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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07428018
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
- Women aged 18 years or older.
- People who have been diagnosed with invasive breast cancer, confirmed through a tissue biopsy.
- People whose breast cancer tumor tests positive for estrogen receptors (meaning at least 10% of tumor cells show estrogen receptor activity), measured using standard guidelines; any level of progesterone receptor expression is acceptable.
- People whose tumor has tested negative for HER2 (a specific protein), assessed according to standard guidelines by a local laboratory.
- People whose breast cancer is classified as Stage II to Stage IIIB (meaning it has not spread to distant parts of the body, with a limited exception for cancer found in certain nearby lymph nodes during a specific procedure).
- People whose medical team (a multidisciplinary tumor board) has recommended chemotherapy given before surgery (called neoadjuvant chemotherapy).
- People who are not currently considered suitable for breast-conserving surgery upfront but may become eligible if the tumor shrinks with treatment, and/or people who are not suitable for a specific type of lymph node removal procedure because cancer has been found in nearby lymph nodes.
- People who are in generally good physical condition, able to carry out everyday activities with no more than mild limitations (rated 0 or 1 on a standard medical scale).
- People who are able to swallow tablets or capsules.
- People whose blood counts are within an acceptable range: enough white blood cells, platelets, and red blood cells (a blood transfusion may be given beforehand if needed, but treatment cannot start until the day after any transfusion).
- People whose kidneys are functioning within an acceptable range, based on a blood test or a standard calculation.
- People whose liver is functioning within an acceptable range, based on standard blood tests; people with a condition called Gilbert's syndrome may still be eligible if their results meet certain levels (confirm with trial site).
- Women who could potentially become pregnant must have a negative pregnancy test taken within two weeks (preferably within seven days) before joining the trial, and must agree to use non-hormonal contraception (such as condoms, a diaphragm, or complete abstinence) from that point until surgery; hormonal contraceptives (pill, injection, implant) and hormone-releasing IUDs are not permitted during the trial.
- People who are willing to have breast surgery after completing pre-surgery treatment, and who agree to provide blood and tissue samples for the study, including a sample for a specific tumour analysis test called Oncotype Dx.
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 has spread to distant parts of the body (Stage IV) or who have Stage IIIC disease.
- People with inflammatory breast cancer or locally advanced breast cancer that cannot be operated on.
- People who have previously had invasive breast cancer in the same breast.
- People who have had or currently have another invasive cancer — with some exceptions for people whose prior or current cancer has been adequately treated, including: certain skin cancers (basal cell or squamous cell); melanoma that has not spread beyond the skin surface; non-breast cancer that has not spread beyond where it started; non-invasive breast cancer in either breast; a non-breast invasive cancer diagnosed at least five years ago with no recurrence; Stage I papillary thyroid cancer; Stage Ia cervical cancer; Stage Ia or Ib endometrial cancer; or borderline or Stage I ovarian cancer.
- People with a known history of serious heart or cardiovascular conditions, including uncontrolled chest pain (angina), very high blood pressure (180/110 mmHg or above), uncontrolled diabetes, breathlessness at rest, dependence on supplemental oxygen, severe heart failure, fainting due to heart problems, dangerous heart rhythm problems, or sudden cardiac arrest.
- People who are pregnant or currently breastfeeding (breastfeeding must have stopped before joining the trial).
- People with serious ongoing medical conditions that the trial doctor believes would make participation unsafe — examples include certain lung conditions, severe breathing difficulties, severely reduced kidney function, a history of major removal of part of the stomach or small bowel, Crohn's disease, ulcerative colitis, or any ongoing condition causing persistent moderate-to-severe diarrhoea.
- People who have had major surgery within 14 days before joining the trial.
- People who have received an experimental treatment in another clinical trial within the past 30 days (or longer, depending on the medication involved), or who are currently enrolled in another medical research study that may conflict with this trial.
- People who have an active serious bacterial infection requiring intravenous antibiotics, an active fungal infection, or a detectable viral infection such as HIV, active hepatitis B, or active hepatitis C.
- People who have a known allergy or sensitivity to the trial medication or its ingredients.
- People who have used any experimental anti-cancer treatment within 30 days before the expected start of trial treatment.
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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Mario Negri Institute for Pharmacological Research
Registry
ClinicalTrials.gov
Start date
30 April 2026
Est. completion
30 April 2029
Where this trial is recruiting
🇮🇹 Italy
Primary endpoints
determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision; evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.