HER2-positive Breast CancerPhase 3NCT06313086
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
A Phase 3 study testing DP303c and trastuzumab emtansine in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine 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 Breast Cancer
- What is being tested?
- DP303c and trastuzumab emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2024to Feb 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
- 1．Voluntarily agree to participate in the study and sign the informed consent;
- 2．Age≥18 years old;
- 3．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology;
- 4．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- 5．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease.
- 6．The Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
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- 7．Patients with adequate organ functions;
- 8．Life expectancy ≥ 3 months;
- 9．Female and male patients of childbearing age must agree to take adequate contraceptive measures during the entire study period.
Who cannot join
- 1. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy
- 2. History of any other malignant tumors within three years
- 3. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medical intervention.
- 4. Known contraindication to the study drugs;
- 5. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 or baseline (refer to NCI CTCAE 5.0);
- 6. NCI-CTCAE 5.0 ≥Grade 2 peripheral nephropathy occurred during previous systemic anti-tumor treatment;
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- 7. Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization .
- 8. Major organ surgery (excluding needle biopsy) within 28 days before randomization;
- 9. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
- 10.The cumulative amount of previous exposure to anthracyclines has reached the dosage;
- 11.History of LVEF < 40%, symptomatic congestive heart failure (CHF),
- 12.Serious or uncontrolled cardiovascular disease;
- 13.History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
- 14.Patients who currently have ocular diseases that require medication or surgical intervention; or unwilling to stop wearing contact lenses during the study.
- 15.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization;
- 16.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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, PhD, 021-64175590, xchu2009@hotmail.com
About this study
Official title: A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine 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 emtansine in in patients with HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab emtansine at 3.6 mg/kg 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 Breast Cancer
- Being tested
- DP303c, trastuzumab emtansine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP303cDrug
intravenous injection
trastuzumab emtansineDrug
Also called T -DM1
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| DP303c | Experimental | DP303c injection, 3.0 mg/kg, Q3W. Receives: Drug: DP303c |
| trastuzumab emtansine | Active comparator | trastuzumab emtansine,3.6 mg/kg, Q3W. Receives: Drug: trastuzumab emtansine |
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 4 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 4 years
Overall Survival (OS)
Overall Survival
Measured: Up to approximately 4 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 4 years
Duration of response (DoR)
Duration of Response
Measured: Up to approximately 4 years
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start13 Mar 2024
- Primary completionDec 2025 (estimated)
- Study completionFeb 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 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 442 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
- NCT06313086
- Sponsor's protocol ID
- SYSA1501-009
- Other IDs
- CTR20240245
- Status last verified
- Dec 2023
- First submitted
- 1 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. 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 DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06313086
- Acronym / sponsor ID
- SYSA1501-009
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Mar 2024 (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.
A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine 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 emtansine in in patients with HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab emtansine at 3.6 mg/kg 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
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| DP303c | Experimental | Drug: DP303cDP303c injection, 3.0 mg/kg, Q3W. |
| trastuzumab emtansine | Active comparator | Drug: trastuzumab emtansinetrastuzumab emtansine,3.6 mg/kg, Q3W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1．Voluntarily agree to participate in the study and sign the informed consent;
- 2．Age≥18 years old;
- 3．Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology;
- 4．Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- 5．Previously received regimens containing trastuzumab and taxanes at the advanced stage of disease.
Key exclusion criteria (16 listed)
- 1. Patients who have previously received tubulin inhibitor-loaded HER2 ADC therapy
- 2. History of any other malignant tumors within three years
- 3. With uncontrollable serous effusion within 14 days before randomization, which required frequent drainage or medical intervention.
- 4. Known contraindication to the study drugs;
- 5. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 or baseline (refer to NCI CTCAE 5.0);
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 |
|---|---|---|
| DP303cintravenous injection | Drug | DP303c |
| trastuzumab emtansineAlso: T -DM1intravenous injection | Drug | trastuzumab emtansine |
Primary outcome
Progression-free survival (PFS) by BIRC
Time frame: Up to approximately 4 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 4 years
Overall Survival (OS)
Time frame: Up to approximately 4 years
Objective response rate (ORR)
Time frame: Up to approximately 4 years
Duration of response (DoR)
Time frame: Up to approximately 4 years
Incidence and severity of adverse events (AEs)
Time frame: Up to approximately 4 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 10 May 2024.
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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?
A Phase 3 study testing DP303c and trastuzumab emtansine in people with HER2-positive Breast Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 9 inclusion and 16 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 10 May 2024. 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 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 4 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 10 May 2024.