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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprolide | Drug | Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Partridge, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80217 | United States | ||
| Beth Israel Deaconess Medical Center |
A total of 17 patients were enrolled in this study; however, only 16 patients started treatment. One patient withdrew from the study before starting treatment.
Potential patients were approached in the Dana-Farber Breast Oncology clinic and Newton Wellesley Hospital. Eligible patients were then presented with the study and given an opportunity to sign consent. The recruitment period ran from March 30th 2009 to May 1st, 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity. | Posted | Number | participants | 1 year |
|
Adverse events data were collected for the two years that patients were on study treatments.
Adverse events data were collected from all participants enrolled in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot Flashes | Endocrine disorders | Non-systematic Assessment | Hot Flashes/Flushes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Partridge, MD, MPH | Dana-Farber Cancer Institute | 617.632.3800 | ann_partridge@dfci.harvard.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D000077289 | Letrozole |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| letrozole | Drug | Taken orally once a day 6-8 weeks after initial leuprolide administration |
|
|
| zoledronic acid | Drug | If desired, given intravenously every 6 months for a total of 4 injections (optional) |
|
|
| 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. |
| 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | This data was not collected nor analyzed because of too few participants to be meaningful. | Posted | 2 years |
|
|
| Secondary | 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. | This data was not collected nor analyzed because of too few participants to be meaningful. | Posted | 2 years |
|
|
| 0 |
| 17 |
| 12 |
| 17 |
| Vaginal Dryness | Reproductive system and breast disorders | Non-systematic Assessment | Dryness of the vagina |
|
| Headache | Nervous system disorders | Non-systematic Assessment | disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve. |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Muscle pain |
|
| Flu-like Symptoms, Fever, or Rigors | General disorders | Non-systematic Assessment | A disorder characterized by a group of symptoms similar to those observed in patients with the flu. It includes fever, chills, body aches, malaise, loss of appetite and dry cough. |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | A disorder characterized by a queasy sensation and/or the urge to vomit. |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment | A disorder characterized by difficulty in falling asleep and/or remaining asleep. |
|
| Fatigue | General disorders | Non-systematic Assessment | A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities. |
|
| Sexual Dysfunction | Reproductive system and breast disorders | Non-systematic Assessment | A disorder characterized by a decrease in sexual desire or function. |
|
| Injection Site Reaction or Rash | General disorders | Non-systematic Assessment | A disorder characterized by an intense adverse reaction (usually immunologic) developing at the site of an injection. |
|
| Vaginal Discharge | Reproductive system and breast disorders | Non-systematic Assessment | A disorder characterized by vaginal secretions. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years. |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D007093 | Imidazoles |