Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy (NCT07671547) | Clinical Trial Compass
CompletedPhase 2/3
Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy
79 participantsStarted 2014-01-01
Plain-language summary
The goal of this clinical trial is to learn if Naderin works to prevent low white blood cell counts in people with breast cancer receiving first-line chemotherapy. The main questions it aims to answer are:
1. Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy?
2. Does taking Naderin help people finish all of their chemotherapy treatments without interruptions? Researchers will compare people who receive chemotherapy with Naderin to people who receive chemotherapy alone to see if Naderin helps prevent low white blood cell counts.
Participants will:
Receive standard AC chemotherapy for breast cancer Either receive Naderin along with chemotherapy or receive chemotherapy alone Have regular blood tests to check white blood cell counts Complete all 4 chemotherapy cycles
Key finding: The study found that 14 out of 100 people who received Naderin developed low white blood cell counts, compared to 39 out of 100 people who did not receive Naderin.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed histological diagnosis of breast cancer
Receiving first-line AC chemotherapy (doxorubicin + cyclophosphamide)
Age 18 years or older
Female sex
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow function (absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L)
Adequate hepatic function (transaminases ≤ 2.5 × upper limit of normal)
Adequate renal function (creatinine ≤ 1.5 × upper limit of normal)
Normal cardiac function (left ventricular ejection fraction ≥ 50%)
Willing and able to provide written informed consent
Exclusion Criteria:
* Previous chemotherapy or radiotherapy for breast cancer
History of other malignant neoplasms (except non-melanoma skin cancer or carcinoma in situ of the cervix)
Severe organ dysfunction (cardiac, hepatic, renal, pulmonary)
Active infection requiring systemic therapy
Known hypersensitivity to Naderin or any of its components
Known hypersensitivity to doxorubicin, cyclophosphamide, or any excipients
Pregnancy or breastfeeding
Psychiatric or cognitive impairment that would interfere with study participation
Participation in another interventional clinical trial within 30 days prior to enrollment
Any condition that, in the investigator's opinion, would compromise participant safety or interfere with study objectives
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of leukopenia during chemotherapy
Timeframe: Through chemotherapy completion, up to 4 months