Breast CancerNCT05731258
Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
An observational study of Breast Cancer and Liposomal Doxorubicin, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Liposomal Doxorubicin, Efficacy
- What is being tested?
- Liposomal doxorubicin containing regimen
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer
Who may be able to join
- Female, aged 18-75 years;
- Primary breast cancer diagnosed histopathologically;
- Adjuvant chemotherapy regimens include liposomal doxorubicin;
- ECoG PS score: 0-1 points;
- Left ventricular ejection fraction (LVEF) ≥ 55%;
- Estimated survival ≥ 6 months;
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- Major organ function is normal, i.e. meets the following criteria:
- ① And white blood cells ≥ 4.0 × 10 9 / L, neutrophil count (ANC) ≥ 1.5 × 10 9 /L；② Platelets ≥ 100 × 10 9 /L；③ And hemoglobin ≥ 10 g / dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol / L and aspartate transaminase (AST) ≤ 2.5
- × ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；
- Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.
Who cannot join
- Pregnant, lactating patients;
- Breast cancer has been found to have distant metastasis;
- Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
- Those with severe infection or active peptic ulcer requiring treatment;
- Allergic to chemotherapy drugs;
- Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;
- Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;
- Patients who are participating in other clinical trials or within a month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliate Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Xiaochen Wang, Dr., +86 13958161286, wangxiaochen@zju.edu.cn
Shizhen Zhang, Dr., +86 15168338547, zhangshizhen@zju.edu.cn
About this study
Official title: Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.
- Being tested
- Liposomal doxorubicin containing regimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal doxorubicin containing regimenDrug
Liposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac safety
Cardiac ejection fraction
Measured: 10 years
Secondary outcomes (1)
Overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 May 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2032 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731258
- Sponsor's protocol ID
- 2022-0239
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen
- ClinicalTrials.gov ID
- NCT05731258
- Acronym / sponsor ID
- 2022-0239
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 16 Feb 2023 (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 observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early breast cancer patients who required four cycles of chemotherapy after curative resection of breast cancer
Key inclusion criteria (10 listed)
- Female, aged 18-75 years;
- Primary breast cancer diagnosed histopathologically;
- Adjuvant chemotherapy regimens include liposomal doxorubicin;
- ECoG PS score: 0-1 points;
- Left ventricular ejection fraction (LVEF) ≥ 55%;
Key exclusion criteria (8 listed)
- Pregnant, lactating patients;
- Breast cancer has been found to have distant metastasis;
- Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;
- Those with severe infection or active peptic ulcer requiring treatment;
- Allergic to chemotherapy drugs;
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 |
|---|---|---|
| Liposomal doxorubicin containing regimenLiposomal doxorubicin hydrochloride (PLD) 30-40mg/m2 D1 + other drugs (decided by investigators); All patients were treated with 4 cycles. | Drug | – |
Primary outcome
Cardiac safety
Time frame: 10 years
Cardiac ejection fraction
1 secondary outcome
Overall survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Liposomal Doxorubicin, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Feb 2023. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaochen Wang, Dr. (+86 13958161286, wangxiaochen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac safety (time frame: 10 years). 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 Feb 2023.