Clinical Trials Logo

Clinical Trial Summary

A assessment of the efficacy of first-/second-line endocrine therapies ± target therapies and chemotherapy in real-life of in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer has not yet been conducted in Moscow. Methods: Observational, retrospective study carried out in oncology hospitals in Moscow, in patients with hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer. The descriptive analysis will be conducted for patient characteristics, responses to treatment and treatment outcomes. This study will provide retrospective chart review of evidence on the use of therapy in routine clinical practice, with a focus in population of Moscow


Clinical Trial Description

The combination CDK4/6 inhibitors (CDK4/6i) (Palbociclib, Ribociclib and Abemaciclib) with endocrine therapy (ET, i.e. aro- matase inhibitors (AI) or Fulvestrant) has significantly increased objective response rate (ORR) and progression-free survival (PFS) of first- and second-line treatments in patients with hormone receptor positive, HER2 negative (luminal) mBC. Now this combination is the standard treatment for luminal mBC. Recommendation for endocrine therapy versus chemotherapy as first-line treatment of luminal mBC is endorsed by the main international guidelines such as ASCO and ESO-ESMO guidelines. Endocrine therapy should be used as initial treatment except in cases of immediately life-threatening disease, tumors refractory to endocrine therapy, visceral crisis, or rapid progressive disease that mandate a high response rate treatment. The aim of this study is to provide real-life treatment patterns data for luminal MBC with a focus in population of Moscow ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04852081
Study type Observational
Source Blokhin's Russian Cancer Research Center
Contact Vera Karaseva
Phone +7 (499) 686-02-37
Email Karaseva@russco.org
Status Recruiting
Phase
Start date January 1, 2021
Completion date December 1, 2021

See also
  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Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Withdrawn NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2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