Phase 4
Completed N=83
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Locally Advanced or · Breast Cancer
Source: ClinicalTrials.gov NCT02447328 ↗
Enrolled (actual)
83
Serious AEs
11.1%
Results posted
Mar 2018
Primary outcomePrimary: Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) — 81.5; 38.3; 11.1; 0 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions) |
81.5; 38.3; 11.1; 0; 71.6; 24.7 | — |
Eligibility Criteria
Inclusion Criteria
- Post menopausal status women
- Outpatient or inpatient with locally advanced or metastatic breast cancer who have failed with prior anti-estrogen therapy.
- Estrogen receptor positive
- Radiographic progression of disease after the prior therapy
- Patients who agree to participate in this study and sign the informed consent
Exclusion Criteria
- Patients who are treated with fulvestrant
- Patients who are being treated with the other antitumor agents
- Pregnancy or lactating women
- History of hypersensitivity to any of included ingredients (eg. Castor oil)
- Patients who are considered not fit for the study by investigators
- Patients who have severe dysfunction of liver or kidney
Data sourced from ClinicalTrials.gov (NCT02447328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.