Phase 3 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 have been diagnosed with breast cancer that is hormone receptor positive (estrogen and/or progesterone receptor positive) and HER2 negative, confirmed by a biopsy, according to standard medical guidelines.
• People whose breast cancer is classified as clinical stage II or III, including those with a type called inflammatory breast cancer.
• People who have multiple tumours in the same breast, or tumours in both breasts at the same time, as long as all biopsied tumours are hormone receptor positive and HER2 negative, and at least one tumour has a MammaPrint High-2 score.
• People who either have enough stored tumour tissue available to be tested for a MammaPrint score during the study, or who already have a MammaPrint High-2 (MP2) score from a test done within the last 12 weeks.
• People whose cancer has not spread to other parts of the body (no distant metastases).
• People who have not received any prior treatment for their current breast cancer, and whose doctors consider them suitable candidates for the chemotherapy and immunotherapy drugs used in this trial (doxorubicin, paclitaxel, and durvalumab).
• People aged 18 or older at the time of registration.
• People who weigh more than 30 kg.
• People who have a general health and activity level rated as 0, 1, or 2 on the Zubrod scale (a standard measure of how much a person's illness affects their daily activities).
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People whose blood test results before the treatment phase show healthy enough levels of white blood cells, platelets, liver function, and kidney function, as assessed by the trial site within 28 days before joining the treatment part of the trial.
• People with HIV who are on effective treatment and have an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have an undetectable viral load while on suppressive therapy, tested within the past 6 months.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load within the past 6 months.
• People with adequate heart function, rated as Class 2B or better on a standard heart health scale, if they have a known history of heart disease or have previously received heart-affecting treatments.
• People who are able to use effective contraception during treatment and for 6 months after treatment ends, and who have a negative pregnancy test at screening (for those who could become pregnant).
• People with well-controlled diabetes, meaning a recent HbA1c blood sugar test result below 9.0%.
• People who are willing to sign a consent form and agree to the terms of the study.

Who may not be able to join:

• People whose breast cancer has spread to other parts of the body (metastatic disease).
• People whose breast cancer has come back locally after previous treatment (locally recurrent breast cancer).
• People whose primary breast tumour cannot be found, with cancer only detected in the lymph nodes under the arm, as the MammaPrint test has not been validated for tissue taken from lymph nodes.
• People who have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, targeted biological therapy, or hormonal therapy.
• People who have an autoimmune disease that has required treatment with immune-suppressing medications, steroids, or disease-modifying drugs within the past two years (note: routine hormone or insulin replacement therapy does not count as immune-suppressing treatment).
• People who have had lung inflammation (pneumonitis) not caused by infection that required steroid treatment, or who have signs of active lung inflammation within the past two years.
• People who are pregnant or breastfeeding, or who are not willing or able to use effective contraception during and for 6 months after treatment.
• People who have received certain live vaccines (such as measles, mumps, rubella, chickenpox, shingles, yellow fever, rabies, BCG, or oral typhoid) within 28 days before the treatment phase of the trial (note: standard flu shots and COVID-19 vaccines are generally allowed, but nasal spray flu vaccines are not).
• People planning to receive other cancer treatments not specified in this trial's protocol at the same time as trial treatment.
• People with uncontrolled diabetes, defined as a blood sugar (HbA1c) level of 9.0% or higher within 28 days before joining the treatment phase.
• People whose blood test results show their white blood cell counts, platelet counts, liver function, or kidney function do not meet the minimum levels required by the trial (confirm specific thresholds with the trial site).
• People whose MammaPrint test result is not High-2 (MP2) status.

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