Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer

NCT07246317 | Not Yet Recruiting Phase 2

• 1 other identifier: QL-BC-QIBA-1005
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 8

Brief Summary

This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.

Conditions

Breast Cancer

Keywords

QL1706; HER2+; breast cancer; neoadjuvant therapy; Pertuzumab; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

  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 16-18weeks

Secondary Outcomes (7)

• pCR rate using the definition of ypT0/Tis (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

  Up to approximately 16-18 weeks

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

  Up to approximately 12 weeks

• Event Free Survival

  Up to approximately 5 years

• Disease-free Survival

  Up to approximately 5 years

• Overall survival (OS)

  Up to approximately 5 years

Other Outcomes (1)

• AEs, TRAEs, SAEs

  Up to approximately 21-23 weeks

Study Arms (2)

QL1706 arm

EXPERIMENTAL

Trastuzumab, pertuzumab, docetaxel combined with QL1706, q3w, for a total of 4 cycles

Drug: QL1706 injection; Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar); Drug: Docetaxel

Standard therapy arm

ACTIVE COMPARATOR

Trastuzumab, pertuzumab, docetaxel combined with carboplatin, q3w, for a total of 4 cycles

Drug: Trastuzumab (or biosimilar); Drug: Pertuzumab (or biosimilar); Drug: Docetaxel; Drug: Carboplatin

Interventions

QL1706 injection DRUG

On Day 1 of each cycle at a dose of 5 mg/kg, IV infusion

QL1706 arm

Trastuzumab (or biosimilar) DRUG

On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks

QL1706 arm; Standard therapy arm

Pertuzumab (or biosimilar) DRUG

On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks

QL1706 arm; Standard therapy arm

Docetaxel DRUG

On Day 1 of each cycle at a dose of 75 mg/m², IV infusion

QL1706 arm; Standard therapy arm

Carboplatin DRUG

On Day 1 of each cycle at a dose of AUC = 4, IV infusion

Standard therapy arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent and compliant.
• Age 18-70 years.
• ECOG PS 0-1; life expectancy \>6 months.
• Histologically/cytologically confirmed primary breast cancer.
• Primary tumor \>2cm (by local standard assessment) or node-positive disease.
• AJCC 8th edition Stage II-IIIC (T2-T4 any N, or any T N1-3 M0) unilateral invasive breast cancer.
• Confirmed HER2-positive (IHC 3+ or ISH positive). Note: Patients with HER2-negative primary tumor but HER2-positive nodes are eligible.
• At least one measurable lesion per RECIST 1.1.
• Agreement to undergo surgery if indicated after neoadjuvant therapy.
• Willing to provide tumor tissue for biomarker analysis.
• Adequate organ function:
• ANC ≥1.5×10⁹/L; PLT ≥100×10⁹/L; HGB ≥90 g/L
• Albumin ≥30 g/L
• TBIL ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases); AKP ≤2.5×ULN
• Creatinine ≤1.5×ULN

You may not qualify if:

• Stage IV metastatic breast cancer or patients deemed ineligible for curative surgery after neoadjuvant therapy.
• Inflammatory breast cancer.
• Other malignancies within 3 years, except: those treated with surgery alone and disease-free for 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder cancer \[Ta, Tis, T1\].
• Prior anti-tumor therapy (chemotherapy, endocrine, anti-HER2) or breast surgery for breast cancer within 3 years (excluding diagnostic biopsy).
• Major surgery or significant traumatic injury within 28 days before treatment (excluding diagnostic biopsy).
• Active or history of autoimmune diseases (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Exceptions: vitiligo, childhood asthma in complete remission without intervention in adulthood.
• Current use of immunosuppressants or systemic corticosteroids (\>10mg/day prednisone equivalent) within 2 weeks prior to enrollment.
• History of severe hypersensitivity to monoclonal antibodies.
• Known central nervous system metastases.
• Poorly controlled concurrent illnesses, including:
• Uncontrolled hypertension (SBP\>150 or DBP\>100 mmHg on medication) or history of hypertensive crisis/encephalopathy.
• History of heart failure or systolic dysfunction (LVEF \<55%).
• Myocardial ischemia/infarction (≥Grade 2), arrhythmias (QTc≥450ms M, ≥470ms F), or CHF (≥NYHA Class II).
• Angina requiring medication; clinically significant valvular disease.
• Active HCV (RNA+), HIV+, syphilis (unless cured), or HBV (HBsAg+ with HBV DNA≥2000 IU/ml or positive qualitative test).

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (8)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University (FAH-SYSU)

Guangzhou, Guangdong, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

The West China Second University Hospital of Sichuan University (WCSUH- SCU)

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Biosimilar Pharmaceuticals; pertuzumab; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Jin Zhang

CONTACT

+8618622221173; zhangjintjmuch1@163.com

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)