Practice Guideline Information Sheet
Guideline Title [Required]
Breast Cancer ChemophrophylaxisDate Submitted [Required] Approved By: (Dept & Person) [Required]
July 2005 / Eric France, MD, Chief, Preventive MedicineWomen’s Health Task Force
Regional Prevention Committee
Contact [Required] person to contact regarding this guideline’s content
Sue Jane FoxDepartment
/ PreventionPhone
/ 303-344-7256 /Author(s)
Sue Jane Fox, Women’s Health Task ForceClinical Category [Required] Choose one (more if needed) from the list below.
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Keywords To aid in searching for the guideline
Tamoxifen, Breast Cancer, Breast Cancer Prevention, Primary Prevention of Breast Cancer, High Breast Cancer RiskAbstract or other summary description of this guideline
Tamoxifen has been used successfully for years to treat breast cancer patients and to reduce the likelihood of recurrence. It has also been shown to be effective in the primary prevention of breast cancer in high risk patients. This guideline describes who might be eligible for the primary prevention use and how to refer these patients for more information.Intended Audience [Required] Click below to change
xAll Providers / xPhysiciansxAll Providers and Staff / xNurses
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Practice Guideline Plan Sheet
What is the intended clinical outcome of implementing this guideline ?
Patients who are at high risk for breast cancer will be identified and offered information about the use of Tamoxifen for primary prevention.What is the implementation plan?
This guideline has been presented to primary care in the past. It will also be available on the pkc website. It was also presented at the Women’s Health Update in August and October 2002.When the STAR research study was initiated, all potential candidates were identified and invited to informational sessions about the study. Those who did not qualify were given the option of counseling with a clinical pharmacist.
Guideline will also be available on the Permanente Knowledge Connection (pkc.kp.org) intranet site.
What is the plan for evaluating the outcome of implementing this guideline?
Monitor referrals to Oncology for consultation re: chemoprophylaxis.Practice Guideline Attachment Sheet
Attachment One: Reference Document [Required]
This is a “complete” statement of the guideline, which might include
1. Standard disclaimer:
These guidelines are informational only and are not intended to substitute for the reasonable exercise of independent clinical judgment of the providers using the guideline. The guidelines are to be used in conjuction with the provider's clinical judgment in developing care and treatment that is designed for the individual needs of the patient.
2. Rationale
3. Target Patient Population
4. Setting for application of the guideline
5. Source of evidence
6. Recommendations
This can be in Word for Windows, Word for Mac, or HTML form
Attachment Two: Web Document [Required]
This is an HTML (World Wide Web) document that contains the briefest clearest possible graphical or text presentation of the guideline’s intended setting, target population and recommendations. The Clinical Tools Group will be happy to work with you in preparing the web document of your guideline.
Additional Attachments:
Patient education materials
Laminated sheet for providers
Clinician education materials
Baselet content
Other ______
Date: Reviewed and Approved July 2005
Title: Breast Cancer Chemoprophylaxis
This guideline is informational only and is not intended or designed to substitute the reasonable exercise of independent judgement by providers in any particular set of circumstances for each patient encounter. The guideline is flexible and is intended to be used as a resource for integration with a sound exercise of clinical judgement. It can be used to create an approach to care that is unique to the needs of each individual patient.
Rationale for the Guideline: Breast cancer is the most frequently diagnosed cancer in women. Risk factors for breast cancer include a mother, sister or daughter with breast cancer; a personal history of breast cancer, atypical hyperplasia on breast biopsy or a diagnosis of LCIS on breast biopsy.
Tamoxifen has been shown to be effective in reducing the incidence of contralateral breast cancer. In the P-1 Trial, it was also shown to be effective in the primary prevention of breast cancer, reducing invasive breast cancers by 45% and noninvasive breast cancers by 47%.
Target Population: Any woman at increased risk for breast cancer
Source of Evidence:
Fisher, Bernard et. al., “Tamoxifen for Prevention of Breast Cancer: Report of National Surgical Adjuvant Breast and Bowel Project P-1 Study”, Journal of the National Cancer Institute 1998;90:1371-88. (Quality of Evidence = I)
Borgen, Patrick I.; “Is Chemoprevention the Next Era of Breast Cancer Litigation?”
Gail, Mitchell H. et. al., “Weighing the Risks and Benefits of Tamoxifen Treatment for Preventing Breast Cancer”, Journal of the National Cancer Institute 1999;91:1829-46.
Smedira, Holly Jane, MD, “Practical Issues in Counseling Healthy Women About Their Breast Cancer Risk and Use of Tamoxifen Citrate”, Archives of Internal Medicine 2000;160:3034-3042.
Methods of Measuring Compliance: Monitoring the number of women receiving Tamoxifen therapy for primary prevention of breast cancer. Monitor referrals to Oncology for chemoprophylaxis consultation.
Responsible Pary(ies): Sue Jane Fox, Prevention, , 303-344-7256
Approval: Chief, Preventive Medicine
Breast Cancer Chemoprophylaxis Guideline
Women at increased risk for breast cancer due to atypical hyperplasia or LCIS on breast biopsy, the presence of the BRCA-1 or 2 gene, or a strong family history (i.e. multiple family members with breast cancer, family history of breast cancer < age 50) should be provided with the information regarding the potential risks and benefits of tamoxifen chemoprophylaxis. These women should be provided with tamoxifen therapy with at least annual monitoring for potential adverse effects if, based on shared decision-making, they choose to start chemoprophylaxis therapy. Patients in this group can be referred to Oncology for review and counseling re the risks and benefits of Tamoxifen.
Potential increased risks with the use of Tamoxifen include endometrial cancer, deep vein thrombosis, pulmonary embolism, stroke, and uterine sarcoma. Recommended monitoring includes annual pap smear and pelvic exam. Women should be asked at least annually about abnormal uterine bleeding and followed with appropriate evaluation and treatment.