NCT04852081

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer in Russia: A Multicentre Retrospective Observational Real-life Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib is in the form of oral capsules. Palbociclib, capsule, 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food
DRUG	Ribociclib	Ribociclib, tablets, 600mg orally (three 200 mg tablets)taken once daily with or without food for 21 consecutive days followed by 7 days off treatment
DRUG	Abemaciclib	Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)
DRUG	Letrozole	Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.
DRUG	Anastrozole	Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.
DRUG	Tamoxifen	Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.
DRUG	Fulvestrant	Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.
DRUG	Exemestane	Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
DRUG	Alpelisib	Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-04-21
• Last updated: 2021-04-21

Locations

1 site across 1 country: Russia