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OncoMatch/Clinical Trials/NCT06001086

A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer

Is NCT06001086 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Disitamb Vedotin ,pyrotinib for breast cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06001086Data as of Jun 2026Location: China

Treatment: Disitamb Vedotin ,pyrotinibEvaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Disitamb Vedotin ,pyrotinib

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) HER2 positive (evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines)

evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines

Allowed: ESR1 HR positive

tumors are either HR positive or HR negative (ER and PgR negative)

Allowed: PR (PGR) HR positive

tumors are either HR positive or HR negative (ER and PgR negative)

Allowed: ESR1 HR negative (ER negative)

tumors are either HR positive or HR negative (ER and PgR negative)

Allowed: PR (PGR) HR negative (PgR negative)

tumors are either HR positive or HR negative (ER and PgR negative)

Disease stage

Required: Stage II, III, IIIC (AJCC 8th edition)

Excluded: Stage IV

Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging system, 8th edition. Stage IV breast cancer according to AJCC staging system version 8 [excluded].

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Cannot have received: prior invasive breast cancer

Previous history of invasive breast cancer

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

Frequently asked questions

Is NCT06001086 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior prior invasive breast cancer disqualifies patients from enrollment.

Does this trial require ERBB2?

Yes, ERBB2 HER2 positive is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III or IIIC is required.

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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