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Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

- Participants will be given a monthly intramuscular injection of leuprolide. Six to
eight weeks after the first leuprolide injection, participants will be instructed to
begin taking letrozole pills by mouth at home each day.

- During this research study, participants will also be offered injections of zoledronic
acid to preserve bone mineral density. If desire, these injections will be given every
6 months for a total of 4 injections during the course of the research study.

- The treatments in this research study may increase the risk of bone density loss, so
vitamin D and calcium supplements will be recommended to participants.

- The following tests and procedures will be performed during the research study:
Physical Exam (every visit); Blood tests; Urine test (beginning and end of treatment);
Imaging (annual mammograms); Bone Density (DXA) Scan (beginning and end of treatment);
Questionnaires (throughout the study).

- Participants will be on this study for about two years.

Inclusion Criteria:

- Women 18 years of age or older

- History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of

- No current evidence of recurrent invasive disease or metastatic disease. Patients
may have a history of bilateral breast cancer

- Premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28

- Liver function tests and creatinine <2.5 times the upper limit of normal within the
28 days prior to enrollment

- ECOG Performance Status 0-1

- Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization,
abstinence, etc) and no other hormonal therapy during trial and until 3 months after
letrozole is stopped

- Negative pregnancy test within 14 days prior to enrollment

- Patient must be able to speak, read and write in English

Exclusion Criteria:

- Previous treatment with an oral or IV bisphosphonate in the prior two years

- History of cancer other than breast cancer within 5 years excluding basal/squamous
cell skin carcinoma in situ of the cervix

- Women with evidence of current local recurrence or metastatic breast cancer

- Pregnant women

- Nursing women

- Women who are currently taking tamoxifen and are unwilling to stop this medication

- Women with a known deleterious BRCA 1 or BRCA 2 mutation

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kathryn Ruddy, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

July 2015

Related Keywords:

  • Breast Cancer
  • hormone-receptor positive
  • tamoxifen
  • letrozole
  • zoledronic acid
  • leuprolide
  • Breast Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of ColoradoDenver, Colorado  80217
Newton Wellesley HospitalNewton, Massachusetts  02462