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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

NCTNCT00903162 (opens ClinicalTrials.gov in a new tab)Other id08-280
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
17 participants (actual)
Sponsor
Dana-Farber Cancer Institute · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2009
Primary completion
Jul 2014
Completion
Sept 2014
First posted
18 May 2009 (estimated)
Last update posted
18 Apr 2016 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012201320142015
  1. Ph 2

    Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

    NCT00903162

    May 2009 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • leuprolideDrug
  • letrozoleDrug
  • zoledronic acidDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.

    Time frame · 1 year

    Registry description

    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.

Secondary outcomes(2)

  1. Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.

    Time frame · 2 years

    Registry description

    Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.

  2. 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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 year

Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.

GroupValue (participants)
Letrozole-Leuprolide4
Secondary and other outcome results(2)
Secondary outcome· 2 years

Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.

GroupValue
Letrozole-Leuprolidenot posted
Secondary outcome· 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.

GroupValue
Letrozole-Leuprolidenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Letrozole-LeuprolidePatients 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. 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 letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)–0 / 1712 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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