- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06313086
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
March 14, 2024 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
442
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Information Group officer
- Phone Number: 86-0311-69085587
- Email: ctr-contact@cspc.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DP303c
DP303c injection, 3.0 mg/kg, Q3W.
|
intravenous injection
|
Active Comparator: trastuzumab emtansine
trastuzumab emtansine,3.6
mg/kg, Q3W.
|
intravenous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to approximately 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) by investigator
Time Frame: Up to approximately 4 years
|
PFS is evaluated by investigator according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
|
Up to approximately 4 years
|
Overall Survival (OS)
Time Frame: Up to approximately 4 years
|
Overall Survival
|
Up to approximately 4 years
|
Objective response rate (ORR)
Time Frame: Up to approximately 4 years
|
ORR is evaluated by investigator and BIRC according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
|
Up to approximately 4 years
|
Duration of response (DoR)
Time Frame: Up to approximately 4 years
|
Duration of Response
|
Up to approximately 4 years
|
Incidence and severity of adverse events (AEs)
Time Frame: Up to approximately 4 years
|
Incidence and severity of adverse events
|
Up to approximately 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 14, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Immunoconjugates
- Immunotoxins
- Trastuzumab
- Maytansine
- Ado-Trastuzumab Emtansine
Other Study ID Numbers
- SYSA1501-009
- CTR20240245 (Registry Identifier: NMPA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruiting
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruiting
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingHER2-positive Advanced Solid TumorsChina
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingHER2-positive Advanced Breast Cancer