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Showing 1–24 of 30 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: CDK4/6i Clear all
Recruiting Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

NCT05646862
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Fulvestrant, Alpelisib, Bupropion, Omeprazole, Midazolam
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
420 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
39
States / cities
Greenbrae, California • Los Alamitos, California • Los Angeles, California + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Terminated Phase 2 Interventional Results available

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

NCT01953926
View directory record Official record
Conditions
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Interventions
Neratinib, Fulvestrant, Trastuzumab, Paclitaxel
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
582 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2023
U.S. locations
30
States / cities
Birmingham, Alabama • Phoenix, Arizona • Duarte, California + 26 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2024 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Not applicable Interventional

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

NCT05977036
View directory record Official record
Conditions
Metastatic Breast Cancer, Unresectable Breast Cancer
Interventions
DiviTum® TKa assay, CDK4/6 + Endocrine therapy
Device · Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2034
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Dec 16, 2025 · Synced Sep 23, 2026, 5:03 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT05563220
View directory record Official record
Conditions
Breast Cancer, Metastatic Breast Cancer
Interventions
Elacestrant, Alpelisib, Everolimus, Ribociclib, Palbociclib, Capivasertib, Abemaciclib
Drug
Lead sponsor
Stemline Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
435 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2028
U.S. locations
35
States / cities
Dothan, Alabama • Phoenix, Arizona • Springdale, Arkansas + 30 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting No phase listed Observational

Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer

NCT06666439
View directory record Official record
Conditions
Metastatic Invasive Lobular Carcinoma (mILC)
Interventions
circulating tumor DNA (ctDNA)
Diagnostic Test
Lead sponsor
Julia Foldi
Other
Eligibility
18 Years and older · Female only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 19, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Completed No phase listed Observational

A Study of Real-world Outcomes Among Patients Treated With Ribociclib

NCT07148505
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
373 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 28, 2025 · Synced Sep 23, 2026, 5:03 PM EDT
Completed No phase listed Observational

Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors

NCT05153135
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Ribociclib, Palbociclib, Abemaciclib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years · Female only
Enrollment
4,320 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 20, 2021 · Synced Sep 23, 2026, 5:03 PM EDT
Active, not recruiting Phase 2 Interventional

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

NCT05826964
View directory record Official record
Conditions
Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
Interventions
AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI, mTOR inhibitor + SERD, mTOR inhibitor + Selective estrogen receptor modulator, PI3K inhibitor + SERD, PI3K inhibitor + AI, Chemotherapy, Oral SERD, PARPi, AKT inhibitor, Step 3 Arm 2
Drug · Other
Lead sponsor
University of Miami
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Completed No phase listed Observational

A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors

NCT07647042
View directory record Official record
Conditions
Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
750 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 1Phase 2 Interventional

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

NCT05735080
View directory record Official record
Conditions
Breast Cancer, Breast Cancer Metastatic, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Ovarian Cancer, CCNE1 Amplification, Solid Tumor, Advanced Cancer, Metastatic Cancer
Interventions
INX-315, Fulvestrant, Abemaciclib
Drug
Lead sponsor
Incyclix Bio
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
15
States / cities
Orlando, Florida • Atlanta, Georgia • Augusta, Georgia + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 3 Interventional

Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

NCT06380751
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Saruparib (AZD5305), Camizestrant, Abemaciclib, Ribociclib, Palbociclib, Fulvestrant, Letrozole, Anastrozole, Exemestane
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years and older
Enrollment
788 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
57
States / cities
Gilbert, Arizona • Fountain Valley, California • Glendale, California + 49 more
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Completed No phase listed Observational

A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors

NCT07512063
View directory record Official record
Conditions
Breast Cancer
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older · Female only
Enrollment
480 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Apr 12, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

NCT06790693
View directory record Official record
Conditions
Breast Cancer
Interventions
Inavolisib, Placebo, CDK4/6i, Letrozole
Drug
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2032
U.S. locations
61
States / cities
Goodyear, Arizona • Phoenix, Arizona • Burbank, California + 49 more
Source: ClinicalTrials.gov public record
Updated Sep 2, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Active, not recruiting Phase 3 Interventional

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

NCT04862663
View directory record Official record
Conditions
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Interventions
Capivasertib, Fulvestrant, Palbociclib, Ribociclib, Abemaciclib
Drug
Lead sponsor
AstraZeneca
Industry
Eligibility
18 Years to 99 Years
Enrollment
893 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
40
States / cities
Tucson, Arizona • Fountain Valley, California • Glendale, California + 35 more
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 1 Interventional

