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

NCT07342283 | Recruiting Phase 2

• 1 other identifier: 2025-K223-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This 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.

Conditions

Triple Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rates

  pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

  Up to approximately 9 months

Secondary Outcomes (4)

• Objective response rate（ORR）

  Up to approximately 27-30 weeks

• 3y-EFS

  Up to approximately 3 years

• Overall survival (OS)

  Up to approximately 8 years

• Adverse events

  up to 18 months

Study Arms (1)

experimental group

EXPERIMENTAL

QL1706 plus carboplatin and albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 plus doxorubicin/epirubicin and cyclophosphamide (21-day cycles for 4 cycles)

Drug: Immunotherapy combined with chemotherapy

Interventions

Immunotherapy combined with chemotherapy DRUG

Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score \<3 or \<1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
• Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
• Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
• Treatment-naïve subjects;
• Age ≥18 years, both genders eligible;
• ECOG performance status 0-1;
• Adequate bone marrow, cardiac, and organ function;
• Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
• Ability to comprehend and provide written informed consent.

You may not qualify if:

• History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
• Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
• Stage IV metastatic breast cancer;
• Administration of a vaccine within 30 days before the first dose of the study treatment;
• Subjects with severe systemic diseases;
• Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
• Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
• Lactating women should discontinue breastfeeding during the study;
• Subjects with known allergies to the study drug or any of its excipients;
• Any other condition deemed inappropriate for participation in the study by the investigator.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Liu Fan

CONTACT

86+18912250939; lflove2009@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 15, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2028
• Last Updated: March 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)