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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07441512
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 signed a consent form agreeing to take part in the study.
- Female patients who are 18 years of age or older on the day they sign the consent form.
- People whose cancer can be measured or assessed using standard imaging criteria.
- People who are generally able to carry out daily activities with little or no restriction (a doctor will assess this using a standard scale scored 0 or 1).
- People whose doctors expect them to live for more than 12 weeks.
- People whose blood counts and organ function meet certain minimum levels when tested within 14 days before starting the study treatment, including: a sufficient level of infection-fighting white blood cells; sufficient red blood cell levels; sufficient platelet levels; blood sugar and long-term blood sugar control within normal ranges; liver function markers within acceptable ranges (with slightly higher limits allowed for people with known liver spread of cancer or bone spread); blood clotting tests within acceptable ranges (with specific adjustments allowed for people on blood-thinning medications such as warfarin); adequate protein levels in the blood; and kidney function meeting a minimum threshold based on a standard calculation.
- People with a controlled hepatitis B virus (HBV) infection, provided their liver function is normal, their virus levels are low, and they are receiving antiviral treatment under the care of a specialist doctor, and where the study doctor believes the benefits of joining outweigh the risks.
- People who test negative for hepatitis C antibodies, or who test positive for hepatitis C antibodies but negative for active hepatitis C virus, at the time of screening.
- People who have been diagnosed with a specific type of breast cancer (adenocarcinoma) that has spread locally or to other parts of the body, and cannot be removed by surgery or treated with radiation therapy with the aim of cure.
- People whose tumour has been confirmed to be hormone receptor-negative (meaning fewer than 1% of tumour cells show signs of responding to oestrogen or progesterone), based on the most recent local test results.
- People whose tumour has been confirmed to be HER2-negative based on specific laboratory testing, according to the most recent local assessment.
- People whose cancer has continued to grow or spread after at least one prior systemic treatment (such as chemotherapy or a type of targeted therapy called an antibody-drug conjugate, with or without an immunotherapy drug) for advanced disease.
- People who agree to provide a tumour tissue sample (preferably a fresh sample, but an archived sample may be acceptable) and a blood sample before starting treatment.
- People whose tumour tissue, when tested at a central laboratory, shows a specific change in a gene called PIK3CA that is on the study's approved list of eligible mutations (71 specific mutations are listed).
- Women who could potentially become pregnant and who agree to use highly effective non-hormonal contraception (along with a male condom with spermicide for male partners, unless the male partner has had a confirmed sterilisation procedure) or remain completely abstinent from heterosexual intercourse, throughout the treatment period and for at least 60 days after the last dose of one study drug (inavolisib) and at least 3 months after the last dose of the other study drug (eribulin); and who agree not to donate eggs during this time.
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 are pregnant, breastfeeding, or planning to become pregnant during the study. Women who could potentially become pregnant must have a negative pregnancy test within 14 days before starting study treatment.
- People who have a type of breast cancer called metaplastic breast cancer.
- People who have had radiation therapy within 4 weeks before the study start date.
- People who have Type 1 diabetes (any history), or Type 2 diabetes that currently requires ongoing medication.
- People who have a condition that prevents their body from properly absorbing food or medication through the digestive system.
- People who are unable or unwilling to swallow tablets or pills.
- People who have any history of cancer spreading to the lining around the brain or spinal cord (leptomeningeal disease or carcinomatous meningitis).
- People who have known and untreated, or currently active, cancer spread to the brain or spinal cord (central nervous system metastases). People who have had brain or spinal cord metastases that were previously treated may still be considered, provided they meet all of the following: they have measurable disease outside the brain or spine; they no longer need steroid medications for brain or spine symptoms and have been off steroids for at least 2 weeks; imaging showed improvement after treatment for the brain or spine cancer and there has been no sign of new growth since then; the most recent brain or spine scan was taken at least 4 weeks after completing radiotherapy; and they have no history of bleeding in the brain or spine.
- People who have a fluid build-up around the lungs, heart, or in the abdomen that needs to be drained every 14 days or more frequently. (An indwelling drainage catheter may be considered if the person has recovered adequately from the procedure and is stable, confirm with trial site.)
- People with high calcium levels in the blood that require ongoing treatment with specific bone-strengthening medications (bisphosphonates or denosumab). (Use of these medications for bone metastases or bone thinning is permitted.)
- People who have an active infection that the study doctor considers a risk to their safety, or who have had a serious infection requiring intravenous antibiotics within 7 days before the study start date.
- People who have active inflammation or infection affecting the eyes, or a history of a specific immune-related eye condition called idiopathic or autoimmune uveitis in either eye.
- People who require supplemental oxygen every day.
- People who have active lung disease causing symptoms (not related to their breast cancer), including lung inflammation (pneumonitis).
- People who have active tuberculosis.
- People who have a history of or currently active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or any active bowel inflammation including diverticulitis. People currently taking immunosuppressant medications for these conditions are considered to have active disease.
- People who have any serious medical condition or abnormal test results that the study doctor believes would make participation unsafe.
- People who have previously had a bone marrow or stem cell transplant, or radiation therapy covering more than 30% of their bone marrow.
- People who still have side effects from previous cancer treatment that are rated above a mild level (Grade 1), with the exception of hot flashes and hair loss (which may be any level), and nerve-related symptoms in the hands or feet (which may be up to Grade 1).
- People who have had a major injury or significant surgical procedure within 4 weeks before starting the study treatment, or who have surgery planned during the study period.
- People who test positive for HIV at screening.
- People who have significant liver disease, including severely reduced liver function (classified as Child-Pugh Class B or C), active viral or other hepatitis, current alcohol misuse, or cirrhosis. This includes people with active hepatitis B infection defined by specific blood test results showing high virus levels or abnormal liver function.
- People who have had another cancer in the past 5 years, except for: the breast cancer being studied; or certain low-risk cancers that have been adequately treated (such as early-stage cervical changes, certain skin cancers, localised prostate cancer, early-stage breast duct changes, or Stage I uterine cancer).
- People who have a history of, or currently have, an abnormal heart tracing (ECG) that is considered clinically significant (such as certain types of electrical conduction problems in the heart), or evidence of a previous heart attack on their ECG.
- People who have a history of, or currently have, significant heart or blood vessel problems, including: a stroke or mini-stroke (TIA) within 6 months before starting the study; a heart attack within 6 months before starting; moderate to severe heart failure requiring medication; uncontrolled abnormal heart rhythms or a history of serious heart rhythm problems requiring medication; symptomatic or unstable coronary artery disease; or certain inherited or acquired conditions affecting the heart's electrical timing (including specific QT interval abnormalities identified on ECG).
- People who have a known allergy or hypersensitivity to any of the study drugs or their ingredients.
- People who have previously been treated with a type of drug called a PARP inhibitor for advanced triple-negative breast cancer.
- People whose advanced triple-negative breast cancer progressed only on hormone therapy or HER2-targeted therapy, without ever having received chemotherapy for their advanced disease.
- People who have received any investigational (experimental) treatment within 28 days before starting the study treatment.
- People who have previously been treated with drugs that target the PI3K, AKT, or mTOR pathways, or who have previously been treated with eribulin (one of the study drugs).
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: 86+15958192550
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
Hu Hai
Registry
ClinicalTrials.gov
Start date
15 March 2026
Est. completion
15 March 2028
Primary endpoints
ORR by Investigator assessment per RECIST 1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 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.