Status:
UNKNOWN
Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Breast Cancer Stage IV
Eligibility:
All Genders
18+ years
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 bre...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04852081
Start Date
January 1 2021
End Date
December 1 2021
Last Update
April 21 2021
Active Locations (1)
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1
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia, 115478