FDA018-ADC Vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

Launched by SHANGHAI FUDAN-ZHANGJIANG BIO-PHARMACEUTICAL CO., LTD. · Jul 24, 2024

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ClinConnect Summary

This clinical trial is comparing a new treatment called FDA018-ADC with standard chemotherapy options for patients with a specific type of breast cancer known as triple-negative breast cancer (TNBC). This type of cancer does not respond to certain hormones and is often more challenging to treat. The study is looking for patients who have experienced a recurrence of their cancer after receiving a taxane-based treatment and who have advanced stages of the disease.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of TNBC, and have measurable cancer lesions, meaning the cancer can be assessed by doctors. Patients should also be able to provide written consent and have a good performance status, indicating they are well enough to participate. Those who join the study can expect to receive either the new treatment or one of the standard chemotherapy options, and they will be monitored closely for any effects of the treatment. It's important for potential participants to know that they must not have certain medical conditions or have received specific treatments recently to be included in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients capable to give written informed consent;
• • 2. Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization;
• • 3. Prior exposure to a taxane in localized or advanced/metastatic setting, and recurred during or after treatment;
• • 4. Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment;
• • 5. Have measurable lesions defined in RECIST v.1.1, those with only skin or bone lesions cannot be included;
• • 6. Expected survival≥3 months;
• • 7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
• • 8. Adequate bone marrow, hepatic, and renal function;
• • 9. All acute toxicity of previous anti-tumor treatment or surgery is relieved to baseline severity or NCI CTCAE version 5.0≤1;
• • 10. Subjects could provide tumor tissues or tissue specimens;
• • 11. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.
• Exclusion Criteria:
• • 1. Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
• • 2. Have central nervous system metastasis with clinical symptoms;
• • 3. Have history of clinical significant active chronic obstructive pulmonary disease, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose;
• • 4. Suffering from active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease), and history of intestinal obstruction, or Gl perforation;
• • 5. Patients with Gilbert's disease or heterozygous for the UGT1A1\*28 allele;
• • 6. Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive;
• • 7. Patients who have received prior TROP-2-targeted therapy;
• • 8. Patients who have received prior topoisomerase I inhibitor contained therapy;
• • 9. Received other anti-tumor treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, experimental treatment and so on) within 4 weeks prior to the first dose;
• • 10. Patients who have received live vaccines within 4 weeks prior to the first dose;
• • 11. Patients who had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
• • 12. Patients who had undergone systemic high-dose steroids within 2 weeks prior to the first dose;
• • 13. Patients have history of psychotropic drug abuse, alcohol or drug abuse;
• • 14. Women who are pregnant or lactating;
• • 15. Other circumstances that is deemed not appropriate for the study by investigator.