A Phase 3 interventional study of Laser Therapy and Sham Intervention in Vaginal Atrophy and Breast Carcinoma, sponsored by Alliance for Clinical Trials in Oncology. Recruiting at 3 sites in United States. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
Among 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology — 5 open to participants now, 15 under way, 12 of them phase 3. Breast Neoplasms · Alliance for Clinical Trials in Oncology.
Among the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology, this one is the 31st largest by planned enrollment of the 77 interventional ones, is one of 2 that started in 2026, is one of 41 in phase 3, reaches primary completion later than 11 of the 14 other live ones, and was the 92nd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 250 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →5 of the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology are open now, in 3 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 22 Years and older · female · no healthy volunteers.
The full table on the hub →96 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 2 started in 2026.
Median enrollment 201 across the 77 interventional studies, 530 across the 18 observational. Of the 77 that completed or were terminated, 29 (38%) have results posted.
Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
5 of the studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01953588Phase 3Alliance for Clinical Trials in OncologyFulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery | 2027-04-01 |
| NCT04711109Phase 3Alliance for Clinical Trials in OncologyStudying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation | 2027-07 |
| NCT05751668Alliance for Clinical Trials in OncologyFinding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel | 2026-11-15 |
| NCT05334069Alliance for Clinical Trials in OncologyCollecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection | 2027-01-31 |
| NCT07059884Alliance for Clinical Trials in OncologyDistance-Based Exercise to Preserve Function and Prevent Disability | 2027-07-01 |
Among the 96 studies in Breast Neoplasms by Alliance for Clinical Trials in Oncology, from their registry updates:
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.
PRIMARY OBJECTIVE:
I. To determine whether vaginal fractional carbon dioxide (CO2) laser treatment is superior to vaginal placebo procedure in improving the severity of vaginal dryness, based on an 11-point (0-10) patient reported numerical analog scale.
SECONDARY OBJECTIVES:
I. To determine whether vaginal fractional CO2 laser treatment is superior to vaginal placebo procedure in improving patient-reported vaginal discomfort during sexual activity, based on the vaginal discomfort domain of the Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (v.) 2.0 Brief Profile-Female.
II. To determine whether vaginal fractional CO2 laser therapy results in improvement in patient-reported quality of life, based on a single item 11-point numerical analog scale.
III. To evaluate potential toxicities associated with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized at a 2:1 ratio to Arm I and Arm II.
ARM I: Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, and 3,6, 12, 18 and 24 months after the last procedure visit.
Inclusion Criteria:
Patients may be receiving ongoing endocrine therapy These patients must be receiving 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
based on at least one of the following criteria at the time of registration:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo vaginal fractional CO2 laser therapy over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Device: Laser Therapy · Other: Questionnaire Administration · Other: Quality of Life Assessment
Patients undergo placebo procedure over 20-30 minutes every 6 weeks for 3 treatments in the absence of disease progression or unacceptable toxicity.
Device: Sham Intervention · Other: Questionnaire Administration · Other: Quality of Life Assessment
Undergo vaginal fractional CO2 laser therapy
Undergo placebo procedure
Ancillary studies
Ancillary studies
Changes in patient reported vaginal dryness severity
Will use an 11-point (0-10 scale) numerical analog scale to assess patient reported severity of vaginal dryness. Higher scores represent worse symptoms (0: None - 10: Worst possible). The vaginal dryness scores at each time point will be summarized separately by treatment arm using the mean (standard deviation) and median (range). The score changes from baseline to the 18-week time point (T4) will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate.
Time frame: Up to 18 weeks
Changes in vaginal discomfort during sexual activity (for sexually active subset of study population only)
Assessed using the Vaginal discomfort domain of Patient Reported Outcomes Measurement Information System (PROMIS) Sexual Function version (V) 2.0 Brief Profile - Female (only the sexually active women will be evaluable for this, which is estimated to be approximately 50% of the population). Higher scores represent more discomfort (1: None - 5: A lot). Change in the vaginal discomfort domain of the PROMIS Sexual Function v. 2.0 Brief Profile-Female from baseline to each post-therapy-initiation time point will be summarized by treatment arm and will be compared as described for the primary endpoint.
Time frame: Baseline up to 24 months after completion of treatment
Change in quality of life
Evaluated using 11-point (0-10) numerical analog scale. Higher scores represent better quality of life (0: As bad as it can be - 10: As good as it can be). Change in patient reported quality of life from baseline to each post-therapy initiation time point will be summarized and compared as described for the primary endpoint.
Time frame: Baseline up to 24 months after completion of treatment
Incidence of adverse events associated with vaginal fractional CO2 laser therapy
Incidences of toxicities in the fractional CO2 laser therapy arm will be summarized by type. Common toxicities that occur in both arms will be summarized and compared between arms using the Chi-square test or Fisher's exact test, as appropriate.
Time frame: Up to 24 months after completion of treatment
Not enrolling at this site.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Alliance for Clinical Trials in Oncology →