QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT07782840
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab (QL1706) — DRUG
    Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles.
  • Aromatase Inhibitor (AI) — DRUG
    Participants will receive exemestane, anastrozole, or letrozole. The specific aromatase inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period.
  • CDK4/6 inhibitor — DRUG
    Participants will receive abemaciclib or ribociclib. The specific CDK4/6 inhibitor, dose, and administration schedule will be selected according to the applicable prescribing information or clinical guidelines and will be continued throughout the approximately 18-week neoadjuvant treatment period.
  • Ovarian function suppression — DRUG
    Premenopausal and perimenopausal participants will receive ovarian function suppression with goserelin, leuprorelin, or triptorelin. The specific agent, dose, and administration schedule will follow the applicable prescribing information or clinical guidelines.

Study Details

This study will evaluate whether adding QL1706 (iparomlimab and tuvonralimab) to neoadjuvant endocrine therapy improves tumor response in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer who have had a poor response to neoadjuvant chemotherapy. Approximately 40 participants whose tumors have decreased by less than 40% on magnetic resonance imaging after two cycles of neoadjuvant TAC chemotherapy will be randomly assigned in a 1:1 ratio to receive either an aromatase inhibitor plus a CDK4/6 inhibitor or the same treatment combined with QL1706. Premenopausal and perimenopausal participants will also receive ovarian function suppression. The main outcome is the objective response rate during the study treatment period. Pathological response, changes in Ki-67, treatment safety, and changes in the tumor immune microenvironment will also be evaluated.

Key Dates

First listed
Aug 24, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 Plus Endocrine Therapy
    Participants will receive an aromatase inhibitor plus a CDK4/6 inhibitor and QL1706. QL1706 will be administered intravenously at 5 mg/kg on Day 1 of each 3-week cycle for six cycles. The aromatase inhibitor and CDK4/6 inhibitor will be administered according to their respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression.
  • Active Comparator: Endocrine Therapy
    Participants will receive an aromatase inhibitor plus a CDK4/6 inhibitor according to the respective prescribing information or applicable clinical guidelines throughout the neoadjuvant treatment period. Premenopausal and perimenopausal participants will also receive ovarian function suppression.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From randomization through the preoperative assessment after six treatment cycles, approximately 18 weeks ]

Central Contacts

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