Breast CancerPhase 2NCT00903162
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
A Phase 2 study testing leuprolide, letrozole and zoledronic acid in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- leuprolide, letrozole and zoledronic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2009to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Colorado
Denver, Colorado, 80217
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- leuprolide, letrozole, zoledronic acid
- Keywords
- hormone-receptor positive, tamoxifen, letrozole, zoledronic acid, leuprolide
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprolideDrug
Also called Lupron
Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years
letrozoleDrug
Also called Femara
Taken orally once a day 6-8 weeks after initial leuprolide administration
zoledronic acidDrug
Also called Zometa
If desired, given intravenously every 6 months for a total of 4 injections (optional)
| Study group | Role | What they receive |
|---|---|---|
| Letrozole-Leuprolide | Experimental | 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. Receives: Drug: leuprolide; Drug: letrozole; Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.
The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.
Measured: 1 year
Secondary outcomes (2)
Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.
Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.
Measured: 2 years
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.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Novartis
- Responsible party
- Principal investigator, Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Ann Partridge, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903162
- Sponsor's protocol ID
- 08-280
- Status last verified
- Jan 2016
- First submitted
- 5 May 2009
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00903162
- Acronym / sponsor ID
- 08-280
- Conditions
- Breast Cancer
- Keywords
- hormone-receptor positive, tamoxifen, letrozole, zoledronic acid, leuprolide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Novartis
- Study start
- May 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Posted 4 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole-Leuprolide | Experimental | Drug: leuprolide, Drug: letrozole, Drug: zoledronic acidPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leuprolideAlso: LupronGiven intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years | Drug | Letrozole-Leuprolide |
| letrozoleAlso: FemaraTaken orally once a day 6-8 weeks after initial leuprolide administration | Drug | Letrozole-Leuprolide |
| zoledronic acidAlso: ZometaIf desired, given intravenously every 6 months for a total of 4 injections (optional) | Drug | Letrozole-Leuprolide |
Primary outcome
Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.
Time frame: 1 year
The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.
2 secondary outcomes
Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.
Time frame: 2 years
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.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Partridge, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leuprolide, letrozole and zoledronic acid in people with Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.