Clinical trials: CDK4/6 Inhibitor
Advanced Solid Tumor, Advanced Breast Cancer
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
- Trial name
- NCT06997029
- Testing
- BMS-986500, Palbociclib, Fulvestrant
- Where
- 21 sites in United States, Denmark and 1 more
- Volunteers
- 234 people
- Sponsor
- Bristol-Myers Squibb
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial
This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease).
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
- Trial name
- NCT07191717
- Testing
- Abemaciclib, Biospecimen Collection, Imlunestrant
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Adjuvant Therapy, CDK4/6 Inhibitor
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated…
- Trial name
- BREAKER (NCT07180693)
- Where
- 18 sites in Italy
- Volunteers
- 750 people
- Sponsor
- European Institute of Oncology
Myelosuppression Adult, Chemotherapeutic Toxicity
Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC).
- Conditions
- Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer
- Trial name
- NCT04504513
- Testing
- Trilaciclib
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer, Familial Male, Radiotherapy; Complications
Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer
Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4/6 inhibitors, PARP inhibitors, capecitabine and PD1…
- Conditions
- Breast Cancer, Familial Male, Radiotherapy; Complications, Chemotherapeutic Toxicity, Immune Checkpoint Inhibitor
- Trial name
- RADIOCOM (NCT06197581)
- Testing
- Chest wall / breast radiation with or without lymph node region radiation.(For all of the enrolled patients)
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Metastatic Breast Cancer, Recurrent Ovarian Carcinoma
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
This is an open-label, multi-center, phase I study designed to assess the maximum tolerated dose of ribociclib and belinostat in combination.
- Trial name
- CHARGE (NCT04315233)
- Testing
- Ribociclib, Belinostat
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Utah
Breast Cancer
Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor
To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.
- Trial name
- NCT05276713
- Testing
- Tucidinostat
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing 302 Hospital
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy
The aim of the present study is to evaluate the efficacy and safety of palbociclib plus fulvestrant after failure of a combined treatment of hormonal therapy (aromatase inhibitor or tamoxifen ± LHRHa) plus a CDK4/6 inhibitor, in…
- Trial name
- NCT04318223
- Testing
- Palbociclib
- Where
- 19 sites in Italy
- Volunteers
- 168 people
- Sponsor
- Consorzio Oncotech
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Advanced Breast Cancer
Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)
CDK4/6 inhibitors are currently the standard treatment for female breast cancer patients with HR+ tumors. However, there is no established standard treatment for patients who experience treatment failure with CDK4/6 inhibitors.
- Trial name
- NCT05861830
- Testing
- The combination of Dalpiciclib with physician-selected endocrine therapy, Chemotherapy selected by the physician
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Peking Union Medical College Hospital
Solid Tumor
Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer
This is a single-arm, open-label, exploratory clinical study
- Trial name
- NCT05512780
- Testing
- Dalpiciclib
- Volunteers
- 30 people
- Sponsor
- Hebei Medical University Fourth Hospital
Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer
Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer
This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic…
- Conditions
- Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer, HER2-Negative Breast Cancer, Metastatic Epithelial Ovarian Cancer
- Trial name
- NCT03294694
- Testing
- Ribociclib, PDR001, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Dana-Farber Cancer Institute
Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.
- Conditions
- Hormone Receptor-Positive Breast Cancer, High-risk Breast Cancer, Early-Stage Breast Cancer, HER2-negative Breast Cancer
- Trial name
- DNADalHR (NCT06970912)
- Testing
- Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy, Taxane-Based Neoadjuvant Chemotherapy
- Where
- China
- Volunteers
- 393 people
- Sponsor
- Peking University People's Hospital
Breast Diseases, Breast Neoplasms
Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2…
- Conditions
- Breast Diseases, Breast Neoplasms, Dalpiciclib, Endocrine Breast Diseases
- Trial name
- NCT07581834
- Testing
- Dalpiciclib 125mg, Dalpiciclib 100mg, Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
- Where
- 2 sites in China
- Volunteers
- 2,000 people
- Sponsor
- Fujian Cancer Hospital
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Head and Neck Cancer, Locally Advanced
Palbociclib With Cetuximab and IMRT for Locally Advanced Squamous Cell Carcinoma
Cyclin D kinase 4 (CDK4) is a key regulator of the G1-S transition in the cell cycle. Alterations in CDK4-cyclin D-retinoblastoma (Rb) pathway may lead to carcinogenesis in many cancers.
- Trial name
- NCT03024489
- Testing
- Palbociclib, Cetuximab, Intensity Modulated Radiation Therapy
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- Mahidol University
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
Breast Neoplasm, Neoplasm Metastasis
Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred…
- Trial name
- postMONARCH (NCT05169567)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 138 sites in United States, Argentina and 15 more
- Volunteers
- 368 people
- Sponsor
- Eli Lilly and Company