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.

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Stage IV
• Intervention / Treatment: Drug: Letrozole; Drug: Palbociclib; Drug: Ribociclib; Drug: Abemaciclib; Drug: Anastrozole; Drug: Tamoxifen; Drug: Fulvestrant; Drug: Exemestane; Drug: Alpelisib

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

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Vera Karaseva; Phone Number: +7 (499) 686-02-37; Email: Karaseva@russco.org
• Study Contact Backup: Name: Marina Stenina

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115478
    • Recruiting
    • N.N. Blokhin National Medical Research Center of Oncology
    • Contact: Sergei Tjulandin, MD PhD; Phone Number: +74993249874; Email: stjulandin@mail.ru
    • Principal Investigator: Sergei Tjulandin, MD PhD
    • Sub-Investigator: Marina Stenina, MD PhD
    • Sub-Investigator: Ludmila Zhukova, MD PhD
    • Sub-Investigator: Daniil 4. Stroyakovsky, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with histologically or cytologically confirmed luminal (HR positive/HER2 negative) inoperable locally advanced or metastatic breast cancer

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Drug: Letrozole; Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.; 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; Other Names: Ibrance; 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; Other Names: Kisqali; Drug: Abemaciclib; Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1); Other Names: VERZENIO; 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.; Other Names: Faslodex; Drug: Exemestane; Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.; Other Names: 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.; Other Names: PIQRAY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow	The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients among study population who have with symptomatic visceral metastasis	Proportion of patients among study population who have with symptomatic visceral metastasis	12 months
Proportion of patients among study population who have treatment-emergent Adverse Events	Proportion of patients among study population who have treatment-emergent Adverse Events	12 months
Proportion of premenopausal women among study population	Proportion of premenopausal women among study population	12 months
percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment	percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment	12 months
Proportion of patients among study population who have visceral metastasis	Proportion of patients among study population who have visceral metastasis	12 months
Evaluation of the outcome per treatment line	To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival	12 months

Collaborators and Investigators

• Sponsor: Blokhin's Russian Cancer Research Center
• Investigators: Principal Investigator: Sergei Tjulandin, N.N. Blokhin National Medical Research Center of Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (ACTUAL): April 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HR +, HER2-negative metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Hormone Antagonists; Bone Density Conservation Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Estrogen Receptor Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Fulvestrant; Palbociclib; Tamoxifen; Anastrozole; Exemestane
• Other Study ID Numbers: 01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No