Breast cancer outcomes improved with CDK4/6 inhibitor treatment

Questions To Ask Your Health Care Provider

• What treatment therapy or therapies are best for me?
• Should I consider treatment with a CDK4/6 inhibitor for my metastatic breast cancer?
• What side effects might I have with a CDK4/6 inhibitor?
• Should I have biomarker testing of my tumor?
• Are there clinical trials enrolling participants with metastatic breast cancer that are appropriate for me?

Open Clinical Trials

The following studies look at treatment for people with metastatic ER-positive breast cancer.  

• NCT04673448: Combining the Immunotherapy Dostarlimab and PARP Inhibitor Niraparib for Advanced or Metastatic Breast, Ovarian or Pancreatic Cancer with an Inherited or Tumor BRCA Mutation. This study examines the effectiveness of combining the PARP inhibitor niraparib and the immunotherapy dostarlimab for treating people with an inherited BRCA mutation (found with genetic testing) or a tumor mutation (found through tumor testing) who have advanced breast, pancreatic or ovarian cancer. 
• NCT05501886: Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1).  This study investigates the efficacy and safety of the selective estrogen receptor degrader (SERD) gedatolisib plus fulvestrant with or without palbociclib to treat patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
• NCT04975308: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3). This study evaluates the efficacy and safety of the selective estrogen receptor degrader (SERD) imlunestrant. Researchers will assess how it works compared to standard hormone therapy and how well it works when combined abemaciclib compared to imlunestrant in participants with breast cancer that is ER-positive and HER2-negative. 
• NCT05306340: A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer). This study evaluates the efficacy and safety of the selective estrogen receptor degrader (SERD) giredestrant, plus everolimus compared with exemestane plus everolimus in people with estrogen receptor ER-positive, HER2-negative locally advanced or metastatic breast cancer who have had previous treatment with a CDK4/6 inhibitor and hormone therapy.
• NCT03344965: Olaparib Expanded - Treating Metastatic Breast Cancer in People without gBRCA Mutations. This study looks at whether olaparib is also effective for treating metastatic breast cancer in people who do not have an inherited BRCA mutation. This study enrolls people with an inherited mutation in PALB2 or an acquired (tumor) mutation in BRCA1 or BRCA2.
• NCT03685331: Olaparib, Palbociclib and Fulvestrant for BRCA-Associated, ER/PR+/HER2-Negative Metastatic Breast Cancer. This study looks at the side effects and best dose of palbociclib when given with olaparib and fulvestrant for people with HR+/HER2-negative mBC who have a BRCA1 or BRCA2 mutation. 
• NCT04072952: ARV-471 Alone and in Combination With Palbociclib in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer. This dose escalation study will determine the safety and tolerability of ARV-471 alone and combined with palbociclib in people with ER+/HER2- locally advanced or metastatic breast cancer who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.
• NCT04448886: Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC. This study evaluates the safety and effectiveness of sacituzumab govitecan with or without pembrolizumab for metastatic HR-positive/HER2-negative breast cancer.
• NCT04563507: Combined Immunotherapies in Metastatic ER+ Breast Cancer. in this study, patients receiving standard first-line therapy (letrozole+palbociclib) for metastatic HR+ breast cancer are randomly assigned to also receive stereotactic body radiation therapy (SBRT) for each metastatic lesion.
• NCT04895358: Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Inoperable or Metastatic Breast Cancer (KEYNOTE-B49). The study investigates the safety and efficacy of pembrolizumab plus chemotherapy compared to chemotherapy alone to treat HR+/HER2- locally recurrent inoperable or metastatic breast cancer. 

Other clinical trials for people with breast cancer can be found here.

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The following studies look at treatment for people with advanced solid tumors. 

• NCT05252390: NUV-868 Alone and in Combination With PARP Inhibitors in Patients With Advanced Solid Tumors.This study tests the safety and effectiveness of the experimental drug NUV-868 alone and combined with a PARP inhibitor in people with advanced solid tumors. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
• NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of orally administered ceralasertib combined with chemotherapy regimens and/or novel anticancer agents for patients with advanced cancer. The study enrolls people with tumors that are HRD-positive or who have inherited mutations in BRCA1, BRCA2, ATM, RAD51C or RAD51D.  
• NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn whether treatment with a new PARP inhibitor, AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors. The study is open to people who have previously been treated with PARP inhibitors.  
• NCT04267939: ATR Inhibitor Plus Niraparib Study in Advanced Solid Tumors and Ovarian Cancer. This study looks at how well people with advanced solid tumors respond to treatment with the targeted therapy BAY1895344 in combination with the PARP inhibitor niraparib. This study is open to people with inherited mutations in ATM, BRCA1, BRCA2 and other genes. Contact the study coordinator for information about eligibility for people with mutations in other genes. 
• NCT04657068: Treatment with ATR Inhibitor for Advanced or Metastatic Solid Tumors. This study looks at how well a new oral targeted therapy known as an ATR inhibitor works on advanced or metastatic solid tumors with mutations in genes that are linked to DNA damage repair. This study is open to people who have an inherited or acquired BRCA or ATM mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.

 

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