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New treatment option for Breast Cancer
Official title A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
ClinicalTrials.gov ID: NCT06001086
What this study is testing
What is Disitamb Vedotin ,pyrotinib?
Disitamb Vedotin ,pyrotinib is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Regular Visits.
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
- Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer
- Phase 2: a mid-size study of how well it works
- 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
- 1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender. 2\. Subject type and disease characteristics...
- evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
- 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...
- Multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as...
- According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).
You likely can't join if
- Previous history of invasive breast cancer.
- Stage IV breast cancer according to AJCC staging system version 8.
- Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.
- DCIS medical history, except for the people who only received Mastectomy
- According to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including...
- Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.
See the full eligibility 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 people:
- evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
- 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.
- 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.
- According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).
- 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...
- Previous history of invasive breast cancer.
- Stage IV breast cancer according to AJCC staging system version 8.
- Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.
- DCIS medical history, except for the people who only received Mastectomy
- 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...
- Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 Nanjing, Jiangsu, 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.