Breast CancerPhase 4NCT02903524
Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer
A Phase 4 study testing Doxorubicin Hydrochloride Liposome injection and cyclophosphamide and pirarubicin and cyclophosphamide in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Doxorubicin Hydrochloride Liposome injection and cyclophosphamide and pirarubicin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 4
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with age between 18 and 70 years.
- Newly diagnosed breast cancer, stages IIb-IIIc.
- KPS performance status≥70.
- Measurable disease according to RECIST version 1.1.
- Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
- Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
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- Adequate hepatic and renal function.
- AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
- Serum creatinine≥44 µmol/L and ≤133 µmol/L.
- Written informed consent are acquired.
- Not in pregnancy or the pregnancy tests of females is negative.
Who cannot join
- Severe heart failure (NYHA grade II or higher).
- Active and uncontrolled severe infection.
- Have accepted any other anti-tumor drug within 30 days before the first dose or
- received radiation treatment.
- Other situations that investigators consider as contra-indication for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050019
Geng Cuizhi, archiater, 0311-66696310, gengcuizhi@hotmail.com
About this study
Official title: The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients
- Conditions
- Breast Cancer
- Being tested
- Doxorubicin Hydrochloride Liposome injection and cyclophosphamide, pirarubicin and cyclophosphamide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxorubicin Hydrochloride Liposome injection and cyclophosphamideDrug
pirarubicin and cyclophosphamideDrug
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy Receives: Drug: pirarubicin and cyclophosphamide |
| Experimental group | Experimental | Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy Receives: Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response
Measured: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
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.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903524
- Sponsor's protocol ID
- CSPC-DMS-BC-03
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer ：a Randomised Multicentre, Open-label Trial
- ClinicalTrials.gov ID
- NCT02903524
- Acronym / sponsor ID
- CSPC-DMS-BC-03
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- 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.
Evaluate the efficacy and safety of Doxorubicin Hydrochloride Liposome Injection Plus Cyclophosphamide Compared to Pirarubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: pirarubicin and cyclophosphamidePirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy |
| Experimental group | Experimental | Drug: Doxorubicin Hydrochloride Liposome injection and cyclophosphamideDoxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female patients with age between 18 and 70 years.
- Newly diagnosed breast cancer, stages IIb-IIIc.
- KPS performance status≥70.
- Measurable disease according to RECIST version 1.1.
- Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
Key exclusion criteria (5 listed)
- Severe heart failure (NYHA grade II or higher).
- Active and uncontrolled severe infection.
- Have accepted any other anti-tumor drug within 30 days before the first dose or
- received radiation treatment.
- Other situations that investigators consider as contra-indication for this study.
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 |
|---|---|---|
| Doxorubicin Hydrochloride Liposome injection and cyclophosphamide | Drug | Experimental group |
| pirarubicin and cyclophosphamide | Drug | control group |
Primary outcome
pathological complete response
Time frame: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxorubicin Hydrochloride Liposome injection and cyclophosphamide and pirarubicin and cyclophosphamide in people with Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geng Cuizhi, archiater (0311-66696310, gengcuizhi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (time frame: until the completion of 4 cycles (each cycle is 21 days) of chemotherapy). 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 16 Sep 2016.