Anti-HER2 Therapy + Fulvestrant/Capecitabine in Women With HR+, HER2+, Non-visceral Metastases Stage IV Breast Cancer
NCT04337658 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
NCT05720260 ·Status: RECRUITING ·Phase: PHASE2
-
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
NCT02540330 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
NCT02384239 ·Status: COMPLETED ·Phase: PHASE2
-
Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
NCT02219789 ·Status: COMPLETED ·Phase: PHASE1
-
Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer
NCT00405938 ·Status: COMPLETED ·Phase: PHASE2
-
Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
NCT01142401 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate in Molecular Apocrine Breast Cancer
NCT01842321 ·Status: COMPLETED ·Phase: PHASE2
-
Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
NCT03633331 ·Status: COMPLETED ·Phase: PHASE2
-
Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic
NCT00003440 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer
NCT06515470 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
NCT02605915 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
NCT01797120 ·Status: COMPLETED ·Phase: PHASE2
-
Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer
NCT03128619 ·Status: TERMINATED ·Phase: PHASE1
-
Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer
NCT02690480 ·Status: UNKNOWN ·Phase: PHASE2
-
Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer
NCT01394211 ·Status: TERMINATED ·Phase: PHASE2
-
Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer
NCT00354640 ·Status: COMPLETED ·Phase: PHASE2
-
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
NCT00618657 ·Status: COMPLETED ·Phase: PHASE2