Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Group 1 (Cohort 1) — for people with ER-positive, HER2-negative advanced breast cancer:

• People who have a general health status rated as fully active or able to carry out light work (ECOG score of 0 or 1)
• People whose breast cancer tests positive for estrogen receptors (ER+)
• People for whom hormone-based treatment is recommended and chemotherapy is not recommended at the time of joining, based on national or local treatment guidelines
• People whose cancer has come back or gotten worse after the most recent treatment for breast cancer, confirmed by imaging
• People whose cancer got worse during or after one or two hormone therapy treatments for advanced disease, where at least one of those treatments included a CDK4/6 inhibitor taken for at least 8 weeks before the cancer progressed
• Women who have gone through menopause
• People with a life expectancy of at least 3 months
• People who have a tumor tissue sample available that can be used for testing at a central laboratory
• People who have measurable cancer that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1)
• People with healthy enough blood counts and organ function (confirm with trial site)
• People who are on a stable blood-thinning medication regimen, if they require it

Group 2 (Cohort 2) — for people with ER-positive, HER2-positive advanced breast cancer:

• People with a general health status rated as fully active or able to carry out light work (ECOG score of 0 or 1)
• People with breast cancer confirmed by biopsy or cell testing that has spread to other parts of the body or cannot be cured by surgery
• People whose breast cancer tests positive for both estrogen receptors (ER+) and HER2
• Women who have gone through menopause
• People with a life expectancy of at least 3 months
• People willing to provide a tumor tissue sample for central laboratory testing, if one is available
• People who have previously had hormone therapy for advanced disease, including fulvestrant if it was given more than 28 days before joining the trial (certain other hormone-blocking drugs are not allowed — confirm with trial site)
• People who have measurable cancer that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1)
• People whose heart pumping function (left ventricular ejection fraction) is at or above 50%, as measured by a heart scan
• People with healthy enough blood counts and organ function (confirm with trial site)
• People who are on a stable blood-thinning medication regimen, if they require it

Group 3 (Cohort 3) — for people with ER-positive advanced breast cancer that got worse during or after adjuvant hormone therapy:

• People with a general health status rated as fully active or able to carry out light work (ECOG score of 0 or 1)
• People whose breast cancer tests positive for estrogen receptors (ER+)
• People for whom hormone-based treatment is recommended and chemotherapy is not recommended at the time of joining, based on national or local treatment guidelines
• People with breast cancer confirmed by biopsy or cell testing that has spread to other parts of the body or is locally advanced and cannot be treated with surgery or radiation aimed at a cure
• People whose cancer progressed while on, or within 12 months of finishing, adjuvant hormone therapy (aromatase inhibitor or tamoxifen); if a CDK4/6 inhibitor was part of earlier treatment, the cancer progression must have occurred more than 12 months after finishing that CDK4/6 inhibitor
• Women who have gone through menopause, including women using or starting a hormone-suppressing injection (LHRH agonist) before joining the trial
• People with a life expectancy of at least 6 months
• People with healthy enough blood counts and organ function (confirm with trial site)
• People with measurable cancer that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1)
• People who have evidence of a specific gene change (PIK3CA mutation) based on prior blood or tissue test results; if prior results are not available, a new blood sample will need to be sent to a central laboratory for testing

Who may not be able to join:

Applies to most or all groups:

• People who have previously received any of the specific study treatments being tested in this trial
• People who have taken an experimental treatment within the last 28 days
• People who have had systemic (whole-body) cancer treatment within the last 2 weeks, or within 5 half-lives of that drug
• People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within the past 14 days or 5 drug half-lives, whichever is longer
• People who still have significant side effects from previous cancer treatment (above a mild level), except for hair loss of any severity or mild-to-moderate nerve-related symptoms
• People who have had a major surgical procedure in the 4 weeks before starting the trial, or who are expected to need one during the trial
• People with a history of another cancer (other than breast cancer) in the past 2 years, except for cancers with a very low risk of spreading or causing death
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained repeatedly
• People with pain caused by the tumour that is not being adequately controlled
• People with uncontrolled or symptomatic high calcium levels in the blood
• People with brain or spinal fluid metastases that are causing symptoms, have not been treated, or are getting worse
• People with a history of cancer spreading to the lining around the brain or spinal cord (leptomeningeal disease)
• People with active tuberculosis
• People who have had a serious infection in the past 4 weeks
• People who have received antibiotic treatment (oral or intravenous) for an infection in the past 2 weeks
• People with a history of certain lung conditions, including scarring of the lung tissue, or evidence of active lung inflammation on a recent scan
• People with active heart disease or a significant history of heart problems
• People who test positive for HIV
• People with active Hepatitis B or Hepatitis C infection
• People with active inflammatory bowel disease, ongoing diarrhea, short bowel syndrome, or a history of major stomach or upper bowel surgery that could affect how medications are absorbed
• People with a known allergy or sensitivity to any of the study drugs or their ingredients

Cohort 1 only — additional reasons a person may not be eligible:

• People whose breast cancer is HER2-positive
• People currently taking hormone replacement therapy
• People who have previously had chemotherapy for metastatic breast cancer (except single-agent capecitabine)
• People who only qualify for the control (standard) treatment arm

Cohort 2 only — additional reasons a person may not be eligible:

• People who are breathless at rest due to advanced cancer or another condition requiring continuous oxygen
• People who have been taking oral corticosteroids (steroid tablets) continuously for more than 3 months at a dose equivalent to 10 mg/day of methylprednisolone or higher (inhaled steroids are not included in this restriction)

For specific treatment combinations, additional reasons a person may not be eligible include (confirm which apply with the trial site):

• People with certain lung, heart, bowel, eye, immune system, or blood sugar conditions
• People who have previously received certain targeted therapies (such as PI3K, AKT, mTOR, or immune checkpoint inhibitors)
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or shortly after
• People who have recently received certain vaccines, steroids, or immune-modifying medications
• People with Type 1 diabetes, or Type 2 diabetes requiring insulin or ongoing medication at the time of joining (depending on the treatment arm)
• People with certain abnormal heart rhythm findings
• People with active bleeding disorders or a history of certain blood conditions
• People with a history of fainting related to heart problems, dangerous heart rhythms, or sudden cardiac arrest
• People with a history of severe allergic reactions to certain types of laboratory-made antibodies

Cohort 3 only — additional reasons a person may not be eligible:

• People whose breast cancer is HER2-positive
• People who have previously received certain hormone-blocking drugs (SERDs such as fulvestrant, or newer types), or certain other experimental breast cancer-targeted therapies
• People who have previously received PI3K, AKT, or mTOR inhibitor treatments
• People who have taken an experimental treatment within the last 28 days
• People who still have significant side effects from previous cancer treatment (above a mild level), except for hair loss of any severity or mild-to-moderate nerve-related symptoms

Important: Always verify eligibility with the trial site directly before applying.