Combining Anlotinib and Trastuzumab Deruxtecan for Advanced HER2-Low 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 study evaluates the safety, tolerability, and efficacy of the combination of anlotinib and trastuzumab deruxtecan in patients with HER2-low unresectable or metastatic breast cancer who have previously received one line of chemotherapy. Participants will be monitored for their response to treatment and any adverse effects. The study aims to determine if this combination can provide a new treatment option for patients who have limited alternatives.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:

  1. Is unresectable or metastatic.
  2. Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).
  3. Is HR-positive or HR-negative.
  4. Has progressed on, and would no longer benefit from, endocrine therapy.
  5. Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting.

     3\. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）.

     4\. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.

     5\. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months.

     Exclusion Criteria:
     1. Has previously been treated with anti-angiogenic targeted small molecule therapy.
     2. Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative.
     3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
     4. Has unresolved toxicities from previous anticancer therapy.
     5. Has uncontrolled or significant cardiovascular disease.
     6. Has any bleeding event, unhealed wounds, ulcerative or fractures.
     7. Has arterial or venous thromboembolic events occurred within 6 months.
     8. Has spinal cord compression or clinically active central nervous system metastases.
     9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.

Where it's running

• Jian Zhang
  Shanghai, Shanghai Municipality, China Recruiting

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• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

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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.