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

NCT04852081 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-04-21

No results posted yet for this study

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

Conditions

  • Breast Cancer Stage IV

Interventions

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.

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Principal Investigators

  • Sergei Tjulandin · N.N. Blokhin National Medical Research Center of Oncology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852081 on ClinicalTrials.gov