Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT03768258
  4. Details
NCT03768258 Clinical Trial

Testosterone Implants and the Incidence of Breast Cancer

Breast Cancer Clinical Trial

— TIBCaP  

Official title:
Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03768258
Other study ID # MW0318-TBCP10Y
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2008
Est. completion date December 2018

Study information
Verified date August 2021
Source Millennium Wellness LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.

Description:

A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.

Recruitment information / eligibility
Status Completed
Enrollment 1268
Est. completion date December 2018
Est. primary completion date March 2018
Accepts healthy volunteers
Gender Female
Age group 24 Years to 92 Years
Eligibility Inclusion Criteria: - Female patients treated between March 2008 - March 2013 - Women who received at least two testosterone pellet insertion procedures - Women previously accrued to the prospective cohort study Exclusion Criteria: - Pre-existing breast cancer - Women who received a single testosterone pellet insertion

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone Implant
Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Millennium Wellness LLC

References & Publications (1)

Glaser RL, York AE, Dimitrakakis C. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019 Dec 30;19(1):1271. doi: 10.1186/s12885-019-6457-8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of invasive breast cancer The incidence of invasive breast cancer in women treated with testosterone therapy 10-year results
Secondary Incidence of ductal carcinoma in situ The incidence of DCIS in women treated with testosterone therapy 10-year results
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2

External Links