Health Condition 1: C500- Malignant neoplasm of nipple and areola Health Condition 2: C501- Malignant neoplasm of central portion of breast Health Condition 3: C502- Malignant neoplasm of upper-innerquadrant of breast Health Condition 4: C503- Malignant neoplasm of lower-innerquadrant of breast Health Condition 5: C504- Malignant neoplasm of upper-outerquadrant of breast Health Condition 6: C505- Malignant neoplasm of lower-outerquadrant of breast Health Condition 7: C506- Malignant neoplasm of
Conditions
Interventions
Intervention1: Inj.Ferric Carboxy Maltose: Inj. Ferric Carboxy Maltose is given as 1 gram injection over a period of 10-15 infusion
Control Intervention1: This is a single arm trial: There is no compa
Sponsors
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine the safety of IV Ferric CarboxyMaltose in breast cancer patients with iron deficiency anaemia Timepoint: -Incidence of all grade adverse events -Incidence of Grade 3/4 adverse events;To study the impact of IV Ferric Carboxy Maltose on the quality of life of metastatic breast cancer patients with iron deficiency anaemiaTimepoint: Change in the patientâ??s quality of life at 30±7 days after the administration of IV FCM from immediate pre-FCM Haemoglobin level | — |
Countries
India
Contacts
Public ContactDr K Manjunath Nookala
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Outcome results
None listed