Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Alpelisib | Drug | Alpelisib | ALIAS |
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Palbociclib | Drug | Palbociclib | ALIAS |
| Ribociclib | Drug | Ribociclib | ALIAS |
| Tamoxifen |
Design
Arms and outcomes
Arms (1)
- label
- patients with HR+, HER2- advanced or metastatic breast cancer
- description
- patients with HR+, HER2- advanced or metastatic breast cancer
- interventionNames
- Drug: Palbociclib
- Drug: Ribociclib
- Drug: Abemaciclib
- Drug: Letrozole
- Drug: Anastrozole
- Drug: Tamoxifen
- Drug: Fulvestrant
- Drug: Exemestane
- Drug: Alpelisib
Primary outcomes (1)
- measure
- To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Moscow
- timeFrame
- 12 months
- description
- The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available