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 Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 230
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Histologically confirmed early breast cancer stage one to stage three
- •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%.
- •Planned to receive (neo)adjuvant systemic chemotherapy with curative intent 4.
Exclusion Criteria
- •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).
- •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).
- •Active infection: Clinically significant uncontrolled infection requiring IV antibiotics at the time of randomization.
- •Recent transfusion, PRBC transfusion within 2 weeks before screening or randomization
- •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.
- •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).
Investigators
Rakesh Pinninti
Basavatarakam Indo-American Cancer Hospital and Research Institute