Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Kathryn Ruddy, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00903162
First received: May 5, 2009
Last updated: January 30, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer, but it has not been accepted as a standard of care treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: leuprolide Drug: letrozole Drug: zoledronic acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Extended Endocrine Therapy for Premenopausal Women With Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine the tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To explore the effect of ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To evaluate the effect of OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Letrozole-Leuprolide
Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.
|
Drug: leuprolide
Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
Other Name: Lupron
Drug: letrozole
Taken orally once a day 6-8 weeks after initial leuprolide administration
Other Name: Femara
Drug: zoledronic acid
If desired, given intravenously every 6 months for a total of 4 injections (optional)
|
Detailed Description:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 tamoxifen
- 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 days)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903162
Locations
| United States, Colorado | |
| University of Colorado | |
| Denver, Colorado, United States, 80217 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Newton Wellesley Hospital | |
| Newton, Massachusetts, United States, 02462 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Novartis
Investigators
| Principal Investigator: | Kathryn Ruddy, MD, MPH | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Kathryn Ruddy, MD, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00903162 History of Changes |
| Other Study ID Numbers: | 08-280 |
| Study First Received: | May 5, 2009 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
hormone-receptor positive tamoxifen letrozole zoledronic acid leuprolide |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Leuprolide Letrozole Zoledronic acid Diphosphonates Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 18, 2013