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OncoMatch/Clinical Trials/NCT07342283

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

Is NCT07342283 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Immunotherapy combined with chemotherapy for triple negative breast cancer (tnbc).

Phase 2RecruitingAffiliated Hospital of Nantong UniversityNCT07342283Data as of May 2026

Treatment: Immunotherapy combined with chemotherapyThis is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 negative (Allred score <3 or <1% positive) (Allred score <3 or <1% positively stained cells)

ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components

Required: PR (PGR) negative (Allred score <3 or <1% positive) (Allred score <3 or <1% positively stained cells)

ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components

Required: HER2 (ERBB2) negative (0 or 1+ by FISH or IHC per NCCN guidelines) (0 or 1+ by FISH or IHC)

HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines

Disease stage

Required: Stage II, III

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months

Cannot have received: immunotherapy

Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months

Cannot have received: targeted therapy

Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months

Cannot have received: radiation therapy

Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months

Lab requirements

Blood counts

Kidney function

Liver function

Cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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