Printed from Voxsanity (voxsanity.com.au) — NCT07191717 — 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
NCT07191717
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 diagnosed with localized invasive breast cancer that is estrogen receptor positive (ER+, meaning at least 10% of cancer cells test positive) and HER2 negative, at any grade, and classified as stage I to III at the time of surgery (including those who received treatment before surgery).
- People whose cancer tissue has been confirmed to meet specific hormone receptor and HER2 testing standards by a certified laboratory, following established clinical guidelines.
- People who have had a detectable level of circulating tumor DNA (a marker found in the blood that can indicate cancer activity) in a certified laboratory within the past six months, with no signs of cancer returning based on clinical or imaging assessment.
- People who have enough stored tissue samples (either from an initial biopsy or from surgery) available for the study; if adequate tissue is not available, the principal investigator must approve participation before entry.
- People with no history of other cancers in the past five years, except for certain early or skin-based cancers (ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell skin cancer) that were diagnosed and treated within the past five years, and no concurrent cancer or other serious medical conditions as assessed by the investigator.
- People who may or may not have received chemotherapy and/or biological therapy before or after surgery, provided any ongoing side effects are mild (no worse than grade 1, except for nerve-related symptoms or hair loss up to grade 2).
- People who may or may not have received radiation therapy after surgery, provided any ongoing side effects are mild (no worse than grade 1).
- Women before or after menopause, and men, are eligible; women who could still become pregnant must have a negative blood pregnancy test at the time of screening (confirm with trial site for specific exemptions based on age, menstrual history, or surgical history).
- People aged 18 or older.
- People who have previously taken a CDK 4/6 inhibitor (a type of cancer medication), provided the last dose was taken more than six months before signing the consent form.
- People who are generally well and able to carry out daily activities, as measured by a standard health performance scale (ECOG 0–1, or Karnofsky score of 70% or higher).
- People who are currently taking hormone-blocking therapy (endocrine therapy) as part of their post-surgery treatment and have been taking it for a total of at least 24 months (cumulative).
- People who are able to understand the study and are willing to sign a written consent form before any screening takes place, and who are able to follow the study requirements.
- People currently receiving adjuvant endocrine therapy (tamoxifen or an aromatase inhibitor such as letrozole, anastrozole, or exemestane) for at least two years; pre- and peri-menopausal women and men taking an aromatase inhibitor must also be receiving a hormone-suppressing injection (GnRH agonist).
- People whose blood counts meet the required levels: sufficient white blood cells (neutrophils ≥ 1.5 × 10⁹/L), platelets (≥ 100 × 10⁹/L), and haemoglobin (≥ 9.0 g/dL) (confirm with trial site).
- People whose kidney function meets the required levels, based on blood test results (confirm with trial site).
- People whose liver function meets the required levels based on blood tests, including those with Gilbert's Syndrome if their bilirubin levels are within specified limits (confirm with trial site).
- People who are able to swallow oral (tablet or capsule) medications.
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 breast cancer has spread to other parts of the body (metastatic disease, including spread to lymph nodes on the opposite side) or who have inflammatory breast cancer (note: locally advanced breast cancer that caused inflammation without a diagnosis of inflammatory carcinoma does not automatically exclude a person — confirm with trial site).
- People who have received a CDK 4/6 inhibitor medication within the past six months.
- People who are currently taking any other experimental (investigational) cancer treatments; participation in observational studies is permitted.
- People who have had another cancer diagnosis within the past five years, except for ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, or basal cell or squamous cell skin cancer, or those with a concurrent cancer or other serious medical condition as assessed by the investigator.
- People who use herbal products or supplements, which are generally not permitted; specific supplements such as CBD oil may be considered on a case-by-case basis by the overall principal investigator.
- People with serious uncontrolled illnesses, including active infection, heart failure, lung disease, severe breathing difficulties, severe kidney impairment, unstable chest pain, heart rhythm problems, a pre-existing condition causing ongoing moderate-to-severe diarrhoea, or mental health or social circumstances that would make it difficult to follow the study requirements; also excluded are people with conditions affecting how the gut absorbs medications (such as active ulcers, uncontrolled nausea, vomiting, diarrhoea, malabsorption, or prior stomach or small bowel surgery), or people with active serious bacterial, fungal, or viral infections including known HIV (not on treatment), or active hepatitis B or C.
- People with a personal history of fainting due to a heart-related cause, dangerous heart rhythm problems (such as ventricular tachycardia or ventricular fibrillation), or sudden cardiac arrest.
- People with a history of blood clots in the veins (deep vein thrombosis or pulmonary embolism), except in cases of an uncomplicated blockage related to a venous catheter; also excluded are people with a personal history of fainting due to a heart-related cause, dangerous heart rhythm problems, or sudden cardiac arrest (confirm with trial site).
- People with a known allergy or sensitivity to imlunestrant, abemaciclib, or any ingredients in either medication.
- People living with HIV who are not on antiretroviral therapy; people with well-controlled HIV may be eligible (confirm with trial site).
- People who are pregnant, as the study medications may harm an unborn baby; women who could become pregnant and men must agree to use highly effective contraception during the study and for at least three months after treatment ends; if pregnancy occurs or is suspected during the study, the treating doctor must be informed immediately; acceptable contraception methods are specified in the trial protocol (confirm with trial site for full details).
- Women of childbearing potential, as defined in the trial protocol, who are not using highly effective contraception throughout the study and for 12 weeks after stopping the study medication; acceptable methods include total abstinence (if consistent with the person's lifestyle), surgical sterilisation, non-oestrogen hormonal contraception, an intrauterine device or system, or a GnRH agonist combined with one barrier method (confirm with trial site for full details).
- Women who are currently breastfeeding; breastfeeding should not occur during treatment or for one week after the last dose.
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: Marla Lipsyc-Sharf, UCLA / Jonsson Comprehensive Cancer Center
Phone: 3107944376
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
30 April 2026
Est. completion
30 April 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Rate of circulating tumor deoxyribonucleic acid (ctDNA) clearance
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.