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Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856050
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : March 19, 2014
Last Update Posted : April 18, 2017
Brigham and Women's Hospital
Information provided by (Responsible Party):
Suzanne George, MD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).

Condition or disease Intervention/treatment Phase
Leiomyosarcoma Drug: letrozole Phase 2

Detailed Description:
  • Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
  • Visit 1 (Day 1): physical examination, vital signs and blood work
  • Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
  • Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
  • Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Study Start Date : February 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: letrozole
single arm trial - all patients received letrozole 2.5mg by mouth per day
Drug: letrozole
Taken orally once a day continuously
Other Name: Femara

Primary Outcome Measures :
  1. Progression Free Survival Rate at 12 Weeks [ Time Frame: 12 weeks ]
    Data below are reported as progression free rate (%).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective
  • Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range
  • Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue
  • Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment
  • 18 years of age or older
  • Life expectancy of 3 months or more
  • ECOG Performance Status 0, 1, or 2
  • No limit to number of prior chemotherapies or biologics
  • Normal organ function as outlined in the protocol
  • Resolution of clinically significant toxicities related to prior therapies

Exclusion Criteria:

  • Pre-menopausal women
  • Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
  • Palliative radiotherapy within 2 weeks of study entry
  • Major surgery within 2 weeks of study entry
  • Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)
  • Participants may not be receiving any other concomitant investigational agents
  • Uncontrolled brain or central nervous system metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00856050

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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Principal Investigator: Suzanne George, MD Dana-Farber Cancer Institute
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Responsible Party: Suzanne George, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00856050    
Other Study ID Numbers: 08-341
First Posted: March 5, 2009    Key Record Dates
Results First Posted: March 19, 2014
Last Update Posted: April 18, 2017
Last Verified: March 2017
Keywords provided by Suzanne George, MD, Dana-Farber Cancer Institute:
estrogen receptor positive
progesterone receptor positive
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs