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NCT00856050 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2017-04-18

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival Rate at 12 Weeks

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    single arm trial - all patients received letrozole 2.5mg by mouth per day
    intervention Names
    1. Drug: letrozole
    label
    letrozole
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. letrozole
    description
    Taken orally once a day continuously
    name
    letrozole
    other Names
    1. Femara
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
27
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Data below are reported as progression free rate (%).
    measure
    Progression Free Survival Rate at 12 Weeks
    time Frame
    12 weeks
Full study description
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).
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
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
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      source kind
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      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      payload sha256
      a0f6d48f4c9aef31fdd3dddf2e0a114909353396a2650af6150e40fdfcc7f526
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-6f162cc31780d5aad8b4
      link basis
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT00856050
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2605c44750067954f15861c9a03fb081f5b884735dcdfb413ec245015deb5050

    Preserved source evidence · Not medical advice