Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 aged 18 or older, of any gender, who are willing to give written consent to take part and to donate tissue and blood samples
• People whose general health and ability to carry out daily activities meets a certain minimum level (known as ECOG performance status 0, 1, or 2 — confirm with trial site)
• People who have been confirmed by laboratory testing to have a specific type of breast cancer that is hormone receptor-positive (ER+) and HER2-negative
• People whose breast cancer is considered high risk at an early stage, based on factors such as how many lymph nodes were affected, tumour size, tumour grade, or results from certain genomic tests — the exact criteria depend on whether surgery was done first or whether chemotherapy or hormone therapy was given before surgery (confirm with trial site)
• People who have a stored tumour tissue sample available from a previous biopsy or surgery
• People who have no signs of cancer that has spread to distant parts of the body, based on scans taken since their diagnosis
• People who are currently receiving standard hormone-blocking therapy (such as aromatase inhibitors, tamoxifen, or a combination) and have been taking it for at least 6 months, with at least 3 more years of this therapy planned — people may join during the first 6 months of hormone therapy and begin the monitoring part of the trial once 6 months have been completed
• People who have had surgery where the surgeon was able to remove the cancer with clear margins (no cancer cells at the edges of the removed tissue), as assessed by local guidelines
• People who are willing to have frequent blood tests throughout the trial
• People of reproductive potential who are willing to use an adequate form of contraception for the required period of the trial (abstinence is acceptable if that is their usual practice)
• For the treatment phase of the trial: people whose blood test results show that their bone marrow, kidneys, and liver are functioning adequately (specific levels will be assessed by the trial site)
• For the treatment phase: people who are post-menopausal, or pre- or peri-menopausal people and men who are receiving ovarian or gonadal suppression through a licensed hormonal injection (GnRH analogue), started at least 2 weeks before treatment begins
• For the treatment phase: women of childbearing potential who have a negative pregnancy blood test before being assigned to a treatment group

Who may not be able to join:

• People who are currently receiving or planning to receive any treatment for their breast cancer other than standard hormone-blocking therapy or a bone-strengthening medication (bisphosphonate)
• People who have previously taken a CDK 4/6 inhibitor drug as part of standard care, unless at least 12 months have passed since completing that treatment
• People who have previously received a full therapeutic dose of fulvestrant (one lower, non-therapeutic dose is permitted)
• People who have been diagnosed with another cancer in the past 5 years, other than certain skin cancers or cervical carcinoma in situ
• People who are currently enrolled in another treatment trial where experimental therapy is continuing after surgery, or who received a CDK 4/6 inhibitor drug as adjuvant (post-surgery) treatment in a clinical trial
• People who have received an unlicensed or experimental treatment within 4 weeks before registering for this trial
• People who have not yet recovered from significant side effects of previous cancer treatments (other than hormone therapy side effects), where those effects are still at a level above grade 1
• People with serious gut or digestive conditions that could affect how oral medications are absorbed, such as Crohn's disease, severe nausea, vomiting, diarrhoea, or previous bowel surgery
• People with other serious or uncontrolled medical conditions that, in the treating doctor's opinion, would make participation unsafe or difficult
• People with significant uncontrolled heart conditions, including a heart attack, chest pain, heart surgery, or heart inflammation within the past 6 months; heart failure with symptoms; certain heart rhythm problems; or a condition called long QT syndrome (including a family history of this)
• People with a history of lung inflammation, scarring of the lungs, or a related lung condition
• People with a known history of HIV
• People with known active Hepatitis B or Hepatitis C infection
• People who are known to be pregnant or breastfeeding
• People with a history of serious blood clotting disorders or who are taking certain blood-thinning medications (though some lower-risk blood thinners such as low molecular weight heparin, low-dose aspirin, or clopidogrel are permitted)
• People with severe liver impairment (Child-Pugh class C) or very poor kidney function (confirm with trial site)
• People who have cancer in both breasts, or multiple separate primary cancers in one breast (a single primary cancer that appears in multiple spots may still be eligible — the treating doctor would assess this)
• For the treatment phase: people who have signs of cancer returning, based on scans taken after a positive ctDNA test result
• For the treatment phase: people with a known allergy to the ingredients in palbociclib or fulvestrant
• For the treatment phase: people who have received any anti-cancer treatment since joining the trial, other than hormone therapy or a bisphosphonate
• For the treatment phase: people who have been diagnosed with a new cancer (other than certain skin cancers or cervical carcinoma in situ) since joining the trial
• For the treatment phase: people who have had major surgery within 4 weeks before starting trial treatment, or who have not recovered from major side effects of such surgery
• For the treatment phase: people currently taking warfarin or similar blood-thinning medications (certain other blood thinners are permitted — confirm with trial site)
• For the treatment phase: people who are currently taking certain medications or herbal supplements, or consuming certain fruits such as grapefruit, pomelo, starfruit, or Seville oranges, that are known to interfere with how the body processes the trial drug, and who cannot stop these at least 7 days before treatment begins
• For the treatment phase: people with a history of not following medical treatment plans as prescribed

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