BCD-236 plus chemotherapy for relapsed or metastatic triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial testing the investigational agent BCD-236 in combination with standard chemotherapeutic agents for adults with relapsed or metastatic triple negative breast cancer. Eligible participants must have tumor AXL expression confirmed by immunohistochemistry and have received at least one prior line of systemic therapy; a fresh tumor sample is required for screening. The study will collect data on tumor response, safety and tolerability, pharmacokinetics, and immunogenicity while participants receive the combination regimen. Treatment and follow-up visits will occur at regional oncology centers in Belarus.

Why it matters

Who can join: the full rules

Main Inclusion Criteria:

* Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.
* Age ≥18 years and \<75 years at the time of signing the informed consent form.
* Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER \<1%, PR \<1% (ASCO/CAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.
* 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.
* Confirmed AXL expression in tumor cells according to immunohistochemistry.
* Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.
* Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria for CIR.
* ECOG score 0-1.
* Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.

Main Exclusion Criteria:

* Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
* Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions \>1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.

Where it's running

• Health Institution "Brest Regional Oncology Center"
  Brest, Belarus Recruiting
• "Gomel Regional Clinical Oncology Dispensary"
  Homyel, Belarus Recruiting
• Minsk City Oncology Center
  Minsk, Belarus Recruiting
• SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"
  Chelyabinsk, Russia Recruiting
• Budgetary healthcare institution of the Udmurt Republic "Republican clinical oncology dispensary named after Sergei Grigorievich Primushko of the Ministry of Health of the Udmurt Republic
  Izhevsk, Russia Recruiting
• SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"
  Kaluga, Russia Recruiting

Study contacts

• Study coordinator: Evgenia А Mikhailova
• Email: mikhailova@biocad.ru
• Phone: +7 911 081 23 68

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative Breast Cancer

  This study tests an AI model using pre-treatment breast MRI to see if it can identify which locally advanced triple-negative breast cancer patients will benefit most from neoadjuvant chemotherapy.

  Recruiting Fujian Cancer Hospital · Fuzhou, Fujian and 4 other locations · NCT07880600

• JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners

  This phase 2 study tests JS212 alone or with JS207 or JS001 to see if it helps people with recurrent or metastatic triple-negative breast cancer.

  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality and 30 other locations · NCT07876557

• Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

  This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.

  Recruiting at 2 sites Phase 1 Novartis · Darlinghurst, New South Wales and 1 other locations · NCT07801508

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Oral paclitaxel in triple-negative breast cancer before main chemotherapy

  This trial tests whether giving an oral paclitaxel dose-6 in combination with standard epirubicin and cyclophosphamide can be tolerated in women with triple-negative breast cancer before surgery.

  Recruiting Phase 1/2 The Affiliated Hospital Of Guizhou Medical University · Guiyang, Guizhou · NCT07739485

• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

  Recruiting Fudan University · Shanghai · NCT07705438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.