Breast CancerPhase 2/3NADERIN-BCNCT07671547
Prophylaxis of Hematologic Complications With Naderin in First-Line Breast Cancer Chemotherapy
A Phase 2/3 study testing Naderin and AC Chemotherapy in people with Breast Cancer and Hematologic Disorder, run by MIPO Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hematologic Disorder, Leukopenia
- What is being tested?
- Naderin and AC Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
Official title: Medical Rehabilitation in Oncology: Prophylaxis of Hematologic and Immunologic Complications Using Naderin During First-Line Chemotherapy of Breast Cancer
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:
- Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy?
- 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.
Read more
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.
Read the detailed description
Study Rationale Myelosuppression and related immunologic complications are common dose-limiting toxicities of cytotoxic chemotherapy and can lead to treatment delays, dose reductions, or discontinuation. This study assessed prophylactic administration of Naderin (sodium deoxyribonucleate; immunomodulatory agent) as supportive care during first-line AC chemotherapy, with the intent to mitigate hematologic toxicity and preserve chemotherapy delivery.
Study Design and Setting This was a prospective, open-label, two-group interventional study conducted at the Kazakh Scientific Research Institute of Oncology and Radiology (Almaty, Kazakhstan) in collaboration with KazNMU and the Almaty Oncology Center. Treatment allocation was non-randomized and based on consecutive enrollment, treatment availability, and participant consent.
Study Groups and Interventions Control group: standard institutional AC chemotherapy (doxorubicin + cyclophosphamide), intravenous administration, 4 planned cycles.
Intervention group: the same AC chemotherapy regimen plus Naderin administered as a prophylactic adjunct with each chemotherapy cycle (route and dosing per local institutional protocol).
Concomitant medications and supportive care (including any antiemetics, antimicrobials, or use of colony-stimulating factors) were permitted according to institutional practice and recorded.
Assessments and Follow-up
Participants underwent:
Baseline evaluation prior to chemotherapy initiation, including clinical assessment and laboratory testing.
On-treatment monitoring during each AC cycle with serial complete blood counts and structured adverse-event assessment.
End-of-treatment evaluation after completion of planned chemotherapy cycles (or earlier discontinuation), including laboratory reassessment and documentation of chemotherapy delivery (cycle completion, delays, interruptions).
Outcomes (high-level; details recorded elsewhere) The study evaluated hematologic toxicity during chemotherapy and chemotherapy delivery feasibility (ability to complete planned cycles without interruption), along with safety/tolerability of adjunctive Naderin.
Statistical Approach (high-level) The primary between-group comparison for hematologic toxicity incidence was planned using categorical testing (chi-square) with a two-sided alpha threshold of 0.05, with descriptive summaries of chemotherapy delivery metrics and adverse events.
Ethical and Oversight Considerations The study was approved by the Local Ethics Committee of KazNMU (Approval No. 15677). Written informed consent was obtained from all participants prior to enrollment. No independent data monitoring committee was used.
- Being tested
- Naderin, AC Chemotherapy
- Keywords
- breast cancer, chemotherapy, Naderin, leukopenia, hematological complications, immunomodulation, medical rehabilitation, prophylaxis, AC chemotherapy, sodium deoxyribonucleate
- Medical subject headings
- Breast Neoplasms, Hematologic Diseases, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaderinDrug
Also called Sodium Deoxyribonucleate, Sodium nucleinate
Naderin is an immunomodulatory agent containing sodium deoxyribonucleate. It activates cellular and humoral immunity, stimulates reparative processes, and exhibits anti-inflammatory properties. It is administered locally alongside each chemotherapy cycle as prophylaxis against hematologic and immunologic complications. The agent is rapidly absorbed upon administration, distributed through lymphatic pathways to organs and tissues, and excreted primarily via the kidneys.
