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

Study Overview
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Brief Summary
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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
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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

Official Title
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Analysis of Therapy Sequence in Women With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer in Russia: A Multicentre Retrospective Observational Real-life Study.

Conditions
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Breast Cancer Stage IV

Intervention / Treatment
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* Drug: Palbociclib
* Drug: Ribociclib
* Drug: Abemaciclib
* Drug: Letrozole
* Drug: Anastrozole
* Drug: Tamoxifen
* Drug: Fulvestrant
* Drug: Exemestane
* Drug: Alpelisib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with HR+, HER2- advanced or metastatic breast cancer<br>patients with HR+, HER2- advanced or metastatic breast cancer | Drug: Palbociclib<br>* 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<br>* Other names: Ibrance;Drug: Ribociclib<br>* 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<br>* Other names: Kisqali;Drug: Abemaciclib<br>* Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)<br>* Other names: VERZENIO;Drug: Letrozole<br>* Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.<br>Drug: Anastrozole<br>* Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.<br>Drug: Tamoxifen<br>* Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.<br>Drug: Fulvestrant<br>* 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.<br>* Other names: Faslodex;Drug: Exemestane<br>* Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.<br>* Other names: Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.;Drug: Alpelisib<br>* Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.<br>* Other names: PIQRAY;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HR +, HER2-negative metastatic breast cancer