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:

• People who agree to provide blood samples for central laboratory testing of certain genetic markers and other biological indicators.
• People who have been diagnosed with estrogen receptor-positive (ER+), HER2-negative breast cancer that has either spread to nearby tissue or to other parts of the body, confirmed through a tissue or cell sample.
• People who are postmenopausal, have had both ovaries surgically removed, or — if still having periods or in the transition to menopause — agree to receive and continue a specific hormone-suppressing injection therapy (called an LHRH agonist) throughout the study.
• People whose cancer has progressed during or after standard treatment, or who were unable to tolerate, were not eligible for, or declined standard treatment.
• People who have a history of hormone therapy meeting one of these conditions: cancer came back during or within one year of completing at least two years of hormone therapy after surgery, OR cancer progressed after at least one round of hormone therapy for advanced disease lasting at least six months.
• People who have received no more than two prior rounds of chemotherapy for advanced breast cancer (note: antibody-drug conjugates count as chemotherapy in this trial).
• People who have not previously received any selective estrogen receptor degrader (SERD) treatment other than fulvestrant.
• People joining the everolimus combination group must have previously received a CDK4/6 inhibitor therapy.
• People joining the CDK4/6 inhibitor combination group must have received no more than one prior CDK4/6 inhibitor treatment; if that treatment was given after surgery, the cancer must have returned more than 12 months after finishing it.
• People who have at least one area of cancer that can be assessed (and measured, for the Phase II part of the trial) using standard imaging guidelines.
• People whose organ function and bone marrow function meet the required levels at the time of screening.

Who may not be able to join:

• People whose cancer has spread to the membranes surrounding the brain or spinal cord, or who have spinal cord compression, or whose brain metastases are causing symptoms or are considered unstable.
• People with a history of, or ongoing, significant digestive system conditions that may affect how the body absorbs oral medications.
• People with cancer spread to internal organs causing symptoms, or with significant fluid build-up in the chest, abdomen, around the heart, or in the lung tissue that is unstable (prior drainage treatment must have been stable for more than 14 days).
• People who have previously been treated with any SERD or similar medication other than fulvestrant.
• People who have not waited long enough after finishing prior cancer treatments before joining the trial (confirm with trial site for specific timeframes).
• People with Type 1 diabetes, or Type 2 diabetes that is not well controlled at screening — this applies only to those joining the everolimus combination group.
• People with a history of lung inflammation (interstitial lung disease or drug-induced lung inflammation), or evidence of active lung inflammation on a chest scan within four weeks before starting the trial.
• People with severe lung disease at screening, including severe asthma, severe chronic obstructive pulmonary disease (COPD), or certain other serious lung conditions (confirm with trial site for full list).
• People with high blood pressure that remains uncontrolled despite medication, specifically a top reading above 150 mmHg or a bottom reading above 95 mmHg.
• People with active heart disease or a significant history of heart problems.

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