Phase 3 Breast Cancer Trial, Not Yet Recruiting NCT06434077 Sponsor: S.LAB (SOLOWAYS) Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Not Yet Recruiting

NCT06434077
Not Yet Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with metastatic breast cancer confirmed through tissue or cell testing.
  • People who have evidence of cancer that has spread, confirmed by imaging scans (such as CT, MRI, or PET) and/or biopsy.
  • People who have already completed at least one round of systemic treatment (such as chemotherapy, hormone therapy, or targeted therapy) for their metastatic breast cancer.
  • People for whom at least 4 weeks have passed since their last chemotherapy, targeted therapy, or radiotherapy before starting the study treatment.
  • Female patients between 18 and 70 years of age.
  • People with a performance status score of 0 to 2 on the ECOG scale, which generally means someone who is fully active or able to carry out light work (confirm with trial site).
  • People with an estimated life expectancy of at least 6 months.
  • People whose bone marrow is functioning adequately, as shown by specific blood count results meeting minimum levels for white blood cells, platelets, and haemoglobin (confirm with trial site for exact values).
  • People whose liver is functioning adequately, based on blood test results within acceptable ranges (confirm with trial site for exact values).
  • People whose kidneys are functioning adequately, based on blood test results within acceptable ranges (confirm with trial site for exact values).
  • Women who are able to become pregnant must agree to use effective contraception during the study and for at least 6 months after the last dose of the study treatment.
  • People who are able to understand and are willing to sign a written informed consent form.
  • People who are willing and able to follow the study schedule, including attending appointments, completing treatments, and undergoing lab tests.
  • People who have elevated levels of a substance called nagalase in their blood above the normal range, which can indicate active tumour activity.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who currently have another active cancer, other than certain treated skin cancers or early-stage cervical changes that have been adequately treated.
  • People with serious uncontrolled health conditions, such as significant heart disease (for example, uncontrolled high blood pressure or a recent heart attack), severe lung conditions (for example, uncontrolled asthma or chronic obstructive pulmonary disease), or active infections that require systemic treatment.
  • People who are pregnant or currently breastfeeding.
  • People who have previously received a treatment called GcMAF.
  • People who have a known allergy or sensitivity to any ingredient in the study drug or its formulation.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
S.LAB (SOLOWAYS)
Registry
ClinicalTrials.gov
Start date
20 August 2025
Est. completion
20 September 2026

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Change in Serum Nagalase Levels

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov