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New treatment option for Triple Negative Breast Cancer
Official title BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT07108309
What this study is testing
What is BCD-236?
BCD-236 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74, women only
You may be able to join if
- Main
- 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%...
- TNBC is progressive or relapsing on or after systemic therapy.
You likely can't join if
- Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
- Active CNS metastases and/or carcinomatous meningitis. people with brain metastases may participate in the study provided that the metastases have...
See the full eligibility criteria
- Main
- 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...
- 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...
- 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...
- 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
- Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
- Active CNS metastases and/or carcinomatous meningitis. people with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have...
The study team makes the final eligibility decision.
Where it's taking place
- Brest, Belarus
- Homyel, Belarus
- Minsk, Belarus
- Arkhangelsk, Russia
- Barnaul, Russia
- Chelyabinsk, Russia
- Izhevsk, Russia
- Kaluga, Russia
- Kazan', Russia
- Krasnodar, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Novosibirsk, Russia
- Obninsk, Russia
- Omsk, Russia
- Rostov-on-Don, Russia
- Ryazan, Russia
- Saint Petersburg, Russia
- Saransk, Russia
- Severodvinsk, Russia
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, Belarus; Homyel, Belarus; Minsk, Belarus; Arkhangelsk, Russia; Barnaul, Russia; Chelyabinsk, Russia and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.