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

NCT05683418
View directory record Official record
Conditions
HR+/HER2-negative Breast Cancer
Interventions
TOS-358, Fulvestrant, Palbociclib, Ribociclib
Drug
Lead sponsor
Totus Medicines
Industry
Eligibility
18 Years and older · Female only
Enrollment
241 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
9
States / cities
Chicago, Illinois • Boston, Massachusetts • Las Vegas, Nevada + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

NCT06065748
View directory record Official record
Conditions
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Interventions
Giredestrant, Fulvestrant, Abemaciclib, Palbociclib, Ribociclib, LHRH Agonist, FoundationOne Liquid CDx Assay (F1LCDx)
Drug · Diagnostic Test
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years and older
Enrollment
1,050 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
40
States / cities
Daphne, Alabama • Greenbrae, California • Harbor City, California + 34 more
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 1 Interventional

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399
View directory record Official record
Conditions
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
Interventions
NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
Drug
Lead sponsor
NiKang Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
361 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
18
States / cities
Duarte, California • La Jolla, California • Denver, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Aug 27, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Terminated No phase listed Observational Results available

HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

NCT04396626
View directory record Official record
Conditions
Breast Cancer
Interventions
Not listed
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
975 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 26, 2023 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 2 Interventional

A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

NCT07112053
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
Interventions
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine, Capecitabine, Computed Tomography, Cyclin-Dependent Kinase 4 Inhibitor, Cyclin-Dependent Kinase 6 Inhibitor, F-18 16 Alpha-Fluoroestradiol, Hormone Therapy, Positron Emission Tomography, Biopsy Procedure, Biospecimen Collection, Abemaciclib
Biological · Drug · Procedure
Lead sponsor
University of Washington
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Apr 5, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Terminated Phase 1 Interventional

(VELA) Study of BLU-222 in Advanced Solid Tumors

NCT05252416
View directory record Official record
Conditions
Advanced Solid Tumors, HR+ Breast Cancer, CCNE1 Amplification, HER2-negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Esophageal Adenocarcinoma, Carcinosarcoma
Interventions
BLU-222, Carboplatin, Ribociclib, Fulvestrant
Drug
Lead sponsor
Blueprint Medicines Corporation
Industry
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
19
States / cities
Little Rock, Arkansas • San Francisco, California • Stanford, California + 13 more
Source: ClinicalTrials.gov public record
Updated Nov 27, 2025 · Synced Sep 23, 2026, 5:03 PM EDT
Active, not recruiting Phase 3 Interventional

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

NCT06760637
View directory record Official record
Conditions
Breast Cancer
Interventions
PF-07220060, letrozole, abemaciclib, palbociclib, ribociclib
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
1,035 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2037
U.S. locations
218
States / cities
Birmingham, Alabama • Chandler, Arizona • Gilbert, Arizona + 135 more
Source: ClinicalTrials.gov public record
Updated May 18, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Completed Not applicable Interventional

Tka Assay for CDK4/6i

NCT06572800
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Interventions
DiviTum-TKa
Device
Lead sponsor
Yale University
Other
Eligibility
18 Years and older · Female only
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
18
States / cities
Derby, Connecticut • Fairfield, Connecticut • Glastonbury, Connecticut + 13 more
Source: ClinicalTrials.gov public record
Updated Oct 7, 2025 · Synced Sep 23, 2026, 5:03 PM EDT
Recruiting Phase 3 Interventional

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

NCT07492641
View directory record Official record
Conditions
HR+/HER2- Breast Cancer
Interventions
BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Drug
Lead sponsor
BeOne Medicines
Industry
Eligibility
18 Years and older
Enrollment
1,056 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2037
U.S. locations
58
States / cities
Birmingham, Alabama • Anchorage, Alaska • Fairbanks, Alaska + 54 more
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Sep 23, 2026, 5:03 PM EDT
Completed No phase listed Observational Results available

Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

NCT05361655
View directory record Official record
Conditions
Metastatic Breast Cancer
Interventions
Palbociclib + an aromatase inhibitor, Aromatase inhibitor
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
2,888 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 6, 2024 · Synced Sep 23, 2026, 5:03 PM EDT