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| ID | Type | Description | Link |
|---|---|---|---|
| SKCCC J1189 | Other Identifier | SKCCC at Johns Hopkins | |
| NA_00051923 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sample and data collection | 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. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vered Stearns, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287-0013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37261654 | Derived | 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. | |
| 36197536 | Derived |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood (for example: serum, plasma, and whole blood) and saliva samples
| Patient-reported outcomes | 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. |
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| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |