Phase 3 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:

• Women who have had breast cancer that was treated with the goal of curing it, and who finished their main treatment (such as surgery, chemotherapy, targeted therapy, immunotherapy, and/or radiation) at least 12 months before joining the trial. Ongoing trastuzumab/pertuzumab treatment is allowed.
• People who are currently taking ongoing hormone-blocking treatment (such as an aromatase inhibitor or tamoxifen, with or without ovarian suppression) — though this type of treatment is not required to be eligible. Those already on this type of treatment must have been on the same regimen for at least 6 months before joining, and must plan to stay on it for the 4 months of the study treatment.
• People who report vaginal dryness, with or without painful sex, that rates at least 4 out of 10 in severity on average, has been bothering them for at least 3 months, and is something they want to treat through the study.
• People with no signs of breast cancer that has spread to other parts of the body (scans are not required to confirm this for eligibility purposes).
• People who are postmenopausal, based on at least one of the following: aged 50 or older with no regular periods for more than 12 months; on ovarian suppression treatment for at least 6 months with plans to continue for at least 18 more weeks; have had both ovaries surgically removed; or are on an aromatase inhibitor and are clinically judged to be postmenopausal.
• People aged 22 or older.
• People who are well enough to carry out normal daily activities, with little to no limitation (this is measured using a standard medical scale called ECOG performance status 0 or 1 — confirm with trial site if unsure).
• People who are able to speak, read, and understand English or Spanish, in order to complete required questionnaires.
• People with a prior cancer diagnosis other than breast cancer may still be eligible, as long as that cancer or its treatment is not expected to interfere with the study, and they are not currently receiving treatment for it. People with non-invasive cancer (carcinoma in situ) are also eligible.
• People who have had a history of pre-cancerous cervical cell changes (cervical intraepithelial neoplasia) are eligible.

Who may not be able to join:

• People with a history of any gynaecologic cancer, pre-cancerous vaginal cell changes (vaginal intra-epithelial neoplasia), radiation to the pelvic area, or pelvic reconstructive surgery using mesh.
• People with a history of certain autoimmune or connective tissue conditions, including scleroderma, lupus, systemic sclerosis, mixed or undifferentiated connective tissue disorder, collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosus, or vulvar vestibulitis.
• People who have had pelvic surgery involving a vaginal incision within the 6 months before joining (though keyhole surgery to remove the ovaries and fallopian tubes is allowed).
• People who have used systemic or vaginal oestrogen, progesterone, vaginal prasterone, ospemifene, or androgen therapy within the 6 weeks before joining.
• People who have had any type of vaginal laser treatment at any time in the past.
• People who currently have another active invasive cancer or malignancy.
• People with a known medical history of keloid scarring, a genital fistula, or a thin wall between the vagina and rectum (defined as less than 2 cm between the vaginal and anal openings).
• People with any other known reason that would make laser therapy unsafe for them (confirm with trial site).

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