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NCT07103447

PHASE2

Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

Sponsor: Shuangyue Liu

View on ClinicalTrials.gov

Summary

This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.

Official title: A Prospective, Multicenter, Single-Arm Study of AK112 in Combination With Albumin-Bound Paclitaxel and Carboplatin as Neoadjuvant Treatment for Triple-Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-10

Completion Date

2028-12-31

Last Updated

2025-08-05

Healthy Volunteers

Conditions

Breast Cancer - Female

Interventions

DRUG

AK112, Carboplatin, Paxlitaxel

The combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment.

Inclusion Criteria: 1. Voluntary Participation and Informed Consent: The participant voluntarily agrees to join this clinical trial, signs a written informed consent form, understands the study, and is willing to comply with all trial procedures. 2. Eligibility by Age and Gender: Female participants aged ≥18 years and ≤75 years on the day of signing the informed consent form. 3. Pathological Confirmation of Disease: Histopathologically confirmed diagnosis of T1-4N0-3M0 (except for T1N0M0) triple-negative invasive breast cancer, defined as negative for estrogen receptor (ER) and progesterone receptor (PgR) (immunohistochemistry: ER, PR \< 1%), and human epidermal growth factor receptor 2 (HER2) (immunohistochemistry HER2 "0\~1+"; or immunohistochemistry HER2 "2+" with no amplification on HER2 FISH gene testing). 4. Measurable Lesion: At least one lesion measurable according to RECIST v1.1 criteria. Participants diagnosed at an external institution agree to provide archived or freshly obtained tumor tissue samples (formalin-fixed paraffin-embedded \[FFPE\] tissue blocks or at least 25 unstained tumor tissue slides) for pathology review. 5. Planned Surgical Treatment: Participants are scheduled to undergo definitive surgical resection of breast cancer, including either breast-conserving surgery or mastectomy, along with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND), and are planned to receive neoadjuvant chemotherapy. Exclusion Criteria: 1. Prior Anti-Cancer Treatments. 2. Received systemic anti-cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (within 2 weeks for small molecule targeted therapies), or biological agent treatment within 4 weeks before enrollment. 3. Received palliative local treatments within 2 weeks before enrollment. 4. Received systemic non-specific immune modulatory treatments (e.g., interleukins, interferons, thymopeptides) within 2 weeks before enrollment. 5. Received traditional Chinese medicine or Chinese patent medicines with anti-cancer indications within 2 weeks before enrollment. 6. Prior PD-1/PD-L1 Treatment. 7. Previously received treatment with PD-1 inhibitors or PD-L1 inhibitors. 8. Concurrent Participation in Other Clinical Studies. 9. Currently participating in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study. 10. History of Other Malignancies: (1) Has a history of other malignant tumors within 5 years prior to enrollment or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and thyroid cancer. (2) Active Autoimmune Diseases: Has active autoimmune diseases that required systemic treatment (such as corticosteroids) within 2 years before enrollment, or has autoimmune diseases that the investigator judges may recur or require planned treatment.