Clinical trial NCT06819319: SHR-A2102 Combined with Adebrelimab As Neoadjuvant Therapy for Early Triple-Negative Breast Cancer
Official title: A Phase II Study of SHR-A2102 in Combination with Adebrelimab As Neoadjuvant Therapy for Early Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: TNBC - Triple-Negative Breast Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label, multicenter Phase II study evaluating the efficacy and safety of of SHR-A2102 in combination with Adebrelimab in Early Triple-Negative Breast Cancer(TNBC)

Detailed description: This study plans to enroll patients with early-stage TNBC. The patients will first receive 8 cycles of neoadjuvant therapy, with imaging examinations conducted every 2 cycles to evaluate the treatment response. Subjects who complete the 8 cycles and are suitable for surgery will undergo surgical treatment after the completion of neoadjuvant therapy. The postoperative adjuvant therapy will last for one year. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged ≥ 18 years;
2. Histopathologically confirmed triple-negative invasive breast cancer, with no previous systemic anti-cancer treatment specifically for breast cancer;
3. At least one measurable target lesion according to RECIST V1.1;
4. ECOG performance status score of 0 to 1;
5. Life expectancy ≥12 weeks;
6. Adequate bone marrow reserve and organ system function reserve;
7. Participants should be able and willing to comply with the study protocol requirement;

Exclusion Criteria:

1. Breast cancer not histologically confirmed;
2. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
3. Previous treatment with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anti-PD-L2 drugs, or other immunotherapy;
4. Concurrent receipt of any other form of anti-cancer therapy;
5. History of a second primary malignancy, except for adequately treated skin cancer;
6. Participation in other drug clinical trials within 4 weeks before enrollment;
7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
8. Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
9. Uncontrolled or significant cardiovascular and cerebrovascular diseases;
10. Subjects with known or suspected interstitial pneumonia;
11. Presence of active hepatitis B, hepatitis C, liver cirrhosis; or severe infections requiring antibiotic, antiviral, or antifungal drug control;
12. Known inherited or acquired bleeding and thrombotic tendencies;
13. Known allergy or contraindication to the study drug and its excipients;
14. Pregnant or lactating female patients;
15. History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.

Primary outcomes:
measure: PCR rate
timeFrame: At the time of surgery
Secondary outcomes:
measure: EFS
timeFrame: 3-10 years
measure: DFS
timeFrame: 5-10 years
measure: DDFS
timeFrame: 5-10 years
Other outcomes:
Locations:
Study officials:
References: