Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
NCT03666819 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-01-06
Summary
This phase II trial studies how well carbon dioxide fractional (CO2RE) laser works in treating participants with stage 0-III hormone receptor-positive breast cancer with vulvovaginal atrophy associated with dryness, inflammation or thinning of the epithelial lining of the vulva and vagina. CO2RE laser is a device that delivers controlled CO2 energy to the vaginal tissue and may help treat vaginal symptoms such as itching, burning, painful sexual intercourse, thickened or thin skin of the vulva, and stinging.
Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Breast Adenocarcinoma
- Dyspareunia
- Estrogen Receptor Positive
- Progesterone Receptor Positive
- Prognostic Stage 0 Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Vaginal Dryness
- Vaginal Itching
- Vulvovaginal Atrophy
Interventions
- DEVICE
-
Carbon Dioxide Fractional Laser
Undergo CO2RE laser therapy
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Saranya Chumsri · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-10
- Primary Completion
- 2021-09-10
- Completion
- 2021-09-10
- FDA Drug
- Yes
- FDA Device
- Yes
More Related Trials
-
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
NCT00194779 ·Status: COMPLETED ·Phase: PHASE2
-
Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
NCT00002873 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
NCT02003209 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Stereotactic Radiotherapy for Breast Cancer
NCT03043794 ·Status: TERMINATED ·Phase: PHASE2
-
Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ
NCT01439711 ·Status: COMPLETED ·Phase: PHASE2
-
Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer
NCT03628066 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of High Dose Vitamin D on Cancer Biomarkers and Breast Cancer Tumors
NCT02856503 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
NCT01319539 ·Status: TERMINATED ·Phase: PHASE2
-
Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery
NCT00665457 ·Status: TERMINATED ·Phase: PHASE2
-
Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery
NCT00769470 ·Status: COMPLETED ·Phase: PHASE2
-
Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer
NCT05319873 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Open Label Trial for Post-Menopausal Women With Newly Diagnosed Operable Breast Cancer
NCT00161291 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer
NCT00206453 ·Status: TERMINATED ·Phase: PHASE2
-
A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
NCT02413008 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
NCT07340658 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer
NCT03179904 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
NCT00262834 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
NCT00617942 ·Status: COMPLETED ·Phase: PHASE2
-
Biology Guided Therapy for Breast Cancer for ER Positive
NCT04965688 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
NCT06065748 ·Status: RECRUITING ·Phase: PHASE3
-
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
NCT06585969 ·Status: WITHDRAWN ·Phase: PHASE3
-
Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery
NCT02658812 ·Status: TERMINATED ·Phase: PHASE2
-
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
NCT02391194 ·Status: COMPLETED ·Phase: PHASE1
-
89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
NCT02065609 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer
NCT06446882 ·Status: RECRUITING ·Phase: NA