QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

NCT06967103 | Recruiting Phase 2

• 1 other identifier: HELEN-024
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are: Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.

Conditions

Breast Cancer; HR+/HER2- Breast Cancer

Keywords

PD1; CTLA4; breast cancer

Outcome Measures

Primary Outcomes (2)

• pathological complete response

  After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

  up to 24 weeks

• pathological complete response in PDL1 positive subgroup

  After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

  up to 24 weeks

Secondary Outcomes (3)

• Event-Free Survival (EFS)

  5-10 years

• Objective Response Rate (ORR)

  up to 24 weeks

• adverse events

  up to 24 weeks

Study Arms (2)

QL1706 group

EXPERIMENTAL

NabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.

Drug: QL1706; Drug: Nab-PE

NabPE group

ACTIVE COMPARATOR

NabPEevery 3 weeks for 6 cycles. Then participants will receive surgery

Interventions

QL1706 DRUG

bispecific antibody targeting PD-1 and CLTA-4

QL1706 group

Nab-PE DRUG

Nab-paclitaxel+Epirubicin

QL1706 group

Eligibility Criteria

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

You may qualify if:

• Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.
• Female, aged ≥18 years .
• Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.
• cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \[ER\] or progesterone receptor \[PR\] nuclear staining \>1%) with Ki67 ≥20%.
• HER2-negative breast cancer, defined as:
• Negative in situ hybridization (ISH) results; or
• Immunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.
• Willing to provide fresh or archived tumor tissue samples.
• At least one measurable lesion per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate organ function, defined as:
• Hematology:
• Hemoglobin ≥90 g/L
• Absolute neutrophil count ≥1.5 × 10⁹/L

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from this study:
• Known severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.
• Stage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.
• Inflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).
• Major surgery or significant trauma within 28 days prior to the first dose.
• Administration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.
• Systemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.
• Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.
• Severe systemic infection within 28 days or active infection requiring intravenous/oral antibiotics within 14 days prior to the first dose.
• Prior organ or allogeneic bone marrow transplantation or awaiting transplantation.
• History or evidence of interstitial lung disease or active non-infectious pneumonitis.
• Bleeding tendency or high risk of hemorrhage.
• Thromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.
• Congenital or acquired immunodeficiency (e.g., HIV infection).
• Active hepatitis:

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenzhen Liu

CONTACT

13603862755; zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 13, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 30, 2029
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (1)