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OncoMatch/Clinical Trials/NCT06767527

AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

Is NCT06767527 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including AK112 and Nab-paclitaxel for triple-negative breast cancer (tnbc).

Phase 3RecruitingAkesoNCT06767527Data as of Jun 2026Location: China

Treatment: AK112 · Nab-paclitaxelThis multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Nab-paclitaxel

Other

AK112

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 negative

negative status for ER

Required: PR (PGR) negative

negative status for PR

Required: HER2 (ERBB2) negative

negative status for HER-2

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

Adequate organ function

Kidney function

Adequate organ function

Liver function

Adequate organ function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06767527 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ESR1?

Yes, ESR1 negative is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR negative is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 negative is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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