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Compares treatment options for HER2-positive Breast Cancer
Official title DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06313086
What this study is testing
What is DP303c?
DP303c is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.