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

NCT ID: NCT04852081

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

Palbociclib

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)

Letrozole

Intervention Type: DRUG

Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.

Anastrozole

Intervention Type: DRUG

Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.

Tamoxifen

Intervention Type: DRUG

Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.

Fulvestrant

Intervention Type: 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

Intervention Type: DRUG

Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.

Alpelisib

Intervention Type: DRUG

Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Abemaciclib

Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)

Intervention Type: DRUG

Letrozole

Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.

Intervention Type: DRUG

Anastrozole

Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.

Intervention Type: DRUG

Tamoxifen

Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.

Intervention Type: 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.

Intervention Type: DRUG

Exemestane

Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.

Intervention Type: DRUG

Alpelisib

Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.

Intervention Type: DRUG

Other Intervention Names

Ibrance; Kisqali; VERZENIO; Faslodex; Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.; PIQRAY

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergei Tjulandin

Role: PRINCIPAL_INVESTIGATOR

N.N. Blokhin National Medical Research Center of Oncology

Locations

N.N. Blokhin National Medical Research Center of Oncology

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Vera Karaseva

Role: CONTACT

Karaseva@russco.org

+7 (499) 686-02-37

Marina Stenina

Role: CONTACT

Facility Contacts

Sergei Tjulandin, MD PhD

Role: primary

stjulandin@mail.ru

+74993249874

Other Identifiers

01-2021

Identifier Type: -

Identifier Source: org_study_id