Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

Completed

• Conditions: Breast Cancer
• Interventions: Other: Sample collection; Behavioral: Patient-reported outcomes

• Registration Number: NCT01937052
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

The purpose of this project is to establish a repository of information and samples from breast cancer patients or those at high risk of developing breast cancer, who are initiating hormone therapy as part of standard clinical care or prevention. This repository will include patient reported outcomes and other questionnaires, information on medication use, data about adherence to the hormone therapy and tumor characteristics, including prospectively collected samples.

Detailed Description

This research is being done to learn more about the side effects of breast cancer hormone therapy and if a person's genetic information may help us to develop a way to predict the side effects a patient may have and how best to treat them. In addition, the investigators hope to look at how the side effects from hormone therapy influence a patient's willingness to continue hormonal treatment.

Men and women being prescribed hormone therapies including Tamoxifen, Raloxifene (Evista), Anastrozole (Arimidex), Letrozole (Femara), or Exemestane (Aromasin), by their oncologist for either prevention of breast cancer or treatment of breast cancer may join.

The decision of which hormone therapy to receive is the decision of the patient and physician, this study will collect samples and patient-reported outcomes during this routine, standard of care and will not direct any treatment decisions or interventions in any way.

Study Timeline

• Study Start: 2012-05-09
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-09
• Primary Completion: 2022-01-03
• Study Completion: 2024-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

• Male or female
• 18 years of age or older
• Physically and cognitively able to complete the questionnaires
• Meet one of the following categories: 1) Initiating hormonal therapy for breast cancer prevention. All patients planned to initiate hormonal therapy with either Tamoxifen, Raloxifene (Evista®), Anastrozole (Arimidex®), Letrozole (Femara®) or Exemestane (Aromasin®) are eligible; concomitant use of Zoladex or Lupron is permitted; 2) Patients with histologically proven ductal carcinoma in situ (DCIS/stage 0) or stage I-III invasive carcinoma of the breast that is estrogen (ER) and/or progesterone (PR) positive by immunohistochemical staining, who are considering one of the above listed SERMs or AIs. These patients must have completed any planned chemotherapy and local therapy (e.g., lumpectomy or mastectomy); however, enrollment/initiation of hormonal therapy on study may be done prior to completion of radiation and/or biologic therapy (e.g., trastuzumab) at the discretion of the treating team; or, 3) The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
• Patients transitioning from one hormonal agent listed above to another may be enrolled prior to initiation of the new medication.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients	Patient-reported outcomes	All patients planned to initiate hormonal therapy with either Tamoxifen, Raloxifene (Evista®), Anastrozole (Arimidex®), Letrozole (Femara®) or Exemestane (Aromasin®) are eligible to participate in sample collection and data for patient-reported outcomes/questionnaires.
Breast cancer patients	Sample collection	All patients planned to initiate hormonal therapy with either Tamoxifen, Raloxifene (Evista®), Anastrozole (Arimidex®), Letrozole (Femara®) or Exemestane (Aromasin®) are eligible to participate in sample collection and data for patient-reported outcomes/questionnaires.

Primary Outcome Measures

Name	Time	Method
Sample and data collection	10 years	To collect high quality prospective data regarding individual genetic profiles, medication use and patient reported outcomes on hormone therapy, which can be used to validate correlations that have been observed in other studies.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States