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 have been diagnosed with invasive breast cancer that remained in the breast and/or lymph nodes after completing chemotherapy before surgery (if no cancer remains in the breast, at least 2mm of invasive cancer must be present in a lymph node).
• People whose breast cancer tested negative for the HER2 protein before treatment, based on standard testing guidelines.
• People whose breast cancer tested negative for both oestrogen and progesterone hormone receptors before treatment (less than 10% of cancer cells showing hormone activity).
• People who received chemotherapy before their breast surgery.
• People who completed all local treatment (surgery and/or radiation) within the past 4 months, and who had surgery that fully removed the tumour with clear margins — either a lumpectomy (followed by whole-breast radiation) or a mastectomy — along with appropriate surgery to check the underarm lymph nodes.
• People whose blood test, taken after completing all pre-surgery treatment, surgery, and radiation, shows detectable tumour DNA in the bloodstream, confirmed by central laboratory testing.
• People who are currently taking bone-strengthening medications (such as bisphosphonates or RANK-ligand inhibitors).
• People who previously received an immune checkpoint inhibitor drug as part of their pre-surgery chemotherapy treatment.
• People who are generally well and able to carry out normal daily activities with little to no limitation (confirmed with trial site using a standard medical scale called ECOG 0 or 1).
• Men and women aged 18 years or older.
• People whose blood counts and organ function (including bone marrow, liver, and kidneys) meet the specific minimum levels required by the trial (confirm with trial site for exact values).
• Women who could potentially become pregnant must have a negative pregnancy test within 7 days before starting treatment (this is not required for women who have had both ovaries and fallopian tubes removed, or a hysterectomy).
• Women who could potentially become pregnant, and men, must agree to use reliable non-hormonal contraception during treatment and for 6 months after the last dose of either study drug, whichever comes later.
• People who are able to understand the study and are willing to sign a written consent form. People who do not speak English may participate in the main trial, but may be excluded from any surveys or questionnaires unless a translator is available to assist them.

Who may not be able to join:

• People who have previously been treated with sacituzumab govitecan, irinotecan, or any similar antibody-drug that targets the same pathway (topoisomerase I), for early-stage breast cancer.
• People who have already received chemotherapy after their breast surgery (all chemotherapy must have been given before surgery to be eligible).
• People who have had a severe allergic reaction to atezolizumab, sacituzumab govitecan, or any of their ingredients.
• People who have signs or imaging evidence that the cancer has spread to other parts of the body (metastatic disease).
• People whose pathology after surgery shows only non-invasive cancer remaining (such as DCIS or LCIS), or who have no remaining cancer cells, or only microscopic amounts in lymph nodes, with none in the breast tissue.
• People who are currently enrolled in another clinical trial testing an investigational treatment.
• People who still have side effects from previous cancer treatment that have not resolved to a mild level, with the exception of hair loss or mild nerve-related symptoms such as tingling or numbness.
• People who have had a major operation (other than a diagnostic procedure) within the 4 weeks before starting the trial, or who are expected to need major surgery during the trial.
• People who have taken antibiotic treatment (by mouth or intravenously) for an active infection within the 2 weeks before starting the trial. (Antibiotics taken regularly to prevent infections, such as urinary tract infections, are generally acceptable — confirm with trial site.)
• People with ongoing serious illnesses such as an active infection requiring treatment, active tuberculosis, serious liver disease (such as cirrhosis), active uncontrolled bleeding problems, uncontrolled diabetes, or uncontrolled high cholesterol, high triglycerides, or high calcium levels.
• People with significant heart problems, including severe heart failure, a heart attack within the past 6 months, unstable chest pain, serious uncontrolled irregular heartbeat, or other significant heart disease.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or unexplained lung inflammation — or people whose pre-trial chest scan shows active lung inflammation. A history of scarring from radiation-related lung changes is generally acceptable (confirm with trial site).
• People with an active autoimmune disease (where the immune system attacks the body), with the exception of an underactive thyroid managed with hormone replacement, coeliac disease, or mild and well-controlled skin conditions such as psoriasis, eczema, lichen simplex chronicus, or vitiligo.
• People with significant digestive system problems that could affect how the study drugs are absorbed, such as active ulcers, severe nausea, vomiting, or diarrhoea, malabsorption conditions, or prior removal of part of the small bowel.
• People with a hereditary heart condition called long QT syndrome, or whose pre-trial heart tracing (ECG) shows a prolonged QT interval.
• People known to be living with HIV, or who test positive for active Hepatitis B or Hepatitis C infection.
• People who have previously had invasive breast cancer in either breast.
• People with a history of another cancer who have not been free of that cancer for at least 5 years — with the exception of thyroid cancer that was fully treated and had not spread to nearby lymph nodes.
• People who have taken certain medications that strongly interact with a liver enzyme called UGT1A1 within the past 4 weeks (or longer depending on the specific drug) — confirm with trial site for specific medications.
• People who have received a live vaccine within the 4 weeks before starting the trial, or who may need a live vaccine during the trial.
• People with a known allergy or hypersensitivity to any component of the study drugs, including ingredients derived from certain cell or antibody manufacturing processes.
• People who have taken systemic immune-suppressing medications (such as steroids, methotrexate, or similar drugs) within 2 weeks before starting the trial, or who are expected to need them during the trial — with some limited exceptions for short-term or low-dose use in specific situations (confirm with trial site).
• People who are pregnant, as the effects of the study drugs on an unborn baby are unknown. People who are breastfeeding must stop breastfeeding before joining the trial and for one month after the last dose of sacituzumab govitecan.

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