A study to evaluate the efficacy & safety of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia

Not Applicable

• Registration Number: CTRI/2023/11/059490
• Lead Sponsor: Emcure Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Females 18 yrs or older

2. Histologically proven diagnosis of breast cancer patients on follow-up, rather than on ongoing chemotherapy.

3. Haemoglobin 8-10g/dl or transferrin saturation =20% regardless of the haemoglobin level.

Exclusion Criteria

1. Patients with other obvious known causes of anaemia like blood loss,

Megaloblastic anaemia, Pernicious anaemia, and Haemolytic anaemia

2. Patients who are a known case of uncontrolled hypertension, recent acute

illness, hematologic disorders, or those receiving any other experimental drug

3. Patients with a known significant dysfunction of pulmonary, cardiovascular,

endocrine, neurological, gastrointestinal, or genito-urinary systems not

attributable to underlying malignancy

4. Patients who are receiving Iron supplements in oral or parenteral forms

5. Patients who are on erythropoietin stimulating agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of IV Ferric CarboxyMaltose in breast cancer patients with iron deficiency anaemiaTimepoint: Change in the Haemoglobin level at 30±7 days from immediate preFCM Haemoglobin leve

Secondary Outcome Measures

Name	Time	Method
To determine the safety of IV Ferric CarboxyMaltose in breast cancer <br/ ><br>patients with iron deficiency anaemia <br/ ><br>Timepoint: -Incidence of all grade adverse events <br/ ><br>-Incidence of Grade 3/4 adverse events;To study the impact of IV Ferric Carboxy Maltose on the quality of life of <br/ ><br>metastatic breast cancer patients with iron deficiency anaemiaTimepoint: Change in the patient’s quality of life at 30±7 days after the administration of IV FCM from immediate pre-FCM Haemoglobin level