Printed from Voxsanity (voxsanity.com.au) — NCT07150208 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07150208
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 with a good general health and activity level, rated 0 or 1 on a standard performance scale (called the ECOG scale).
- People expected to live for more than 12 weeks.
- People who have been diagnosed through tissue testing with invasive breast cancer that has a low level of a protein called HER2 (specifically, test results showing HER2 IHC 1+, or HER2 IHC 2+ with a follow-up test called FISH or CISH coming back negative), confirmed by the pathology department at the participating research centre.
- People whose breast cancer has come back or spread to other parts of the body, or whose local recurrence has been assessed by the research team as not suitable for curative surgery.
- People who have at least one area of cancer that has not previously been treated with radiation therapy.
- People who have brain metastases (cancer that has spread to the brain) shown on MRI or CT, and who meet one of the following: the brain metastases have not yet been treated; or previously treated brain metastases that are either stable or growing, and either have been stable on imaging for at least 4 weeks, or new brain metastases have been found on a recent MRI or CT scan.
- People who have received no more than 2 rounds (lines) of chemotherapy since their cancer spread or returned.
- People whose breast cancer is hormone receptor (HR) positive must have previously been treated with a type of drug called a CDK4/6 inhibitor, either during earlier treatment or after the cancer spread.
- People who have never previously been treated with the drugs T-DXd or bevacizumab.
- People whose major organ functions are within acceptable ranges, including: haemoglobin at least 90g/L (without a blood transfusion in the past 14 days), white blood cell count (ANC) at least 1.5×10⁹/L, and platelet count at least 75×10⁹/L; and blood chemistry results within acceptable limits for liver and kidney function as defined by the trial (confirm with trial site).
- People who may be using mannitol or hormone therapy before joining, provided the dose has been stable for at least one week and does not need to be increased.
- Women who are able to become pregnant and agree to use a medically approved form of contraception throughout the study treatment and for at least 3 months after the last dose of the study drug.
- People who willingly choose to join the study, sign a consent form, are able to follow the study requirements, and are willing to attend follow-up appointments.
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 have already received more than 2 lines of chemotherapy after their cancer spread.
- People who have previously been treated with T-DXd or bevacizumab.
- People who have cancer that has spread to the lining of the brain or spinal cord (meningeal metastasis).
- People with brain metastases that need urgent treatment, or that require more than 3mg per day of dexamethasone (or an equivalent steroid medication) to manage symptoms.
- People with a significant history of heart problems, including heart failure, angina, a heart attack in the past 6 months, or serious abnormal heart rhythms.
- People who are still experiencing side effects rated above grade 1 from a previous cancer treatment (exceptions may apply for hair loss or other cases the researcher considers appropriate, which must be documented).
- People who are pregnant.
- People who have had another type of cancer in the past 5 years, unless it was a fully treated cervical carcinoma in situ, basal cell skin cancer, or squamous cell skin cancer.
- People who have difficulty swallowing, ongoing severe diarrhoea, or a bowel obstruction, which may affect the ability to take and absorb study medications.
- People with large fluid build-ups in body cavities (such as the chest or abdomen) that cannot be controlled by draining or other methods.
- People who have taken part in another clinical trial of an anti-cancer drug within 4 weeks before the first dose of the study drug.
- People with wounds that have not healed over a long period, or bone fractures that have not fully healed.
- People with an active hepatitis B or C infection, or hepatitis B virus levels (HBV DNA) at or above 500, or chronic hepatitis with abnormal liver function results.
- People with a known primary immune deficiency condition, or a confirmed positive HIV test.
- People with an active infection that requires intravenous antibiotics, antiviral drugs, or antifungal drugs.
- People who have a history of lung inflammation or scarring (ILD/pneumonitis) that required steroid treatment, are currently experiencing this condition, or where imaging during screening cannot rule out suspected ILD/pneumonitis.
- People with clinically significant lung problems within 3 months before joining the study, including conditions such as pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or pleural effusion (fluid around the lungs).
- People with any autoimmune, connective tissue, or inflammatory disease (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) that is known or suspected to involve the lungs.
- People who have had an entire lung surgically removed (total pneumonectomy).
- People with a history of serious allergic reactions, a known allergy to any component of the study drugs, or a known allergy to other monoclonal antibody treatments.
- People with a history of gastrointestinal bleeding in the past 6 months, or signs that suggest a significant risk of gastrointestinal bleeding, such as oesophageal varices likely to bleed, active ulcers, or stool test results showing blood at a certain level (confirm with trial site for specific thresholds).
- People who have had an abdominal fistula, a hole in the gastrointestinal tract (perforation), or an abscess inside the abdomen within 28 days before joining the study.
- People whose urine test shows a significant level of protein in the urine, or a 24-hour urine protein measurement above 1.0g.
- People with uncontrolled high blood pressure that remains above 140/90 mmHg even with blood pressure medication.
- People with substance use issues, or other medical or personal circumstances that the research team believes could interfere with their participation in the study or the reliability of study results.
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.
Contact this trial
Phone: 08664175590 Ext. 88807
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 September 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression Free Survival(PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.