An observational study in Breast Neoplasm Female, sponsored by Dr. Reddy's Laboratories SAS. Status unknown at 1 site in Colombia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Dr. Reddy's Laboratories SAS · Observational
A phase IV, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. All patients included will receive fulvestrant from Dr. Reddy's Laboratories, in accordance with local practice and the regulatory authorization of the drug in Colombia. This study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct.
Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria, will be evaluated to determine the effectiveness and tolerability of the administration of Dr. Reddy's fulvestrant at a dose of 500 mg / month plus an additional indicated dose 14 days after the initial dose, for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity. The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Dr. Reddy's Laboratories SAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Postmenopausal Women with Advanced Breast Cancer HR+, HER2-
Exclusion Criteria
Medicine for Advanced breast cancer
Objective response rate
Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)percentage of patients with complete response or partial response) according to RECIST 1.1
Time frame: Measured at 12 months
Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)
CBR is the proportion of patients with a complete or partial response or with stable disease
Time frame: Measured at 12 months
Overall survival rate
The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease
Time frame: 12 months
Disease-free survival rate
It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time
Time frame: 12 months
Describe the demographic characteristics of the patients included in the study
Time frame: Measured at 12 months
Assess percentage of patients with adverse events (assessed by CTCAEv4.0) from the first administration and until the end of follow-up.
Common Terminology Criteria for Adverse Events
Time frame: Measured at 12 months
Assess Percentage of patients with serious adverse events (assessed by CTCAEv4.0) from the first administration to the end of follow-up.
Common Terminology Criteria for Adverse Events
Time frame: Measured at 12 months
Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.
Common Terminology Criteria for Adverse Events
Time frame: Measured at 12 months
Plan to share: No
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This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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