Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/26/2018 |
| Start Date: | February 2012 |
| End Date: | January 2022 |
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.
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.
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.
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:
We found this trial at
1
site
Baltimore, Maryland 21231
410-955-6190
Phone: 410-955-8804
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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