Clinical trial · Observational
Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database
NCT01937052CI-TRIAL-00083699completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-reported outcomes | Behavioral | — | UNRESOLVED |
| Sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients
- description
- 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.
- interventionNames
- Other: Sample collection
- Behavioral: Patient-reported outcomes
Primary outcomes (1)
- measure
- Sample and data collection
- timeFrame
- 10 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDUhelski 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. PMID 37261654
- DERIVEDVerma 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. PMID 36197536