Improving blood management for breast cancer patients undergoing surgery
Official title: Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer
Run by Regina Elena Cancer Institute · NCT06883201 · Data updated 2026-11-12
This study tests whether giving iron treatment before surgery can help breast cancer patients with low hemoglobin levels need fewer blood transfusions during their operations.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 78 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Status | Recruiting |
| Started | January 31, 2023 |
| Main results expected | June 30, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT06883201 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with histologically confirmed breast cancer and low hemoglobin levels, who are scheduled for breast surgery.
✕Probably not a fit
Patients with known allergies to ferric carboxymaltose, high ferritin levels, or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of preoperative anemia treatment in breast cancer patients to reduce the need for blood transfusions during surgery. It focuses on patients with hemoglobin levels of 11 g/dL or lower, who may have undergone neoadjuvant chemotherapy. The approach involves optimizing hematopoiesis through intravenous iron treatment, aiming to minimize transfusion-related risks and improve surgical outcomes. The study is observational and assesses transfusion rates in a clinical setting.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions in breast cancer patients, leading to better surgical outcomes and fewer transfusion-related complications.
How similar studies have gone: Other studies have shown that preoperative anemia management can effectively reduce transfusion rates, indicating a promising approach in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years; * patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy; * patients who are candidates for destructive and reconstructive breast surgery or not; * Hb values less than or equal to 11 g/dL and/or transferrin saturation less than or equal to 20%; * written informed consent. Exclusion Criteria: * patients with known allergies to ferric carboxymaltose or its excipients; * ferritin values greater than 500 ng/ml; * patients unable to sign consent and comply with procedures.
Where it's running
-
"Regina Elena" National Cancer Institute
Rome, Italy Recruiting
Study contacts
- Study coordinator: Giuseppina A. Natale, Doctor
- Email: giuseppina.natale@ifo.it
- Phone: 06-52662984
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.