HER2-negative Breast Cancer Clinical Trial
Official title:
Phase II Trial Of Fulvestrant Plus Abemaciclib In Er-Positive, Her2-Negative Metastatic Breast Cancer Immediately After Failure Of A Cdk4/6 Inhibitor
The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
Endocrine therapy, including aromatase inhibitor therapy, is the primary treatment for ER-positive metastatic disease. Despite the effectiveness of this treatment, not all patients respond to it and many patients who are initially responsive to the drug, eventually develop resistance to it. The management of patients with ER-positive, HER2-negative metastatic breast cancer who experience disease progression after standard treatment (CDK4/6 inhibitor plus an aromatase inhibitor) is a significant challenge and identification of new therapeutic strategies for this population of patients remains an unmet clinical need. The aim of this research study is to determine if a month delay in the administration of the drug abemaciclib will be more effective than the drugs fulvestrant plus abemaciclib given together from the beginning for the treatment of ER-positive, HER2-negative metastatic breast cancer that has progressed on previous treatment. The study will investigate if a one month drug holiday from the CDK4/6 inhibitor drug, abemaciclib, will restore the body's sensitivity to the drug and make the subsequent treatment of abemaciclib plus fulvestrant more effective. This is a single arm study where patients will receive fulvestrant for 1 month, followed by abemaciclib and fulvestrant every 28 days. The treatment will be administered until disease progression or unacceptable toxicity. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
Completed |
NCT02371174 -
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
|
||
Completed |
NCT02225470 -
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
|
Phase 3 | |
Recruiting |
NCT05173103 -
Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
|
||
Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
Not yet recruiting |
NCT04498793 -
Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
|
Phase 2 | |
Completed |
NCT01705691 -
Comparison of Neoadjuvant Chemotherapy With Weekly Paclitaxel or Eribulin Followed by A/C in Women With Locally Advanced HER2-Negative Breast Cancer
|
Phase 2 | |
Terminated |
NCT01368263 -
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
|
Phase 2 | |
Recruiting |
NCT04576143 -
Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
|
Phase 2/Phase 3 | |
Completed |
NCT05054374 -
A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05467891 -
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
|
Phase 2 | |
Recruiting |
NCT04660435 -
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
|
||
Completed |
NCT02015559 -
Mucoadhesive Oral Wound Rinse in Preventing and Treating Stomatitis in Patients With ER- or PR-Positive Metastatic or Locally Recurrent Breast Cancer That Cannot be Removed by Surgery Receiving Everolimus
|
Phase 2 | |
Completed |
NCT04504916 -
A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002)
|
Phase 2 | |
Terminated |
NCT04738292 -
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
|
Phase 2 | |
Recruiting |
NCT05982093 -
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05396612 -
Role of the Immune Environment in Response to Therapy in Breast Cancer
|
||
Active, not recruiting |
NCT04595565 -
Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
|
Phase 3 | |
Terminated |
NCT01234532 -
Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery
|
Phase 2 | |
Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 |