A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

Launched by SHANGHAI JMT-BIO INC. · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of two medications, KN026 and HB1801, together as a treatment for early or locally advanced HER2-positive breast cancer before surgery. The goal is to see if this combination is safe and effective in shrinking the cancer. The study will involve several medical centers and is designed to gather important information about how well these medications work together.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of HER2-positive breast cancer that is either early stage or locally advanced. They should also be in good overall health and agree to receive surgery at the end of the treatment period. Participants will need to commit to using effective birth control during the study and for a few months afterward. If you or someone you know meets these criteria and is considering joining, the trial will provide a chance to contribute to important research while receiving close medical support.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate in the experiment and sign the informed consent;
• • 2. Aged \>= 18 years;
• • 3. Histologically and cytologically confirmed primary invasive carcinoma of the breast with early (T2-3, N0-1, M0) or locally advanced stage (T2-3, N2-3, M0; T4, any N, M0) (AJCC 8th Edition);
• • 4. ECOG PS 0-1;
• • 5. HER2 positive (HER2+++ by IHC or HER2++ by IHC and ISH+);
• • 6. Agree to receive surgical treatment for breast cancer in the participating research unit when the surgical standard is reached after neoadjuvant therapy;
• • 7. Adequate organ and bone marrow function (no blood transfusions or hematopoietic stimulating factor classes within 14 days prior to the test);
• • 8. Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 3 months (Docetaxel and HB1801) or 7 months (Pertuzumab, trastuzumab, KN026, and Carboplatin) after the last dose of study drug;
• Exclusion Criteria:
• • 1. Inflammatory or bilateral breast cancer;
• • 2. History of non-breast malignancies within the 3 years prior to study entry, except for carcinoma in situ of the cervix or breast, and basal cell and squamous cell carcinomas of the skin, etc.;
• • 3. The researchers determine that there are contraindications for breast cancer surgery;
• • 4. Participants who underwent primary lumpectomy and/or axillary lymph node dissection biopsy prior to randomization (except for diagnostic biopsy of primary breast cancer or surgery for benign breast tumors);
• • 5. Any previous systemic chemotherapy, endocrine therapy or anti HER2 biological therapy or local radiotherapy for breast cancer;
• • 6. Sensitivity to any of the study medications or any of the ingredients or excipients of these medications;
• • 7. Participants with known allergies and/or contraindications to glucocorticoids;
• • 8. Have a congenital or acquired immune deficiency (such as HIV infection); 9 . Serious cardiac or cardiovascular disease or condition; 10 Serious chronic or active infections requiring intravenous antimicrobial, antifungal, or antiviral therapy were present within 14 days prior to randomization.
• • 11. Patients who had undergone major organ surgery (excluding biopsy) within 28 days before randomization and have not fully recovered.
• • 12. Potent inhibitors or inducers of CYP3A4 were used within 14 days before randomization or continued use was required.
• • 13. Being enrolled in other clinical trials (except for non-interventional clinical trials or a follow-up period in an interventional trial) or at randomization was less than 4 weeks from the end of the previous clinical trial (end of treatment).
• • 14. Pregnant or lactating. 15. The existence of other conditions that may interfere with the participant's study procedures or that do not correspond to the participant's maximum benefit from participating in the study or to the findings of the imaging study, such as a history of neurological or mental illness, alcohol abuse, drug use or substance abuse, any other disease or condition of clinical significance.