Breast Cancereasy laughNCT05656079
To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study
A study testing Pegylated liposomal doxorubicin, Epirubicin and Cyclophosphamid in people with Breast Cancer, run by Shanghai Pudong Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer. 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?
- Pegylated liposomal doxorubicin, Epirubicin and Cyclophosphamid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Sep 2025
- Phase
- Interventional
- 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
- 18-70 years old, Female;
- Subjects with histopathologically confirmed invasive breast cancer;
- HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
- No distant metastasis;
- Lymph node positive or negative, primary tumour≥2cm;
- Lymph node negative，primary tumour≤2cm and any of the following factors; 1) Histological grade 3; 2) ER negative (<10%) and PR negative (<20%); 3) Age<35 years old; 4) Pathological hint: vascular invasion or intravascular cancer thrombus;
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- Surgery was completed and chemotherapy was started within 8 weeks after surgery;
- Before and after chemotherapy LVEF≥55%;
- ECOG performance status of 0-1;
- Signed the informed consent.
Who cannot join
- Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
- Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);
- For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
- Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;
- Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
- Active hypertension: systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 90mmHg;
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- NYHA cardiac insufficiency grading ≥ Ⅲ grade;
- Severe, uncontrollable systemic disease;
- Subjects who are pregnant or breastfeeding, or subjects who cannot ensure effective contraceptive measures during the study treatment;
- Subjects who participated in other clinical trials at the same time;
- Subjects determined by the investigator to be inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong Hospital
Shanghai
Yongping Li, liyongpingdt@sina.com
About this study
To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Pegylated liposomal doxorubicin, Epirubicin, Cyclophosphamid, Trastuzumab, Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated liposomal doxorubicinDrug
Also called duomeisu, Doxorubicin Hydrochloride Liposome Injection
Drug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle.
EpirubicinDrug
Also called biaoroubixing
Drug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
CyclophosphamidDrug
Also called huanlinxianan
Drug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
TrastuzumabDrug
Also called qutuozhudankang
Drug: Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
PertuzumabDrug
Also called patuozhudankang
Drug: Pertuzumab (840 mg loading dose at first day only, then 420 mg) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
DocetaxelDrug
Also called duoxitasai
Drug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel | Experimental | Pegylated liposomal doxorubicin 35 mg/m2, i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1 +Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1 ； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+ Pertuzumab 420 mg, i.v. d1+Trastuzumab 6 mg/kg, i.v. d1； q3w, for 4 cycles.
After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab. Receives: Drug: Pegylated liposomal doxorubicin; Drug: Cyclophosphamid; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel |
| Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab | Active comparator | Epirubicin 90 mg/m2 , i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1； q3w, for 4 cycles.
After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab. Receives: Drug: Epirubicin; Drug: Cyclophosphamid; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year incidence of cardiotoxicity
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jul 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656079
- Sponsor's protocol ID
- kazuma
- Acronym
- easy laugh
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05656079
- Acronym / sponsor ID
- easy laugh / kazuma
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 19 Dec 2022 (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.
To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel | Experimental | Drug: Pegylated liposomal doxorubicin, Drug: Cyclophosphamid, Drug: Trastuzumab, Drug: Pertuzumab, Drug: DocetaxelPegylated liposomal doxorubicin 35 mg/m2, i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1 +Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1 ； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+ Pertuzumab 420 mg, i.v. d1+Trastuzumab 6 mg/kg, i.v. d1； q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab. |
| Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamid, Drug: Trastuzumab, Drug: Pertuzumab, Drug: DocetaxelEpirubicin 90 mg/m2 , i.v. d1 +Cyclophosphamide 600 mg/m2 , i.v. d1； q3w, for 4 cycles followed by Docetaxel 75mg/m2 , i.v. d1+Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg), i.v. d1+Pertuzumab (840 mg loading dose at first day only, then 420 mg), i.v. d1； q3w, for 4 cycles. After the completion of adjuvant therapy, patients are required to receive a total of 1 year of treatment with trastuzumab combined with pertuzumab. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-70 years old, Female;
- Subjects with histopathologically confirmed invasive breast cancer;
- HER2-positive breast cancer (Immunohistochemistry score of 3+ or fluorescence in situ hybridization positivity);
- No distant metastasis;
- Lymph node positive or negative, primary tumour≥2cm;
Key exclusion criteria (11 listed)
- Subjects who are known to be allergic or intolerant to chemotherapy drugs or their excipients;
- Previously suffered from invasive breast cancer, and other malignant tumors within 5 years (excluding carcinoma in situ of the cervix, carcinoma in situ of the rectum, carcinoma in situ of melanoma, basal cell carcinoma of the skin, and squamous cell carcinoma);
- For breast cancer, have received any anti-tumor therapy before randomization (except surgical treatment before enrollment);
- Hematopoietic function, renal function and liver function meet one of the following conditions: 1) Neutrophil count ≤1.5×109/L; 2) Platelet count ≤ 50×109/L; 3) Hemoglobin ≤ 8.0g/dL; 4) Creatinine clearance rate ≤30ml/min; 5) AST and ALT ≥ 2.5 times the upper limit of normal in subjects without liver metastases; 6) Bilirubin ≥ 2 times the upper limit of normal; 7) APTT/PT≥1.5 times the upper limit of normal;
- Have a history of cardiovascular disease or associated with severe cardiovascular disease, lung disease;
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 |
|---|---|---|
| Pegylated liposomal doxorubicinAlso: duomeisu, Doxorubicin Hydrochloride Liposome InjectionDrug: Pegylated liposomal doxorubicin (35 mg/m2) will be administered by an intravenous infusion on day 1 of each21-day cycle. | Drug | pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel |
| EpirubicinAlso: biaoroubixingDrug: Epirubicin (90 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab |
| CyclophosphamidAlso: huanlinxiananDrug: Cyclophosphamide (600 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab, pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel |
| TrastuzumabAlso: qutuozhudankangDrug: Trastuzumab (8 mg/kg loading dose at first day only, then 6 mg/kg) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab, pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel |
| PertuzumabAlso: patuozhudankangDrug: Pertuzumab (840 mg loading dose at first day only, then 420 mg) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab, pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel |
| DocetaxelAlso: duoxitasaiDrug: Docetaxel (75mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle. | Drug | Epirubicin；cyclophosphamide f；docetaxel；trastuzumab；pertuzumab, pegylated liposomal doxorubicin；cyclophosphamide；trastuzumab；pertuzumab ；docetaxel |
Primary outcome
1-year incidence of cardiotoxicity
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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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 study testing Pegylated liposomal doxorubicin, Epirubicin and Cyclophosphamid in people with Breast Cancer, run by Shanghai Pudong 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 10 inclusion and 11 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 19 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongping Li (021 68035102, liyongpingdt@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year incidence of cardiotoxicity (time frame: 1-year). 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 19 Dec 2022.