Health Condition 1: E611- Iron deficiency Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: 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, administ
60 mg = 5 tabs per day split BID or TID as tolerated).
The duration of the intervention is 12 weeks
Sponsors
Basavatarakam Indo American Cancer Hospital & Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 supportTimepoint: Week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| mean HBTimepoint: Weeks 4, 8, 10, 12;Proportion receiving RBC transfusionTimepoint: from randomization to 30 days post-chemo;Proportion of subjects maintaining relative doseintensity of chemotherapy more than 85 percentageTimepoint: from randomization to chemotherapy completion;Patient reported fatigue & QoL measured with FACT - anemia scaleTimepoint: at baseline, week 4, week 10, end of chemotherapy | — |
Countries
India
Contacts
Public ContactRakesh Pinninti
Basavatarakam Indo-American Cancer Hospital and Research Institute
Outcome results
None listed