Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of...

Detailed Description

Treatment with letrozole begins within 21 days of registration, and only after notification has been received from the UCSF Breast MRI Research Laboratory that the baseline MRI is acceptable. Protocol...

Eligibility Criteria

Inclusion

  • Eligibility Criteria:
  • Histologic documentation: Pathologic confirmation of ductal carcinoma in situ (DCIS) of the female breast without invasive cancer, with diagnosis rendered on core biopsy only, completed within 60 days before registration. Patients diagnosed with DCIS on the basis of surgical biopsy are not eligible for this study.
  • Patients with microinvasion on diagnostic core biopsy, defined as tumor ≤ 1 mm in greatest dimension, will be allowed to participate.
  • All patients must have a clip placed, either at the time of the diagnostic biopsy or at the time of the baseline MRI prior to the start of treatment.
  • Tissue samples: Patient has diagnostic tissue available for correlative studies.
  • Clinical stage: Tis or T1mi N0, M0
  • Hormone receptor status: DCIS must express estrogen and/or progesterone receptor, as determined by immunohistochemical methods on the diagnostic pathology sample, according to the local institution's standard protocol. Greater than or equal to 1% cells will be considered to be positive.
  • Menopausal status: Patients must be postmenopausal defined as:
  • Age ≥ 55 years and one year or more of amenorrhea
  • Age \< 55 years and one year or more amenorrhea, with an estradiol assay \< 20pg/ml
  • Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)
  • The use of GnRH analogs to achieve post menopausal status is not allowed.
  • Prior treatment:
  • No prior surgical excision in the index breast for current DCIS diagnosis of DCIS
  • Any exogenous hormone therapy must be completed 4 weeks prior to registration
  • Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible
  • No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis
  • Contraindication to MRI: No contraindications to breast MRI
  • Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion ≥ 1 cm and ≤ 7 cm
  • DCIS must be visible on MRI based on central review.
  • Patients with palpable DCIS or adenopathy are not eligible to participate.
  • Patients with multifocal or bilateral disease are eligible.
  • History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.
  • Age: Patients ≥ 18 years of age
  • Performance Status: ECOG performance status 0 or 1
  • Pregnancy/nursing status: Not pregnant or nursing
  • Required Initial Laboratory Values:
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL
  • Serum creatinine ≤ 1.7 mg/dL
  • Bilirubin ≤ 2.0 mg/dL
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Serum estradiol level assay \< 20 pg/mL \*Required for patients \< 55 years of age and one year or more of amenorrhea

Exclusion

    Key Trial Info

    Start Date :

    February 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2018

    Estimated Enrollment :

    108 Patients enrolled

    Trial Details

    Trial ID

    NCT01439711

    Start Date

    February 1 2012

    End Date

    January 1 2018

    Last Update

    March 27 2018

    Active Locations (32)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (32 locations)

    1

    Cedars Sinai Medical Center

    Los Angeles, California, United States, 90048

    2

    Bay Area Tumor Institute

    Oakland, California, United States, 94609

    3

    UCSF Medical Center-Mount Zion

    San Francisco, California, United States, 94115

    4

    Exempla Saint Joseph Hospital

    Denver, Colorado, United States, 80218