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Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

NCT ID: NCT01937052

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

329 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-09

Study Completion Date

2024-11-25

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer patients

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.

Sample collection

Intervention Type OTHER

Participants will be offered the option to consent for blood (preferred) or saliva for DNA pharmacogenetic testing, and for additional samples for banking for future studies.

Patient-reported outcomes

Intervention Type BEHAVIORAL

Patient reported outcomes (PROs) will be collected via electronic questionnaires that will be administered to patients at regular intervals per the study calendar; in most cases, this should coincide with medical oncology follow-up.

Interventions

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Sample collection

Participants will be offered the option to consent for blood (preferred) or saliva for DNA pharmacogenetic testing, and for additional samples for banking for future studies.

Intervention Type OTHER

Patient-reported outcomes

Patient reported outcomes (PROs) will be collected via electronic questionnaires that will be administered to patients at regular intervals per the study calendar; in most cases, this should coincide with medical oncology follow-up.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vered Stearns, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Uhelski AR, Blackford AL, Sheng JY, Snyder C, Lehman J, Visvanathan K, Lim D, Stearns V, Smith KL. Factors associated with weight gain in pre- and post-menopausal women receiving adjuvant endocrine therapy for breast cancer. J Cancer Surviv. 2024 Oct;18(5):1683-1696. doi: 10.1007/s11764-023-01408-y. Epub 2023 Jun 1.

Reference Type DERIVED
PMID: 37261654 (View on PubMed)

Verma N, Blackford AL, Thorner E, Lehman J, Snyder C, Stearns V, Smith KL. Factors associated with worsening sexual function during adjuvant endocrine therapy in a prospective clinic-based cohort of women with early-stage breast cancer. Breast Cancer Res Treat. 2022 Dec;196(3):535-547. doi: 10.1007/s10549-022-06750-w. Epub 2022 Oct 5.

Reference Type DERIVED
PMID: 36197536 (View on PubMed)

Other Identifiers

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SKCCC J1189

Identifier Type: OTHER

Identifier Source: secondary_id

NA_00051923

Identifier Type: OTHER

Identifier Source: secondary_id

J1189

Identifier Type: -

Identifier Source: org_study_id