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

NCT05140655 | Unknown FDA Drug

• 1 other identifier: DRLCOLCT001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  12 months

Secondary Outcomes (4)

• Describe the demographic characteristics of the patients included in the study

  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.

  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.

  Measured at 12 months

• Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.

  Measured at 12 months

Interventions

Fulvestrant DRUG

Medicine for Advanced breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal Women with Advanced Breast Cancer HR+, HER2-

You may qualify if:

• 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
• Diagnosis of advanced breast cancer HR +, HER2-
• Positivity for hormone receptors (either estrogen, progesterone, or both).
• Negative for human epidermal growth factor receptor 2 (HER2).
• Acceptance of informed consent, if it is required by local regulatory standards.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Reddy's Laboratories SAS: lead

Study Sites (1)

SOHEC

Valledupar, Cesar Department, Colombia

RECRUITING

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ray Manneh

  SOHEC

  PRINCIPAL INVESTIGATOR

• José Lobatón

  IMAT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Molina

CONTACT

3134981879; juanpablo@drreddys.com

Juan Molina

CONTACT

+573134981879; juanpablo@drreddys.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 1, 2021
• Study Start: April 19, 2021
• Primary Completion: April 19, 2022
• Study Completion: August 19, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)