Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Objective response rate
- timeFrame
- Measured at 12 months
- description
- 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
- measure
- Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)
- timeFrame
- Measured at 12 months
- description
- CBR is the proportion of patients with a complete or partial response or with stable disease
- measure
- Overall survival rate
- timeFrame
- 12 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available