| CTRI Number |
CTRI/2026/02/104238 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
08/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing intravenous iron and oral iron to treat iron deficiency anemia in women with early breast cancer receiving chemotherapy |
|
Scientific Title of Study
|
BRIGHT-Fe Breast cancer Randomized trial of IV vs oral Iron (ferric derisomaltose vs iron polypeptide) for hemoglobin recovery, chemo dose intensity, and transfusion avoidance in early breast cancer.
|
| Trial Acronym |
BRIGHT-Fe |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Pinninti |
| Designation |
consultant medical oncology |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Medical Oncology
Room 118, Block 1, 1st floor, Basavatarakam Indoamerican Cancer Hospital
Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
7506150584 |
| Fax |
|
| Email |
pinninti.rakesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Pinninti |
| Designation |
consultant medical oncology |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Medical Oncology
OPD Room no. 118, Block 1, 1st floor
Basavatarakam Indoamerican Cancer Hospital
Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
7506150584 |
| Fax |
|
| Email |
pinninti.rakesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Pinninti |
| Designation |
consultant medical oncology |
| Affiliation |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
| Address |
Department of Medical Oncology,
OPD room no.118, Block 1, 1st floor, Basavatarakam Indoamerican Cancer Hospital
Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA
500034
India |
| Phone |
7506150584 |
| Fax |
|
| Email |
pinninti.rakesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basavatarakam Indo American Cancer Hospital & Research Institute - Intra mural grant
Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034 |
|
|
Primary Sponsor
|
| Name |
Basavatarakam Indo American Cancer Hospital & Research Institute |
| Address |
Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rakesh Pinninti |
Basavatarakam Indo American Cancer Hospital & Research Institute |
OPD 118, Block 1, 1st floor, Basavatarakam Indoamerican cancer Hospital
Road no 10 Banjara hills
Hyderabad
TELANGANA |
7506150584
pinninti.rakesh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
| InstitutionalEthicsCommittee |
Approved |
| InstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E611||Iron deficiency, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A IV iron Ferric derisomaltose |
Single infusion 1000 mg IV for patients with a weight of 50 kg or more (or 20 mg per kg for those less than 50 kg) over at least 20 minutes, administered before or early during the first chemotherapy cycle. Repeat dosing permitted as per clinical judgment. The duration of the intervention is 12 weeks |
| Comparator Agent |
Arm B, Oral Iron, Oral iron polypeptide (low dose daily strategy) |
Iron polypeptide tablets or capsules containing 12 mg elemental iron per unit. The daily elemental iron target range is 12 to 60 mg, implemented via a protocolized titration algorithm to balance efficacy and tolerability.
Starting dose 24 mg per day (2 12 mg capsules once daily with water).
b)Titration for intolerance (GI symptoms): Step down by 12 mg per day to 12 mg per day (1 12 mg capsule) and allow dosing with food if needed.
Titration for inadequate response: If Hb rise less than 1.0 g per dL from baseline by Week 2 to 4, increase by 12 mg per day increments up to maximum 60 mg per day (i.e., 1 to 5 tablets daily, suggested splits 36 mg or 3 tabs OD or 12 mg TID 48 mg or 2 tabs BID; 60 mg = 5 tabs per day split BID or TID as tolerated).
The duration of the intervention is 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically confirmed early breast cancer stage one to stage three
2. Hemoglobin (Hb) between 8.0 and 11.9 gm per dL at screening, and evidence of iron deficiency defined as Serum ferritin less than 100 ng per mL OR Serum ferritin 100 to 300 ng per mL with transferrin saturation less than 20%.
3. Planned to receive (neo)adjuvant systemic chemotherapy with curative intent
4. Chemotherapy planned starts within 1 week before or after randomization |
|
| ExclusionCriteria |
| Details |
1. Metastatic breast cancer or any incurable malignancy. Other active second malignancy (excluding adequately treated in-situ carcinoma of cervix, non-melanoma skin cancers, or other cancers in remission for more than 5 years).
2. Severe, uncontrolled comorbidities Uncontrolled heart failure, unstable angina, recent MI or stroke (e.g. within 6 months), severe uncontrolled hypertension (e.g. more than 180/110 despite therapy).
3. Active infection: Clinically significant uncontrolled infection requiring IV antibiotics at the time of randomization.
4. Recent transfusion, PRBC transfusion within 2 weeks before screening or randomization
5. Recent ESA use or Prior IV iron. IV iron administration within 8 weeks before randomization or planned IV iron outside the study protocol during the study period.
6. Other anemia etiologies, Known B12 or folate deficiency not corrected before inclusion. Known hemolytic anemia, aplastic anemia, myelodysplastic syndrome, or hemoglobinopathies (e.g. thalassemia major, sickle cell disease).
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the proportion of patients achieving a hemoglobin response, defined as an increase of more than 2 gm per dL from baseline or an absolute Hb more than or equal to 12 gm per dL without requiring transfusion support |
Week 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean HB |
Weeks 4, 8, 10, 12 |
| Proportion receiving RBC transfusion |
from randomization to 30 days post-chemo |
| Proportion of subjects maintaining relative doseintensity of chemotherapy more than 85 percentage |
from randomization to chemotherapy completion |
| Patient reported fatigue & QoL measured with FACT - anemia scale |
at baseline, week 4, week 10, end of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pinninti.rakesh@gmail.com].
- For how long will this data be available start date provided 16-02-2026 and end date provided 16-06-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is being conducted to compare two ways of treating anemia in women with early breast cancer who are receiving chemotherapy. Anemia is common during chemotherapy and may cause fatigue, weakness, blood transfusions, or delays in cancer treatment.
Eligible women aged 18 years or older with hemoglobin levels between 8 and 11.9 grams per deciliter will be randomly assigned to receive either a single dose of intravenous iron or daily oral iron tablets for about 12 weeks.
Blood tests will be performed at regular visits, including Week 2 Week 4 Week 8 and Week 10. The main outcome will be improvement in hemoglobin levels at Week 10. Participants will also complete short questionnaires about fatigue and quality of life.
The study aims to determine which treatment better improves anemia and helps patients complete chemotherapy without dose reductions or transfusions. Participation is voluntary and patients may withdraw at any time. Personal information will be kept confidential. |