NCT05140655

Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-

Real-world Effectiveness and Safety of a Generic Fulvestrant Alone or in Combination With Cyclin Inhibitors in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-, in Two Colombian Referral Centers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Dr. Reddy's Laboratories SAS · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Neoplasm Female

Interventions

Type	Name	Description
DRUG	Fulvestrant	Medicine for Advanced breast cancer

Timeline

• Start date: 2021-04-19
• Primary completion: 2022-04-19
• Completion: 2022-08-19
• First posted: 2021-12-01
• Last updated: 2021-12-01

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated drug study