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

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

NCT ID: NCT06519370

Condition: Triple Negative Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Gemcitabine
Capecitabine
Vinorelbine
Immunoconjugates

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: FDA018-ADC
Description: Subjects will receive FDA018-ADC 10 mg/kg of body weight via intravenous(IV) infusion on Day1 and 8 of a 21-day cycle in follow-up period until disease progression, unacceptable toxicity or death.
Arm group label: FDA018-ADC

Other name: FDA018-Antibody-drug Conjugate

Intervention type: Drug
Intervention name: Eribulin
Description: 1.4mg/m^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
Arm group label: Investigator's Choice of Chemotherapy (ICC)

Other name: Halaven

Intervention type: Drug
Intervention name: Capecitabine
Description: 1000 to 1250 mg/m^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest
Arm group label: Investigator's Choice of Chemotherapy (ICC)

Other name: Xeloda

Intervention type: Drug
Intervention name: Gemcitabine
Description: 800 to 1200 mg/m^2 will be administered IV on day 1 and Day 8 of each 21 day cycle
Arm group label: Investigator's Choice of Chemotherapy (ICC)

Other name: Gemzar

Intervention type: Drug
Intervention name: Vinorelbine
Description: 25 mg/m^2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle
Arm group label: Investigator's Choice of Chemotherapy (ICC)

Other name: Navelbine

Summary: This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent inoperable or metastatic Triple-negative Breast Cancer(TNBC) who are resistant to, or recurring during or after taxane therapy.

Detailed description: The primary objectives of the study are to demonstrate the superiority of FDA018-ADC relative to ICC by assessment of PFS per Blinded Independent Central Review(BICR) and OS in participants with locally recurrent inoperable or metastatic TNBC who are resistant to, or recurring during or after taxane therapy.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200000
Country: China

Status: Recruiting

Contact:
Last name: Jian Zhang, Doctor

Phone: 00-86-021-64175590
Email: Syner2000@163.com

Start date: August 9, 2024

Completion date: June 20, 2027

Lead sponsor:
Agency: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519370