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OncoMatch/Clinical Trials/NCT07108309

BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer

Is NCT07108309 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including BCD-236 and Chemotherapy for triple negative breast cancer.

Phase 2RecruitingBiocadNCT07108309Data as of Jun 2026Location: Belarus · Russia

Treatment: BCD-236 · ChemotherapyTo study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and/or metastatic triple negative breast cancer (TNBC).

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Extracted eligibility criteria

Treatments studied

Other

BCD-236Chemotherapy

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: ESR1 expression 0-2 points or <1% (0-2 points or <1%)

ER 0-2 points, PR 0-2 points or ER <1%, PR <1% (ASCO/CAP)

Required: PR (PGR) expression 0-2 points or <1% (0-2 points or <1%)

ER 0-2 points, PR 0-2 points or ER <1%, PR <1% (ASCO/CAP)

Required: HER2 (ERBB2) expression ≤1+ or 2+ without amplification (≤1+ or 2+ without amplification)

HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH

Required: AXL expression (confirmed by immunohistochemistry)

Confirmed AXL expression in tumor cells according to immunohistochemistry

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 74
Female only

Prior therapy

Min 1 prior line

Must have received: systemic therapy — locally advanced unresectable or metastatic TNBC

TNBC is progressive or relapsing on or after systemic therapy. The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse / progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.

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

Frequently asked questions

Is NCT07108309 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic therapy.

Does this trial require ESR1?

Yes, ESR1 expression 0-2 points or <1% is a required biomarker for enrollment.

Does this trial require PGR?

Yes, PGR expression 0-2 points or <1% is a required biomarker for enrollment.

Does this trial require ERBB2?

Yes, ERBB2 expression ≤1+ or 2+ without amplification is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 74 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

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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