HER2-positive Advanced Breast CancerPhase 3NCT05901935
DP303c in Patients With HER2-positive Advanced Breast Cancer
A Phase 3 study testing DP303c, Trastuzumab and Vinorelbine Tartrate in people with HER2-positive Advanced Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is a study of DP303c in patients with HER2-positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Advanced Breast Cancer
- What is being tested?
- DP303c, Trastuzumab and Vinorelbine Tartrate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the study and sign the informed consent;
- Age≥18 years old;
- Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology;
- Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- Received at least 2 lines of systemic therapy for unresectable locally advanced, recurrent, or metastatic diseases;
- Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
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- At least one assessable lesion at the baseline;
- The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Patients with adequate organ function;
- Life expectancy ≥ 12 weeks;
- Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period.
Who cannot join
- Pregnant or breastfeeding women;
- History of any other malignant tumors within three years
- Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0);
- The presence of active inflammatory bowel disease, chronic diarrhoea, short bowel syndrome or history of other gastrointestinal diseases or treatments that may affect intestinal absorption;
- Received systemic anti-tumor therapy within 28 days before randomization, traditional Chinese medicine treatment with tumor indications approved by the National Medical Administration (NMPA) and palliative radiotherapy within 2 weeks before randomization;
- Major organ surgery (excluding needle biopsy) within 28 days before randomization;
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- The cumulative amount of previous exposure to anthracyclines has reached the dosage;
- Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
- History of LVEF < 40%, symptomatic congestive heart failure (CHF),.
- Serious or uncontrolled cardiovascular disease;
- History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
- Patients who currently have corneal diseases that require medication or surgical intervention;
- Peripheral neuropathy ≥ grade 3 (refer to NCI CTCAE 5.0);
- Active infections requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before randomization;
- Active hepatitis B or C;
- History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive;
- Known hypersensitivity or contraindication to the active ingredients or excipients of the study drugs;
- Treated with strong CYP3A inhibitors or strong CYP3A inducers before randomization;
- There are other circumstances that may interfere with the subject's participation in the study procedures or do not meet the subject's maximum benefit from participating in the study or affect the study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
Read the detailed description
This is a multi-centre, randomized, open-label, controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab combined with vinorelbine/capecitabine in the treatment of HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab combined with vinorelbine/capecitabine every 3 weeks. Patients will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
- Conditions
- HER2-positive Advanced Breast Cancer
- Being tested
- DP303c, Trastuzumab, Vinorelbine Tartrate, Capecitabine tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP303cDrug
DP303c injection, 3.0 mg/kg, Q3W.
TrastuzumabDrug
IV, 6 mg/kg, D1, Q3W
Vinorelbine TartrateDrug
IV, 25 mg/m^2，D1、D8，Q3W
Capecitabine tabletsDrug
PO 1000 mg/m^2, bid, D1-D14, Q3W
| Study group | Role | What they receive |
|---|---|---|
| DP303c | Experimental | Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks. Receives: Drug: DP303c |
| Trastuzumab combined with vinorelbine/capecitabine | Active comparator | Eligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks. Receives: Drug: Trastuzumab; Drug: Vinorelbine Tartrate; Drug: Capecitabine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by BIRC
PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Measured: Up to approximately 5 years
Secondary outcomes (5)
Progression-free survival (PFS) by investigator
PFS is evaluated by investigator according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Measured: Up to approximately 5 years
Overall Survival (OS)
Overall Survival
Measured: Up to approximately 5 years
Objective response rate (ORR)
ORR is evaluated by investigator and BIRC according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Measured: Up to approximately 5 years
Duration of response (DoR)
Duration of Response
Measured: Up to approximately 5 years
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901935
- Sponsor's protocol ID
- SYSA1501-007
- Status last verified
- May 2023
- First submitted
- 4 Jun 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05901935
- Acronym / sponsor ID
- SYSA1501-007
- Conditions
- HER2-positive Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jun 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.
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
Detailed description
This is a multi-centre, randomized, open-label, controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab combined with vinorelbine/capecitabine in the treatment of HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab combined with vinorelbine/capecitabine every 3 weeks. Patients will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP303c | Experimental | Drug: DP303cEligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks. |
| Trastuzumab combined with vinorelbine/capecitabine | Active comparator | Drug: Trastuzumab, Drug: Vinorelbine Tartrate, Drug: Capecitabine tabletsEligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily agree to participate in the study and sign the informed consent;
- Age≥18 years old;
- Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology;
- Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- Received at least 2 lines of systemic therapy for unresectable locally advanced, recurrent, or metastatic diseases;
Key exclusion criteria (19 listed)
- Pregnant or breastfeeding women;
- History of any other malignant tumors within three years
- Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0);
- The presence of active inflammatory bowel disease, chronic diarrhoea, short bowel syndrome or history of other gastrointestinal diseases or treatments that may affect intestinal absorption;
- Received systemic anti-tumor therapy within 28 days before randomization, traditional Chinese medicine treatment with tumor indications approved by the National Medical Administration (NMPA) and palliative radiotherapy within 2 weeks before randomization;
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 |
|---|---|---|
| DP303cDP303c injection, 3.0 mg/kg, Q3W. | Drug | DP303c |
| TrastuzumabIV, 6 mg/kg, D1, Q3W | Drug | Trastuzumab combined with vinorelbine/capecitabine |
| Vinorelbine TartrateIV, 25 mg/m^2，D1、D8，Q3W | Drug | Trastuzumab combined with vinorelbine/capecitabine |
| Capecitabine tabletsPO 1000 mg/m^2, bid, D1-D14, Q3W | Drug | Trastuzumab combined with vinorelbine/capecitabine |
Primary outcome
Progression-free survival (PFS) by BIRC
Time frame: Up to approximately 5 years
PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
5 secondary outcomes
Progression-free survival (PFS) by investigator
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Objective response rate (ORR)
Time frame: Up to approximately 5 years
Duration of response (DoR)
Time frame: Up to approximately 5 years
Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 5 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 13 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DP303c, Trastuzumab and Vinorelbine Tartrate in people with HER2-positive Advanced Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 19 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: opening soon, as of the sponsor's last update on 13 Jun 2023. 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 phase mean?
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?
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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) by BIRC (time frame: Up to approximately 5 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 13 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.