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

Sponsor
Blokhin's Russian Cancer Research Center
Study ID
NCT04852081
Status
Unknown

Conditions

  • Breast Cancer Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib — DRUG
    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
  • Ribociclib — DRUG
    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
  • Abemaciclib — DRUG
    Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)
  • Letrozole — DRUG
    Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.
  • Anastrozole — DRUG
    Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.
  • Tamoxifen — DRUG
    Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.
  • Fulvestrant — DRUG
    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.
  • Exemestane — DRUG
    Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
  • Alpelisib — DRUG
    Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.

Study Details

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

Key Dates

Start date
Jan 1, 2021
Status verified
Apr 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: patients with HR+, HER2- advanced or metastatic breast cancer
    patients with HR+, HER2- advanced or metastatic breast cancer

Primary Outcome Measure

To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow [ Time Frame: 12 months ]

Central Contacts

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