Phase 2 N=30 Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate
Atypical Endometrial Hyperplasia · Endometrial Carcinoma
Primary: Best Pathologic Responses — 17; 4; 6; 1 participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=40 Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer
Atypical Hyperplasia · Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia · Endometrial Carcinoma
Primary: Change in Tumor Proliferation — -0.17 percent (represented by mean) of cells
Phase 2 N=150 Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Endometrial Atypical Hyperplasia · Endometrial Adenocarcinoma
Primary: Cumulative CR Rates Within 16 Weeks — 23; 12 Participants
Phase 2 N=20 Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients
Complex Atypical Hyperplasia · Endometrial Cancer
Primary: Complete Response Rate - 6 Months — 80 percentage of participants
Phase 2 N=199 LY353381 in Preventing Breast Cancer in Women With Hyperplasia
Breast Cancer
Primary: Change in Masood Score — -1.1; -0.8 units on a scale
Phase 2 N=55 Study of Breast Cancer Prevention by Letrozole in High Risk Women
Breast Cancer
Primary: Change in Proliferation Rate (Ki-67 by Immunocytochemistry) From Baseline to 6 Months — -1.5; -1.1 percentage of cells stained positive — p=0.92
N/A N=100 Adipocytokines in Endometrial Cancer
Endometrial Cancer · Obesity
Primary: Correlation Between Circulating Levels of These Markers and Demographic Characteristics. — 39; 42; 11; 8 Participants — p=0.026
Phase 2 N=42 Protocol for Women at Increased Risk of Developing Breast Cancer
Breast Cancer
Primary: Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration. — -2.3 Change in % of cells positive for Ki-67
Phase 2 N=72 Protocol for Women at Increased Risk of Developing Breast Cancer
Breast Cancer
Primary: Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 — -1.2; -2.0 percentage of cells staining positive — p=0.71
Phase 2 N=42 Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
DCIS
Primary: Number of Participants With a Change in Ki-67 Level — 15; 5; 3 Participants — p=0.004
Phase 2 N=37 Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
Breast Cancer · Invasive Breast Cancer
Primary: Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy. — 1…
Phase 2 N=42 Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Leiomyoma
Primary: Shrinkage of Fibroids - Size of Fibroids — -0.27; -0.18; 0.07 logcm3 — p=0.43
Phase 2 N=75 Medroxyprogesterone in Treating Patients With Endometrioid Adenocarcinoma of the Uterine Corpus
Endometrial Adenocarcinoma · Endometrial Adenosquamous Carcinoma · Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Primary: Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor…
N/A N=517 KEEPS Mammographic Density And Breast Health Ancillary Study
Mammographic Density · Abnormal Mammogram
Primary: BIRADS Breast Density — 9; 9; 15; 42 participants
Phase 2 N=12 Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS
Breast Cancer · Ductal Carcinoma in Situ - Category
Primary: 18F-FES Uptake in DCIS — 1.43 SUV
N/A N=43 Letrozole as a Treatment of Endometrial Cancer
Endometrial Carcinoma
Primary: Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer — -3.75; 1.583 percentage of Ki67 staining cells — p=0.0373
Phase 2 N=124 Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
Metastatic Breast Cancer
Primary: Number of Participants With and Without Progression Free Survival (PFS) Events — 92; 30 Participants
Phase 2 N=46 Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer
Breast Neoplasms
Primary: Percent Change in Mammographic Density at 1 Year on Exemestane — -2.4 percent change from baseline
Phase 2 N=10 A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women
Adenocarcinoma of the Endometrium
Primary: IHC-based Tissue Markers of Proliferation
Phase 2 N=127 Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer
Ovarian Cancer
Primary: Colony Stimulating Factor (CSF-1) Expression in Ovarian Endosalpingiosis — 5; 130; 50 Modified H-Score — p=0.012
Phase 4 N=219 Quantitative Subharmonic Breast Imaging
Breast Cancer
Primary: Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI) — 69; 24; 126; 58 lesions
Phase 3 N=24 Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
PCOS
Primary: 17OHP Levels After hCG — 3.2; 1.3 ng/ml
Phase 2 N=54 Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Breast Cancer · Precancerous Condition
Primary: Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy — 1.00; -0.05 µM/mM creatinine
Phase 4 N=12 Pilot of Letrozole for Uterine Myomas
Leiomyoma · Uterine Fibroids
Primary: Changes in Fibroid-related Symptoms After Treatment With Letrozole — -10.42; 1.43 units on a scale — p=0.24
Phase 2 N=141 Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
Asherman Syndrome
Primary: the AFS Score at Second-look Hysteroscopy — 1.6; 1.9 units on a scale — p=>0.05
Phase 2 N=36 Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors
Breast Cancer · Stage II Breast Cancer · Stage III Breast Cancer
Primary: Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings — 23; 0 Participants
N/A N=15 Radiofrequency Ablation of Adenomyosis
Adenomyosis
Primary: Post-operative Evidence of Adenomyoma Tissue Ablation Effect by Area (n) as Assessed by Pathological Analysis — 9; 8; 7; 6 treated areas
Phase 3 N=1,083 Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Endometrial Hyperplasia · Osteoporosis
Primary: Percentage of Participants With Hyperplasia at Screening
N/A N=33 Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Oral Contraceptive
Primary: Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups — 7.5; 12.4 Percent of cells staining for Ki67
N/A N=1,704 Radiologic Evaluation and Breast Density (READ)
Breast Cancer
Primary: Mammogram Recall for Additional Imaging — 11.3; 12.3; 9.8 percentage of women recalled