No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
250 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Who this trial is looking for
This trial is looking for women who have had breast cancer and are experiencing vaginal dryness. Participants will undergo a laser treatment to help with their symptoms after completing their breast cancer treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have a history of breast cancer treated with curative intent.
I have vaginal dryness that has been bothersome for at least 3 months.
I am at least 22 years old.
I am postmenopausal.
I can read and understand English or Spanish.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
I have had any type of gynecologic cancer.
I have a history of certain connective tissue diseases.
I have had pelvic surgery involving a vaginal incision in the last 6 months.
I have used vaginal estrogen or similar therapies in the last 6 weeks.
I have had any vaginal laser treatment in the past.
I have ongoing invasive cancer or malignancy.
I have medical issues like keloid formation or thin recto-vaginal septum.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be to…
This phase III trial compares the effect of vaginal fractional CO2 laser therapy to placebo for the treatment of vaginal dryness in breast cancer survivors with symptoms of genitourinary syndrome of menopause (GSM). Placebo therapy is an inactive treatment that is designed to mimic as closely as possible the active treatment being studied in a clinical trial. In this trial, patients will not be told whether they will be in the laser treatment group or the placebo group until 6-weeks after the third treatment visit (patient-blinded). At that point, patients who received placebo can elect to receive laser treatment similar to the other group. GSM is group of symptoms that affect the female genital and urinary systems and results from the lack of estrogen. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness. compared to placebo.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation) within 3 months prior to registration.
* Breast cancer survivors not currently on therapy are eligible
* Patients may be receiving ongoing endocri…
Inclusion Criteria:
* Women with a history of breast cancer who have not had exposure to chemotherapy, targeted therapy, immunotherapy and/or radiation) within 3 months prior to registration.
* Breast cancer survivors not currently on therapy are eligible
* Patients may be receiving ongoing endocrine therapy These patients must be receiving adjuvant endocrine therapy prior to registration and intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist.
\* Patients who are receiving endocrine therapy +/- monoclonal therapy like trastuzumab and pertuzumab are eligible
* Patients on targeted therapy such as CD4/6 inhibitors are not eligible. Patients receiving concurrent chemotherapy and immunotherapy are not eligible.
* Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \>= 4 on a 0-10-point scale that has been bothersome for \>= 3 months and for which the patient wants to undergo the study procedure
* No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible
* No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis
* No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingo-oophorectomy) are eligible
* No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and/or androgen therapy within 6 weeks prior to registration
* No other suspected contraindications for undergoing laser therapy
* No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible
* No known concurrent invasive carcinoma/malignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment
* Postmenopausal based on at least one of the following criteria at the time of registration:
* Women 50 or older with no spontaneous regular menses \> 12 months
* On ovarian suppression (i.e., gonadotrophin releasing hormone \[GNRH\] agonist/antagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks
* Bilateral oophorectomy
* Women on aromatase-inhibitor (AI) therapy (i.e., clinically judged to be postmenopausal)
* In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish
* Age \>= 22 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \< 2 cm between the vaginal opening and the anal opening)
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