AK112 plus nab‑paclitaxel versus placebo plus nab‑paclitaxel for first‑line inoperable or metastatic triple‑negative breast cancer

A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer

This trial tests whether adding AK112 to nab‑paclitaxel works better than placebo plus nab‑paclitaxel as first‑line treatment for adults with inoperable locally advanced or metastatic triple‑negative breast cancer.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (industry)
• Locations: 1 site (Beijing)
• Trial ID: NCT06767527 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double‑blind Phase 3 trial comparing AK112 combined with nab‑paclitaxel against placebo plus nab‑paclitaxel in patients with unresectable locally advanced or metastatic triple‑negative breast cancer who have not received prior systemic therapy for advanced disease. Participants must be 18–75 years old with ECOG performance status 0–1, at least one measurable lesion by RECIST v1.1, and adequate organ function. The study uses blinded assignment to active drug or placebo alongside standard chemotherapy and will monitor safety and anticancer efficacy outcomes. Treatment effect will be judged by tumor response and clinical outcomes while tracking adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed unresectable locally advanced or metastatic triple‑negative breast cancer, ECOG 0–1, no prior systemic treatment for advanced disease, at least one measurable lesion, and adequate organ function are the ideal candidates.

Not a fit: Patients who are eligible for curative surgery or radiotherapy for locally recurrent disease, have had another malignancy in the past 5 years, have active autoimmune disease requiring systemic therapy, are pregnant or breastfeeding, or have already received systemic therapy for advanced disease may not benefit from enrollment.

Why it matters

Potential benefit: If successful, adding AK112 to nab‑paclitaxel may shrink tumors more effectively and help patients live longer than chemotherapy alone.

How similar studies have performed: Other trials combining immunotherapy or targeted biologics with chemotherapy in triple‑negative breast cancer have shown benefit in some settings, but AK112 itself is a newer agent with limited large‑scale phase 3 results to date.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign a written informed consent form.
2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
7. Suitable for monotherapy with taxane-based agents.
8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
9. Adequate organ function.

Exclusion Criteria:

1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
2. History of other malignancies within the past 5 years.
3. Active autoimmune disease requiring systemic treatment within the past 2 years.
4. Pregnant or breastfeeding women.
5. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
7. Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
8. Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.

Where this trial is running

Beijing

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Xufang Yu

Conditions: Triple-Negative Breast Cancer