AC ChemotherapyDrug
Also called Doxorubicin and Cyclophosphamide
Standard first-line chemotherapy regimen consisting of doxorubicin (an anthracycline antibiotic) and cyclophosphamide (an alkylating agent). Administered intravenously for 4 cycles at standard institutional dosing. This is the backbone chemotherapy regimen for both study arms, with the experimental arm receiving Naderin as an adjunct prophylactic agent
| Study group | Role | What they receive |
|---|---|---|
| Naderin prophylaxis Group | Experimental | Participants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. In addition, participants receive Naderin (sodium deoxyribonucleate) as an adjunct prophylactic agent administered locally alongside each chemotherapy cycle to prevent hematologic and immunologic complications. Receives: Drug: Naderin |
| Chemotherapy alone Group | Active comparator | Participants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. Participants do not receive Naderin or any other prophylactic immunomodulatory agent. This group serves as the active comparator to evaluate the prophylactic effect of Naderin on hematologic complications. Receives: Drug: AC Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of leukopenia during chemotherapy
Proportion of participants who develop leukopenia (white blood cell count below the institutional lower limit of normal) during any of the 4 chemotherapy cycles. Leukopenia is defined as a decrease in circulating white blood cells below 4.0 × 10⁹/L (or per institutional laboratory reference range)
Measured: Through chemotherapy completion, up to 4 months
Secondary outcomes (5)
Chemotherapy completion rate
Proportion of participants who successfully complete all 4 planned cycles of AC chemotherapy without interruption, dose reduction, or premature discontinuation.
Measured: At the end of treatment, up to 4 months
Rate of chemotherapy interruption
Proportion of participants requiring chemotherapy interruption, dose delay, or premature discontinuation due to hematologic complications or other adverse events.
Measured: Through chemotherapy completion, up to 4 months
Requirement for colony-stimulating factors
Proportion of participants requiring administration of granulocyte colony-stimulating factors (G-CSF) for management of chemotherapy-induced neutropenia.
Measured: Through chemotherapy completion, up to 4 months
Quality of Life assessment
Change from baseline to end of chemotherapy in Global Health Status/Quality of Life (GHS/QoL) using EORTC QLQ-C30 (version 3.0). Scores are transformed to a 0-100 scale; higher scores indicate better QoL for GHS/QoL and functioning scales (and worse symptoms for symptom scales-if reported).
Measured: Baseline and at end of treatment, up to 4 months
All-cause mortality
Proportion of participants who died from any cause during the study period.
Measured: Through study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jan 2014
- Primary completion31 Dec 2015
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two parallel groups: the main group receives AC chemotherapy with Naderin, and the control group receives AC chemotherapy alone. Assignment is non-randomized based on consecutive enrollment and patient consent
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIPO Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Asfendiyarov Kazakh National Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671547
- Sponsor's protocol ID
- 7
- Other IDs
- Grant of KazNMU 2012
- Acronym
- NADERIN-BC
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Rehabilitation in Oncology: Prophylaxis of Hematologic and Immunologic Complications Using Naderin During First-Line Chemotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT07671547
- Acronym / sponsor ID
- NADERIN-BC / 7
- Keywords
- breast cancer, chemotherapy, Naderin, leukopenia, hematological complications, immunomodulation, medical rehabilitation, prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- MIPO ClinicUniversity, hospital or other
- Collaborators
- Asfendiyarov Kazakh National Medical University
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does taking Naderin lower the number of people who get low white blood cell counts during chemotherapy?
- 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.
Detailed description
Study Rationale Myelosuppression and related immunologic complications are common dose-limiting toxicities of cytotoxic chemotherapy and can lead to treatment delays, dose reductions, or discontinuation. This study assessed prophylactic administration of Naderin (sodium deoxyribonucleate; immunomodulatory agent) as supportive care during first-line AC chemotherapy, with the intent to mitigate hematologic toxicity and preserve chemotherapy delivery.
Study Design and Setting This was a prospective, open-label, two-group interventional study conducted at the Kazakh Scientific Research Institute of Oncology and Radiology (Almaty, Kazakhstan) in collaboration with KazNMU and the Almaty Oncology Center. Treatment allocation was non-randomized and based on consecutive enrollment, treatment availability, and participant consent.
Study Groups and Interventions Control group: standard institutional AC chemotherapy (doxorubicin + cyclophosphamide), intravenous administration, 4 planned cycles.
Intervention group: the same AC chemotherapy regimen plus Naderin administered as a prophylactic adjunct with each chemotherapy cycle (route and dosing per local institutional protocol).
