BridgeMD
New treatment option for Advanced Breast Cancer
Official title RC48-ADC in HER2-low Advanced Breast Cancer
ClinicalTrials.gov ID: NCT05831878
What this study is testing
What is Disitamab vedotin?
Disitamab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced breast cancer.
Also referred to as RC48-ADC.
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
- To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.
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, women only
You may be able to join if
- Female patients aged ≥18 years
- Expected survival ≥12 weeks
- ECOG 0-1
- Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
- At least one measurable lesion according to the RECIST 1.1
You likely can't join if
- History of thromboembolic events
- Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
- Active infections requiring systemic treatment
- Pregnant or lactating
- Presence of brain metastases and/or carcinomatous meningitis
See the full eligibility criteria
- Female patients aged ≥18 years
- Expected survival ≥12 weeks
- ECOG 0-1
- Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
- At least one measurable lesion according to the RECIST 1.1
- No history of antibody-drug conjugate use
- Up to one previous chemotherapy for advanced disease
- Available hormone receptor status. Hormone receptor-positive people are allowed to receive no more than two previous endocrine therapy for advanced disease
- HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \>0 but ≤10% of tumor cells
- Adequate organ function
- History of thromboembolic events
- Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
- Active infections requiring systemic treatment
- Pregnant or lactating
- Presence of brain metastases and/or carcinomatous meningitis
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.