BridgeMD
New treatment option for HER2-low Hormone Receptor Positive Breast Cancer
Official title A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
ClinicalTrials.gov ID: NCT06832202
What this study is testing
What is HLX22?
HLX22 is an investigational medicine, being studied as a potential treatment for her2-low hormone receptor positive breast cancer.
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
- This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
- Phase 2: a mid-size study of how well it works
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
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously...
- Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- ECOG PS: 0-1.
You likely can't join if
- Patients with other malignant tumors within 3 years before the randomization
- Previous treatment with any HER2-target therapy
- Uncontrolled or significant cardiovascular disease or infection
- Lung-specific intercurrent clinically significant illnesses
- Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
- Patients with spinal cord compression or clinically active central nervous system metastases
See the full eligibility criteria
- Male/female who are at least 18 years of age on the day of signing the informed consent.
- With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
- Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- ECOG PS: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
- Patients with other malignant tumors within 3 years before the randomization
- Previous treatment with any HER2-target therapy
- Uncontrolled or significant cardiovascular disease or infection
- Lung-specific intercurrent clinically significant illnesses
- Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
- Patients with spinal cord compression or clinically active central nervous system metastases
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, 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.