Clinical trial NCT05140655: Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm Female
Lead sponsor: Dr. Reddy's Laboratories SAS
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal Women with Advanced Breast Cancer HR+, HER2-

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: Measured at 12 months
measure: Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)
timeFrame: Measured at 12 months
measure: Overall survival rate
timeFrame: 12 months
measure: Disease-free survival rate
timeFrame: 12 months
Secondary outcomes:
measure: Describe the demographic characteristics of the patients included in the study
timeFrame: Measured at 12 months
measure: Assess percentage of patients with adverse events (assessed by CTCAEv4.0) from the first administration and until the end of follow-up.
timeFrame: Measured at 12 months
measure: Assess Percentage of patients with serious adverse events (assessed by CTCAEv4.0) from the first administration to the end of follow-up.
timeFrame: Measured at 12 months
measure: Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.
timeFrame: Measured at 12 months
Other outcomes:
Locations:
city: Valledupar
country: Colombia
facility: SOHEC
state: Cesar
Study officials:
affiliation: SOHEC
name: Ray Manneh
role: PRINCIPAL_INVESTIGATOR
affiliation: IMAT
name: José Lobatón
role: PRINCIPAL_INVESTIGATOR
References: