Printed from Voxsanity (voxsanity.com.au) — NCT07426822 — 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, Recruiting
NCT07426822
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 are able to understand and agree to the study requirements by signing a consent form before any study procedures begin.
- People who are 18 years of age or older at the time of signing the consent form.
- Adult women (before or after menopause) and adult men may be eligible, with the following notes about women's menopausal status:
- Women who have not yet reached menopause (including those in the transition period) may be eligible if they are willing to use a hormone-suppressing injection called an LHRH agonist, started at least four weeks before the study begins and continued for the whole study.
- Women are considered post-menopausal if they are aged 60 or older; or if they are under 60 and have had no periods for at least 12 months after stopping all hormonal treatments, chemotherapy, or similar medications, with blood test results confirming post-menopausal hormone levels; or if they have had both ovaries surgically removed permanently.
- People whose breast cancer has spread to other parts of the body (metastatic) or has advanced locally to a stage where surgery to remove it completely is not possible, and where scans or tests show the cancer has come back or is getting worse.
- People with metastatic breast cancer who have a specific genetic change in one or more of the genes PIK3CA, AKT1, or PTEN, confirmed by testing of tumour tissue or a blood test.
- People whose cancer meets the criteria for treatment with capivasertib and fulvestrant as determined by the treating doctor.
- People with a general health status rated as 0 or 1 on a standard scale (meaning fully active or restricted in strenuous activity but able to do light work), with no worsening in the past two weeks, and with a life expectancy of at least 12 weeks.
- People with adequate blood counts, clotting, liver, and kidney function based on blood tests.
- People who are able to swallow and keep down tablets or capsules taken by mouth.
- People who are able to meet the following pregnancy and contraception requirements:
- People who could become pregnant must not currently be pregnant or breastfeeding, must have a negative pregnancy blood test within 72 hours before starting the study drug, and must agree to further pregnancy tests during the study if needed.
- People who could become pregnant must use at least one highly effective contraception method plus a barrier method during the study and for 1 year after the last dose of study drug.
- People who could become pregnant must not donate or freeze eggs for future use during the study or for 1 month after the last dose.
- People whose partner could become pregnant must ensure that partner uses a highly effective contraception method plus a barrier method during the study and for 16 weeks after the last dose, unless the participant has had a vasectomy.
- People with a partner who could become pregnant must not donate or freeze sperm during the study or for 4 months after the last dose.
- Highly effective contraception methods accepted by this trial include: combined hormonal contraception that stops ovulation (pill, vaginal ring, or patch); progestogen-only hormonal contraception that stops ovulation (pill, injection, or implant); an intrauterine device (IUD); an intrauterine hormone-releasing system; surgical blocking of both fallopian tubes; complete abstinence from sex (only if consistent with the person's lifestyle and the study duration); or a vasectomised partner who is the person's only sexual partner and whose vasectomy has been medically confirmed as successful.
- Barrier methods alone (such as male condoms, female condoms, cervical caps, diaphragms with spermicide, or contraceptive sponges with spermicide) are not considered sufficient on their own but may be used alongside a highly effective method for added protection.
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 whose cancer is so advanced that the treating doctor considers hormone-based therapy to be inappropriate — for example, if there is serious organ involvement that could be life-threatening in the near term.
- People who have had another type of cancer (other than breast cancer) within the five years before starting the study, with exceptions for certain early-stage or non-invasive cancers such as cervical carcinoma in situ, non-melanoma skin cancer, or Stage I endometrioid uterine cancer.
- People who still have significant side effects from previous cancer treatments at the time of starting the study, other than hair loss (confirm with trial site regarding grading details).
- People with known blood clotting disorders or who are taking blood-thinning medications that would prevent them from receiving injections into the muscle, such as the fulvestrant or LHRH injections used in this study.
- People who have recently received chemotherapy or other anti-cancer treatments not specified in the study protocol without a sufficient gap (washout period) before joining — for example, within three half-lives of a small-molecule anti-cancer drug, or within four weeks of an antibody-based anti-cancer treatment.
- People currently using herbal or natural products intended to treat or prevent any type of cancer.
- People who have had radiotherapy within two weeks before the first dose of the study treatment.
- People who have had major surgery (not including placement of a drip or port) or a serious injury within four weeks before the first dose, or who are expected to need major surgery during the study.
- People who have taken certain medications that strongly affect how the body processes the study drug capivasertib (known as strong CYP3A4 inhibitors or strong/moderate CYP3A4 inducers) within two weeks before starting capivasertib (or three weeks for St John's Wort) (confirm with trial site for full medication list).
- People taking any medications that may interfere with the safety or effectiveness of fulvestrant, cetirizine, or loperamide, based on prescribing guidelines.
- People with significant blood sugar problems, specifically: those with Type 1 or Type 2 diabetes who require insulin; or those with an HbA1c blood sugar level of 8.0% or higher.
- People with cancer that has spread to the spinal cord or brain, unless it has been treated, is stable, has no symptoms, and has not required steroid treatment within the four weeks before starting the study.
- People whose cancer has spread to the membranes surrounding the brain and spinal cord (leptomeningeal metastases).
- People whose blood test results show poor bone marrow or organ function, specifically if any of the following apply: white blood cell count (neutrophils) below a certain level; platelet count below a certain level; haemoglobin (red blood cell measure) below a certain level (with any recent blood transfusion having been given more than 14 days before the qualifying test); liver enzyme levels (ALT and AST) above certain thresholds depending on whether liver metastases are present; total bilirubin above a certain level (people with a confirmed condition called Gilbert's syndrome may still be eligible); or kidney function below a certain threshold (confirm specific values with trial site).
- People with severe or uncontrolled health conditions as judged by the treating doctor, including uncontrolled high blood pressure or active infections such as hepatitis B, hepatitis C, or HIV — although people with HIV that is well controlled on antiretroviral therapy (undetectable viral load) may still be eligible.
- People who have previously been treated with AKT inhibitors or PI3K inhibitors.
- People with a history of skin or bowel conditions that, in the treating doctor's opinion, would make the use of capivasertib unsafe.
- People with a history of allergic reactions to capivasertib, fulvestrant, LHRH agonists (if applicable), or to medications with a similar structure or belonging to the same drug class.
- People who have previously been unable to tolerate cetirizine or loperamide.
- People with ongoing severe nausea and vomiting, poor absorption of food or medications, chronic bowel conditions, inability to swallow study medications, a history of significant bowel removal surgery, or any other condition that would prevent proper absorption of capivasertib.
- People with a history of inflammatory lung disease, lung damage caused by drugs or radiation requiring steroid treatment, or any currently active lung inflammation of this type.
- People with dementia, significantly altered mental state, or a psychiatric condition that would prevent them from understanding or agreeing to the study requirements.
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
Principal Investigator: Maryam Lustberg, MD, Yale University
Phone: 773-369-6904
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
Recruiting
Phase
Phase 2
Sponsor
Maryam Lustberg
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 April 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0; Number of patients who experience grade 2 or greater rash as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Can't join this trial?
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.