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CTRI Number  CTRI/2023/11/059490 [Registered on: 03/11/2023] Trial Registered Prospectively
Last Modified On: 02/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the efficacy & safety of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia 
Scientific Title of Study   A prospective efficacy & safety study of intravenous Ferric Carboxy Maltose in breast cancer patients with iron deficiency anemia 
Trial Acronym  FCM study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Manjunath Nookala  
Designation  Associate Professor, Dept. of Clinical Pharmacology  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  919920703438  
Fax    
Email  nk.manjunath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Manjunath Nookala  
Designation  Associate Professor, Dept. of Clinical Pharmacology  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  919920703438  
Fax    
Email  nk.manjunath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Manjunath Nookala  
Designation  Associate Professor, Dept. of Clinical Pharmacology  
Affiliation  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  
Address  Dept. of Clinical Pharmacology, ACTREC, Tata Memorial Hospital, Navi Mumbai


MAHARASHTRA
410210
India 
Phone  919920703438  
Fax    
Email  nk.manjunath@gmail.com  
 
Source of Monetary or Material Support  
Emcure pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd 
Address  Plot P-II, IT-BT Park, M.I.D.C., Hinjawadi, Pune- 411 057 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath Nookala Krishnamurthy  Tata Memorial Centre (TMH and ACTREC)  Department of Clinical Pharmacology, Room No. KS 102, Khanolkar Shodhika, Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA 
9920703438

nk.manjunath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (4) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (6) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (7) ICD-10 Condition: C506||Malignant neoplasm of axillary tail of breast, (8) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (9) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj.Ferric Carboxy Maltose  Inj. Ferric Carboxy Maltose is given as 1 gram injection over a period of 10-15 infusion 
Comparator Agent  This is a single arm trial  There is no comparator in this study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of IV Ferric CarboxyMaltose in breast cancer patients with iron deficiency anaemia  Change in the Haemoglobin level at 30±7 days from immediate preFCM Haemoglobin leve 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the safety of IV Ferric CarboxyMaltose in breast cancer
patients with iron deficiency anaemia
 
-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 anaemia 
Change in the patient’s quality of life at 30±7 days after the administration of IV FCM from immediate pre-FCM Haemoglobin level 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide with 2.26 million [95% UI, 2.24–2.79 million] new cases in 2020. Anaemia in cancer patients is still a relevant problem and is the most common complication in them. Anaemia affects both general health and quality of life.  It has an incidence rate ranging from 22.7% to 63% and increasing to 89% following chemotherapy. It can be classified into two important forms: (1) anaemia occurring as an adverse event consequent to the toxic effect of anticancer treatment (chemotherapy-induced anaemia”) and (2) anaemia occurring as a manifestation of the disease itself, more aptly called “cancer related anaemia,” resulting from systemic processes and immune system activation in cancer. Anaemia may be induced by the direct myelotoxic effect of the chemotherapeutic agents or indirectly by drug-induced renal damage resulting in low levels of erythropoietin (EPO). FCM is reported to be safe and effective in providing a rapid correction of serum ferritin levels and Hb in IDA patients. Despite the availability of several other iron formulations like LMW Iron dextran, Ferric gluconate, and Ferumoxytol, the use of FCM has improved the physical performance and quality of life in iron-deficient patients compared to other iron formulations FCM is reported to be with occurrence of less adverse events compared to other formulations. This study attempts to assess the safety and efficacy of IV FCM in increasing the Hb in IDA in Breast Cancer patients who are on follow-up and thereby decreasing eventual and inevitable blood transfusions. It will be a prospective, non-randomized, single-arm study in breast cancer patients with iron deficiency anaemia (IDA) who have completed chemotherapy and are in follow-up stage.  
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