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Trial Title:
DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer
NCT ID:
NCT06313086
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Ado-Trastuzumab Emtansine
Maytansine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DP303c
Description:
intravenous injection
Arm group label:
DP303c
Intervention type:
Drug
Intervention name:
trastuzumab emtansine
Description:
intravenous injection
Arm group label:
trastuzumab emtansine
Other name:
T -DM1
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xichun Hu, PhD
Phone:
021-64175590
Email:
xchu2009@hotmail.com
Start date:
March 13, 2024
Completion date:
February 2028
Lead sponsor:
Agency:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Agency class:
Industry
Source:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313086