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 (early breast cancer, before surgery or main treatment):

• You have been confirmed by biopsy to have early-stage breast cancer (Stage I–III) that is hormone receptor-positive (ER+), HER2-negative, and has a certain level of a growth marker called Ki-67 (at least 10%)
• You are willing and able to provide tumor tissue samples before and during treatment
• You are generally healthy and able to carry out normal daily activities with little to no limitation (confirm with trial site)
• You are able to swallow capsules or tablets
• You are a premenopausal woman (your periods have not stopped permanently)
• If you could become pregnant, you are willing to use one reliable non-hormonal method of contraception during and after treatment, as the study requires
• Your liver, kidneys, and other organs are working well enough to take part (confirm with trial site)

Group 2 (early breast cancer, after surgery and hormone therapy):

• You have been diagnosed with early-stage hormone receptor-positive (ER+), HER2-negative breast cancer that has been surgically removed, with no sign the cancer has spread to other parts of the body
• You have already completed your main local treatment, such as surgery and/or radiotherapy
• You have taken hormone-blocking therapy for at least 4.5 years, or at least 2 years without any planned ovarian suppression treatment
• You are generally healthy and able to carry out normal daily activities with little to no limitation (confirm with trial site)
• You are able to swallow capsules or tablets
• You are a premenopausal woman (your periods have not stopped permanently)
• If you could become pregnant, you are willing to use one reliable non-hormonal method of contraception during and after treatment, as the study requires
• Your liver, kidneys, and other organs are working well enough to take part (confirm with trial site)

Who may not be able to join:

Group 1:

• You have breast cancer in both breasts, cancer that has spread to other parts of the body, inflammatory breast cancer, or a breast cancer with no known primary site
• You have previously had both ovaries removed or had your ovaries treated to stop them working
• You have a serious ongoing medical condition (confirm with trial site for details)
• You have had major surgery in the 28 days before joining the trial
• You have a history of another cancer, unless it was non-melanoma skin cancer, early-stage uterine cancer, or a non-invasive cervical or other in-situ cancer — or unless you have been cancer-free without any treatment for at least 1 year
• You are planning to receive other cancer treatments at the same time as this trial
• You have previously had any treatment for breast cancer (invasive or non-invasive)
• You have previously had radiotherapy to the chest wall on the same side as your breast cancer
• You have previously taken any anti-oestrogen medication, including for bone health or breast cancer prevention
• You have received a hormone treatment called a GnRH agonist in the 12 months before joining the trial
• You are currently taking any hormone therapy (such as the contraceptive pill or hormone replacement therapy)

Group 2:

• You have ovarian cysts larger than 1 centimetre found at your screening appointment
• You have breast cancer that has spread to other parts of the body, inflammatory breast cancer, or a breast cancer with no known primary site
• You have previously had both ovaries removed or had your ovaries treated to stop them working
• You have a serious ongoing medical condition (confirm with trial site for details)
• You have had major surgery in the 28 days before joining the trial
• You have a history of another cancer, unless it was non-melanoma skin cancer or a non-invasive cervical or other in-situ cancer — or unless you have been cancer-free without any treatment for at least 1 year
• You finished or stopped your hormone-blocking therapy more than 6 months before your screening appointment
• You have previously been treated with a type of hormone-blocking drug called a SERD (confirm with trial site for examples)
• You are currently taking any hormone therapy (such as the contraceptive pill or hormone replacement therapy)

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