Concomitant medications and supportive care (including any antiemetics, antimicrobials, or use of colony-stimulating factors) were permitted according to institutional practice and recorded.
Assessments and Follow-up
Participants underwent:
Baseline evaluation prior to chemotherapy initiation, including clinical assessment and laboratory testing.
On-treatment monitoring during each AC cycle with serial complete blood counts and structured adverse-event assessment.
End-of-treatment evaluation after completion of planned chemotherapy cycles (or earlier discontinuation), including laboratory reassessment and documentation of chemotherapy delivery (cycle completion, delays, interruptions).
Outcomes (high-level; details recorded elsewhere) The study evaluated hematologic toxicity during chemotherapy and chemotherapy delivery feasibility (ability to complete planned cycles without interruption), along with safety/tolerability of adjunctive Naderin.
Statistical Approach (high-level) The primary between-group comparison for hematologic toxicity incidence was planned using categorical testing (chi-square) with a two-sided alpha threshold of 0.05, with descriptive summaries of chemotherapy delivery metrics and adverse events.
Ethical and Oversight Considerations The study was approved by the Local Ethics Committee of KazNMU (Approval No. 15677). Written informed consent was obtained from all participants prior to enrollment. No independent data monitoring committee was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two parallel groups: the main group receives AC chemotherapy with Naderin, and the control group receives AC chemotherapy alone. Assignment is non-randomized based on consecutive enrollment and patient consent
| Arm | Type | Receives |
|---|---|---|
| Naderin prophylaxis Group | Experimental | Drug: NaderinParticipants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. In addition, participants receive Naderin (sodium deoxyribonucleate) as an adjunct prophylactic agent administered locally alongside each chemotherapy cycle to prevent hematologic and immunologic complications. |
| Chemotherapy alone Group | Active comparator | Drug: AC ChemotherapyParticipants in this arm receive standard first-line AC chemotherapy (doxorubicin + cyclophosphamide) for 4 cycles. Participants do not receive Naderin or any other prophylactic immunomodulatory agent. This group serves as the active comparator to evaluate the prophylactic effect of Naderin on hematologic complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaderinAlso: Sodium Deoxyribonucleate, Sodium nucleinateNaderin is an immunomodulatory agent containing sodium deoxyribonucleate. It activates cellular and humoral immunity, stimulates reparative processes, and exhibits anti-inflammatory properties. It is administered locally alongside each chemotherapy cycle as prophylaxis against hematologic and immunologic complications. The agent is rapidly absorbed upon administration, distributed through lymphatic pathways to organs and tissues, and excreted primarily via the kidneys. | Drug | Naderin prophylaxis Group |
| AC ChemotherapyAlso: Doxorubicin and CyclophosphamideStandard first-line chemotherapy regimen consisting of doxorubicin (an anthracycline antibiotic) and cyclophosphamide (an alkylating agent). Administered intravenously for 4 cycles at standard institutional dosing. This is the backbone chemotherapy regimen for both study arms, with the experimental arm receiving Naderin as an adjunct prophylactic agent | Drug | Chemotherapy alone Group |
Primary outcome
Incidence of leukopenia during chemotherapy
Time frame: Through chemotherapy completion, up to 4 months
Proportion of participants who develop leukopenia (white blood cell count below the institutional lower limit of normal) during any of the 4 chemotherapy cycles. Leukopenia is defined as a decrease in circulating white blood cells below 4.0 × 10⁹/L (or per institutional laboratory reference range)
5 secondary outcomes
Chemotherapy completion rate
Time frame: At the end of treatment, up to 4 months
Rate of chemotherapy interruption
Time frame: Through chemotherapy completion, up to 4 months
Requirement for colony-stimulating factors
Time frame: Through chemotherapy completion, up to 4 months
Quality of Life assessment
Time frame: Baseline and at end of treatment, up to 4 months
All-cause mortality
Time frame: Through study completion, up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naderin and AC Chemotherapy in people with Breast Cancer and Hematologic Disorder, run by MIPO Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of leukopenia during chemotherapy (time frame: Through chemotherapy completion, up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.