New combo aims to tackle Hard-to-Treat breast cancer
NCT ID NCT07446452
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of two drugs—disitamab vedotin and bevacizumab—in 37 people with HER2-low metastatic breast cancer whose disease progressed after prior T-DXd therapy. The goal is to see if the combo can shrink tumors and delay progression. Researchers will also study side effects and look for biomarkers that predict who benefits most.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- disitamab vedotin (a targeted drug) combined with bevacizumab (an anti-angiogenesis drug)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with HER2-low breast cancer whose disease has worsened after prior therapy.
- What could go wrong
- This is a small, early-phase trial (37 people) with no control group, so results may not be definitive. Side effects from the drug combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Jan 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Signed written informed consent prior to any study-related procedures. 2. Female or male participants aged 18 years or older. 3. Histologically or cytologically confirmed advanced or recurrent/metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-). 4. Received at least two cycles of trastuzumab deruxtecan (T-DXd) during treatment for recurrent or metastatic disease. 5. At least one measurable lesion according to RECIST version 1.1. A lesion within a previous radiation field may be considered measurable if disease progression is confirmed at that site. 6. ECOG performance status 0-2. 7. Expected survival time \>3 months. 8. Left ventricular ejection fraction (LVEF) ≥50% by ECHO or MUGA within 4 weeks prior to the first dose. 9. Adequate organ function as determined by laboratory assessments per investigator's judgment. Exclusion Criteria: 1. Uncontrolled comorbid conditions. 2. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks prior to enrollment. 3. History or current evidence of interstitial lung disease (ILD) or non-infectious pneumonitis. 4. Use of systemic immunosuppressive medications within 14 days prior to the first dose. 5. Clinically significant pulmonary comorbidities. 6. Allogeneic organ transplantation or hematopoietic stem cell transplantation (except corneal transplant). 7. Known hypersensitivity to bevacizumab, disitamab vedotin, or any of their components or excipients. 8. Spinal cord compression or clinically active central nervous system (CNS) metastases. 9. Unresolved toxicities or complications from prior therapy that have not recovered to baseline or ≤Grade 1 (per CTCAE v5.0). 10. Known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive). 11. Untreated active hepatitis B infection. 12. Active hepatitis C virus (HCV) infection. 13. Receipt of a live vaccine within 30 days before Cycle 1 Day 1. 14. Pregnant or breastfeeding women. 15. Any severe or uncontrolled systemic disease judged by the investigator to interfere with study participation or safety evaluation. 16. Gastrointestinal perforation or fistula, wound dehiscence requiring medical intervention, wound-healing complications, severe hemorrhage, arterial thrombotic events, or life-threatening (Grade 4) venous thromboembolism, including pulmonary embolism.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2 low breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The First Affiliated Hospital with Nanjing Medical University
RECRUITINGNanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a platform trial match the right drug combo to each tumor?
- Experimental HER2 cancer drug trial halted early
- New targeted pill takes aim at Hard-to-Treat cancers
- New hope for hard-to-treat breast cancer: phase 3 trial launches
- New drug shows promise for Hard-to-Treat breast cancers in Real-World study
- New scan could match breast cancer patients to best therapy