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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07618390
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
- A signed consent form must be completed before joining.
- Participants must be female and aged 18 or older at the time of signing the consent form.
- Participants must be postmenopausal, meaning one of the following applies: aged 60 or older; OR under 60 with no menstrual periods for 12 or more months in a row (without the use of contraceptive pills, hormone replacement therapy, or certain hormone-blocking medications), confirmed by specific hormone blood test results; OR both ovaries surgically removed at least 14 days before starting treatment, with recovery to normal health.
- Women who are not postmenopausal (premenopausal or perimenopausal) must already be receiving ongoing hormone-suppressing injections (such as goserelin or leuprorelin), started at least 2 weeks before the first treatment, and continued throughout the study.
- A diagnosis of breast cancer (a specific type called adenocarcinoma) must be confirmed by laboratory testing of tissue or cell samples, and the cancer must be locally advanced or has spread to other parts of the body and cannot be cured by surgery or radiation.
- The breast cancer tumour must test positive for estrogen receptors and/or progesterone receptors (meaning at least 1% of tumour cells show a positive result on the most recent biopsy), following standard testing guidelines.
- The breast cancer must test negative for HER2 (a specific protein), based on standard testing guidelines applied to the most recent biopsy.
- A specific gene mutation test (PIK3CA) must have been performed on a blood or tumour tissue sample using approved laboratory methods, to determine eligibility for study grouping.
- The cancer must have progressed during or within 12 months of finishing a standard hormone-blocking treatment (aromatase inhibitor or tamoxifen) given after initial surgery; if a CDK4/6 inhibitor was also used after surgery, more than 12 months must have passed since completing that treatment before progression.
- There must be at least one measurable area of cancer visible on scans, as defined by standard imaging criteria; people with cancer only in the bones are not eligible, even if those areas can be measured.
- Women who could become pregnant must agree to use effective non-hormonal contraception (with a failure rate of less than 1% per year) or abstain from sex during treatment and for specified periods after treatment ends, and must not donate eggs during this time.
- Participants must have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- Life expectancy must be more than 6 months.
- Blood test results taken within 14 days before starting treatment must show the body's blood cells, organ function, and chemistry are within acceptable ranges, including adequate white blood cells, red blood cells, and platelets; normal blood sugar and related levels; acceptable liver, kidney, and clotting function — with some allowances made for people who have liver or bone involvement, or who are on blood-thinning medication (confirm specific values with trial site).
- Participants must be willing and able to follow all study procedures, as assessed by the study doctor.
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 diagnosed with a specific rare type of breast cancer called metaplastic breast carcinoma.
- People with any history of cancer spreading to the membranes surrounding the brain or spinal cord (sometimes called leptomeningeal disease or carcinomatous meningitis).
- People who have previously received any systemic (whole-body) treatment for breast cancer that has spread to other parts of the body.
- People who have previously been treated with fulvestrant or similar medicines that break down oestrogen receptors, except where such treatment was given before surgery for 6 months or less.
- People who have previously received any treatment targeting the PI3K, AKT, or mTOR pathways in the body.
- People who need chemotherapy at the time of joining the study (for example, due to a medical emergency involving rapid organ decline, as defined by local medical guidelines).
- People with type 1 diabetes at any point in their history, or type 2 diabetes that currently requires ongoing medication.
- People who are unable or unwilling to take tablets by mouth or receive injections into a muscle.
- People with a condition that prevents proper absorption of food or medication through the digestive system.
- People with brain or spinal metastases that are untreated or currently active (meaning the disease is progressing, or anti-seizure or steroid medications are needed to manage symptoms).
- People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once every two weeks.
- People who required intravenous (IV) antibiotics for a serious infection in the 7 days before enrolling.
- People with any active eye condition affecting the eye or the inside of the eye that would need treatment during the study to prevent or treat possible vision loss.
- People with an active inflammatory or infectious eye disease, or a history of uveitis caused by the immune system or of unknown origin.
- People who need supplemental oxygen every day.
- People with active and symptomatic lung disease, including pneumonia.
- People with active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or who are currently taking immunosuppressive medications for such conditions.
- People with any active inflammation of the intestines, including diverticulitis.
- People with high calcium levels in the blood that are causing symptoms and require ongoing treatment with bone-strengthening medications (bisphosphonates or denosumab).
- People with clinically significant active liver disease, including severe liver impairment, viral hepatitis, cirrhosis, or current alcohol misuse.
- People known to have HIV infection.
- People with any severe or uncontrolled illness affecting the heart, lungs, metabolism, or involving active infection, that could affect the safety of the study or make results difficult to interpret.
- People who have received any anti-cancer treatment within 2 weeks before the first study dose.
- People who have taken part in another drug trial within 4 weeks before the first study dose.
- People who have previously had radiation therapy covering 25% or more of their bone marrow, or who have had a stem cell or bone marrow transplant.
- People with unresolved side effects from previous treatments (except hair loss, hot flushes, or mild-to-moderate nerve-related symptoms).
- People diagnosed with another cancer in the past 5 years, with exceptions for certain low-risk cancers such as treated early-stage cervical cancer, common non-melanoma skin cancers, or early-stage uterine cancer.
- People with significant heart or cardiovascular conditions, including: a stroke or mini-stroke (TIA) in the past 6 months; a heart attack in the past 6 months; moderate-to-severe heart failure; uncontrolled or dangerous heart rhythm problems; significant narrowing of the heart's arteries or unstable chest pain; a prolonged heart electrical interval on ECG (QTc above 470 ms) or a personal history of certain inherited heart rhythm conditions; significant abnormalities seen on a heart tracing (ECG); evidence of a previous heart attack on ECG; or significantly abnormal levels of key minerals in the blood (such as potassium, magnesium, or calcium).
- People who regularly take corticosteroids (such as prednisone at 10 mg per day or more) or other immune-suppressing medications on an ongoing basis.
- People with a known allergy or hypersensitivity to inavolisib, ribociclib, fulvestrant, or any of their ingredients.
- People who have taken strong medications known to significantly interfere with how certain study drugs are processed by the body (strong CYP3A4 inhibitors or inducers) within 1 week or 5 half-lives of that medication before starting treatment, whichever is longer (confirm with trial site).
- People who are currently pregnant, breastfeeding, or planning to become pregnant during the study or within defined periods after treatment ends (7 days after inavolisib, 21 days after ribociclib, and up to 2 years after fulvestrant).
- People who have had major surgery or a significant physical injury within 28 days before starting treatment, or who are expected to need major surgery during the study.
- People who have had minor surgery within 7 days before the first dose without adequate recovery, including proper wound healing.
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: 15920589334
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 December 2028
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.