HLX22 plus trastuzumab deruxtecan for HER2-low, hormone receptor–positive advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, interventional trial gives eligible patients HLX22 (15 mg/kg) combined with trastuzumab deruxtecan (5.4 mg/kg) every three weeks. Participants have HER2-low, hormone receptor–positive locally advanced or metastatic breast cancer with measurable disease and prior progression or intolerance to standard care. Treatment continues until loss of clinical benefit, unacceptable toxicity, death, or withdrawal of consent. Key eligibility includes ECOG 0–1, expected survival ≥6 months, adequate organ function, and no prior HER2-targeted therapy or prior interstitial lung disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
3. 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
4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
5. ECOG PS: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function

Exclusion Criteria:

1. Patients with other malignant tumors within 3 years before the randomization
2. Previous treatment with any HER2-target therapy
3. Uncontrolled or significant cardiovascular disease or infection
4. Lung-specific intercurrent clinically significant illnesses
5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
6. Patients with spinal cord compression or clinically active central nervous system metastases

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yun Li
• Email: Shirley_Li@henlius.com
• Phone: +86-15800864157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.