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Trial Title:
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
NCT ID:
NCT06001086
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HER2-positive
RC48
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamb Vedotin ,pyrotinib
Description:
Disitamb Vedotin combined with pyrotinib
Arm group label:
Disitamb Vedotin combined with pyrotinib
Other name:
Regular Visits
Summary:
Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2
positive early breast cancer
Detailed description:
The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin
combined with pyrotinib in previously untreated histologically proven HER2 positive early
breast cancer and evaluate the PCR DFS,OS and safety of the subjects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1.18 to 75 years old (at the time of signing the informed consent form), regardless of
gender.
2. Subject type and disease characteristics. Histologically confirmed HER2 positive EBC
subjects:
1. evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
2. Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant
as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2
positive.
3. Multicenter tumors (multiple tumors involving more than one breast quadrant) must
sample one lesion from each affected quadrant and be confirmed as HER2 positive by
the central laboratory.
4. According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER
and PgR negative).
5. Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage
II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node
involvement is determined by fine needle aspiration or coarse needle aspiration
biopsy (if applicable).
3. When randomized, ECOG physical fitness status is 0 or 1 point.
Exclusion Criteria:
1. Previous history of invasive breast cancer.
2. Stage IV breast cancer according to AJCC staging system version 8.
3. Within 3 years, there is any primary malignant tumor, except for fully resected
non-melanoma skin cancer or cured in situ disease.
4. DCIS medical history, except for the subjects who only received Mastectomy
5. According to the judgment of the researchers, there is evidence of any diseases
(such as severe or uncontrolled systemic diseases, including persistent or
active infections, uncontrolled hypertension, kidney transplantation and active
bleeding diseases, and severe chronic gastrointestinal diseases related to
diarrhea) that the researchers consider to be unfavorable for the participants
to participate in the study or may affect adherence to the protocol.
6. Uncontrolled infection requiring intravenous administration of antibiotics,
Antiviral drug or antifungal drugs.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Li, Ph.D
Phone:
025-68307102
Email:
real.lw@163.com
Start date:
November 1, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001086
