Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
- Conditions
- Breast Cancer Stage IV
- Interventions
- Registration Number
- NCT04852081
- Lead Sponsor
- Blokhin's Russian Cancer Research Center
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with HR+, HER2- advanced or metastatic breast cancer Ribociclib patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Palbociclib patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Letrozole patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Abemaciclib patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Anastrozole patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Tamoxifen patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Fulvestrant patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Exemestane patients with HR+, HER2- advanced or metastatic breast cancer patients with HR+, HER2- advanced or metastatic breast cancer Alpelisib patients with HR+, HER2- advanced or metastatic breast cancer
- Primary Outcome Measures
Name Time Method To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow 12 months The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
- Secondary Outcome Measures
Name Time Method Proportion of patients among study population who have with symptomatic visceral metastasis 12 months Proportion of patients among study population who have with symptomatic visceral metastasis
Proportion of patients among study population who have treatment-emergent Adverse Events 12 months Proportion of patients among study population who have treatment-emergent Adverse Events
Proportion of premenopausal women among study population 12 months Proportion of premenopausal women among study population
percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment 12 months percentage of obtaining tumor specimens and reevaluating targeted markers in breast cancer patients who relapsed after curative treatment
Proportion of patients among study population who have visceral metastasis 12 months Proportion of patients among study population who have visceral metastasis
Evaluation of the outcome per treatment line 12 months To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival
Trial Locations
- Locations (1)
N.N. Blokhin National Medical Research Center of Oncology
🇷🇺Moscow, Russian Federation