Breast Cancer Stage IV Clinical Trial
Official title:
Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitors Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive, HER2-negative advanced breast cancer.
Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive, HER2-negative advanced (recurrent or metastatic) breast cancer. The investigators will use data from patients treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology. Eligible patients will be of 18 years or older, women of any menopausal status with HR-positive/HER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer. Treatment combinations of CDKi with any endocrine therapy will be accepted. Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi. Patient clinical data will be obtained from their medical records. Toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits. Statistical analysis The primary endpoint of the study will be progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Secondary endpoint will be overall survival (OS), defined as the time from treatment initiation to patient death or last contact. Patients alive will be censored at the date of last contact. Adverse events will be graded based on Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04469127 -
A Phase I/II Multicenter, Open-Label Study of Lu-177-DOTAGA-IAC, for the Treatment of Angiogenic Breast Cancer Patients.
|
Phase 1/Phase 2 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05377047 -
Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer
|
N/A | |
Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
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 |
NCT05559528 -
BRaziLian outcomE for metAStatic breasT Cancer
|
||
Active, not recruiting |
NCT05090358 -
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05033925 -
Ficus Septica Leaves Fraction as a Complementary Therapy for Stadium IV Breast Cancer Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT03401359 -
The Resistance and Immune Response to Palbociclib in Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03870919 -
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
|
N/A | |
Not yet recruiting |
NCT05860907 -
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
|
Phase 4 | |
Completed |
NCT00393341 -
Quantitation of Endothelial Progenitor Cells as Markers of Tumor Angiogenesis in Breast Cancer
|
N/A | |
Recruiting |
NCT05625087 -
Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib
|
Phase 2 | |
Completed |
NCT04566458 -
RWD Study in HER2+ mBC Patients in Third-Line Therapy
|
||
Recruiting |
NCT06075810 -
A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04697043 -
The Benefit of Surgery in Stage IV of Breast Cancer
|
N/A | |
Recruiting |
NCT05837533 -
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
|
N/A | |
Active, not recruiting |
NCT03324425 -
Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05670054 -
Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients
|
Phase 3 |