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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Drug: Fulvestrant

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Juan Molina; Phone Number: 3134981879; Email: juanpablo@drreddys.com
• Study Contact Backup: Name: Juan Molina; Phone Number: +573134981879; Email: juanpablo@drreddys.com

Study Locations

• Colombia
  • Cesar
    • Valledupar, Cesar, Colombia
      • Recruiting
      • SOHEC
      • Contact: Ray Manneh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal Women with Advanced Breast Cancer HR+, HER2-

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Common Terminology Criteria for Adverse Events	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	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	Measured at 12 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories SAS
• Investigators: Principal Investigator: Ray Manneh, SOHEC; Principal Investigator: José Lobatón, IMAT

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): April 19, 2022
• Study Completion (Anticipated): August 19, 2022

Study Registration Dates

• First Submitted: November 11, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Antagonists; Estrogen Receptor Antagonists; Fulvestrant
• Other Study ID Numbers: DRLCOLCT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No