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

• Conditions: Breast Neoplasm Female

• Registration Number: NCT05140655
• Lead Sponsor: Dr. Reddy's Laboratories SAS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-19
• Status Verified: 2021-11
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-30
• Last Update Submitted: 2021-11-30
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Primary Completion: 2022-04-19
• Study Completion: 2022-08-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Postmenopausal women (defined as those with permanent cessation of menstruation for more than 12 months, regardless of whether their menopausal condition occurred naturally or was artificially induced), ambulatory or hospitalized
2. Diagnosis of advanced breast cancer HR +, HER2-
3. Positivity for hormone receptors (either estrogen, progesterone, or both).
4. Negative for human epidermal growth factor receptor 2 (HER2).
5. Acceptance of informed consent, if it is required by local regulatory standards.

Exclusion Criteria

1. History of previous treatment with fulvestrant.
2. Concomitant treatment with antitumor drugs other than cyclin inhibitors (abemaciclib, palbociclib, ribociclib).
3. Pregnancy.
4. Lactation.
5. Hypersensitivity to any of the excipients included in the complete formulation of fulvestrant from Dr. Reddy's Laboratories Limited.
6. Renal insufficiency grade 4 or 5 (creatinine clearance <30 ml / min / 1.73 m2 according to the classification of the National Kidney Foundation).
7. Hepatic failure (Child-Pugh C stage).
8. Performance status ECOG ≥ 3.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate	Measured at 12 months	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
Disease-free survival rate	12 months	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
Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)	Measured at 12 months	CBR is the proportion of patients with a complete or partial response or with stable disease
Overall survival rate	12 months	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

Secondary Outcome Measures

Name	Time	Method
Assess percentage of patients with adverse events (assessed by CTCAEv4.0) from the first administration and until the end of follow-up.	Measured at 12 months	Common Terminology Criteria for Adverse Events
Describe the demographic characteristics of the patients included in the study	Measured at 12 months
Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.	Measured at 12 months	Common Terminology Criteria for Adverse Events
Assess Percentage of patients with serious adverse events (assessed by CTCAEv4.0) from the first administration to the end of follow-up.	Measured at 12 months	Common Terminology Criteria for Adverse Events

Trial Locations

Locations (1)

SOHEC; 🇨🇴 Valledupar, Cesar, Colombia