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

NCT05140655 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2021-12-01

No results posted yet for this study

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

DRUG

Fulvestrant

Medicine for Advanced breast cancer

Sponsors & Collaborators

  • Dr. Reddy's Laboratories SAS

    lead INDUSTRY

Principal Investigators

  • Ray Manneh · SOHEC

  • José Lobatón · IMAT

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-04-19
Completion
2022-08-19
FDA Drug
Yes

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140655 on ClinicalTrials.gov