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

Blokhin's Russian Cancer Research Center

Status

Unknown

Conditions

Breast Cancer Stage IV

Treatments

Drug: Ribociclib

Drug: Palbociclib

Drug: Exemestane

Drug: Abemaciclib

Drug: Anastrozole

Drug: Fulvestrant

Drug: Tamoxifen

Drug: Alpelisib

Drug: Letrozole

Study type

Observational

Funder types

Other

Identifiers

NCT04852081

01-2021

Details and patient eligibility

About

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

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should be more than 10% ER positive or Allred ≥5 by local laboratory testing.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
Patient has inoperable locally advanced or metastatic breast cancer
Patient has adequate bone marrow and organ function
Patient must be physically well enough that they are capable of treatment

Exclusion criteria

Patient has severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may interfere with the interpretation of study results
no clinical and anamnestic information or information about safety or information about effectiveness treatment