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Clinical Trials (PDQ®)

Letrozole in Treating Postmenopausal Women With Ductal Carcinoma in Situ

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, TreatmentActive18 and overNCI, OtherCALGB-40903
CDR0000701992, U10CA037447, NCI-2011-03452, NCT01439711

Trial Description

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 estrogen the body makes.

PURPOSE: This phase II trial is studying how well letrozole works in treating women with ductal carcinoma in situ.

Further Study Information

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 therapy will consist of 6 months of letrozole, administered orally at a dose of 2.5 mg/day. Patients will have a MRI for disease evaluation at months 3 and 6. All patients will continue to take study drug until the day prior to surgery, whether at month 3 or at month 6 or may stop if they experience unacceptable toxicity. It is expected that decisions regarding any adjuvant treatment (eg, radiation and hormonal therapy) will be made individually based on the best practice guidelines, using informed and shared decision making between patient and provider. The primary and secondary objectives are provided below.

Primary objective:

1. To estimate the mean change in MRI tumor volume from pretreatment to completion of preoperative endocrine therapy in estrogen receptor-positive (ER+) ductal carcinoma in situ (DCIS), as well as to determine whether 3-month change in volume correlates with 6-month change.

Secondary objectives:

1. To assess radiographic-pathologic correlation between MRI findings and histopathology, including the prevalence of occult invasive cancer in patients undergoing neoadjuvant endocrine therapy for DCIS.

2. To compare changes in MRI maximum lesion diameter and mammographic extent at baseline and following treatment.

3. To determine practice patterns of adjuvant hormonal and radiation therapy in patients who complete neoadjuvant letrozole therapy for DCIS.

4. To determine whether Ki67 is reduced with neoadjuvant letrozole treatment for DCIS, and to compare the reduction in proliferation between radiographic responders and non-responders.

5. To identify baseline IHC and expression biomarkers predictive of response to treatment, with response determined by extent of Ki67 reduction.

6. To examine whether germline polymorphisms are associated with clinical endpoints, including treatment-related toxicity or efficacy outcomes, or with expression of biomarkers in serum or tumor.

7. To assess quality-of-life and musculoskeletal symptoms associated with neoadjuvant letrozole for ER+ DCIS.

Patients will be followed up to 6 months post-surgery.

Eligibility Criteria

Eligibility Criteria:

1. 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.

1. Patients with microinvasion on diagnostic core biopsy, defined as tumor ≤ 1 mm in greatest dimension, will be allowed to participate.

2. 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.

2. Tissue samples: Patient has diagnostic tissue available for correlative studies.

3. Clinical stage: Tis or Tlmi N0, M0

4. 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.

5. Menopausal status: Patients must be postmenopausal defined as:

1. Age ≥ 55 years and one year or more of amenorrhea

2. Age < 55 years and one year or more amenorrhea, with an estradiol assay < 20pg/ml

3. 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.

6. Prior treatment:

1. No prior surgical excision in the index breast for current DCIS diagnosis of DCIS

2. Any exogenous hormone therapy must be completed 4 weeks prior to registration

3. Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible

4. No prior neoadjuvant/adjuvant therapy for current DCIS diagnosis

7. Contraindication to MRI: No contraindications to breast MRI

8. Measurable disease: Mammographic extent of calcifications must be accurately measurable in at least one dimension with each lesion ≥ 1 cm and ≤ 7 cm

1. DCIS must be visible on MRI based on central review.

2. Patients with palpable DCIS or adenopathy are not eligible to participate.

3. Patients with multifocal or bilateral disease are eligible.

9. History of osteoporosis: Women diagnosed with osteoporosis may participate in this trial provided they are receiving appropriate therapy or if they have declined therapy.

10. Age: Patients ≥ 18 years of age

11. Performance Status: ECOG performance status 0 or 1

12. Pregnancy/nursing status: Not pregnant or nursing

13. Required Initial Laboratory Values:

1. ANC ≥ 1,000/μL

2. Platelet count ≥ 100,000/μL

3. Serum creatinine ≤ 1.7 mg/dL

4. Bilirubin ≤ 2.0 mg/dL

5. AST/ALT ≤ 2.5 times upper limit of normal

6. Serum estradiol level assay < 20 pg/mL

  • Required for patients < 55 years of age and one year or more of amenorrhea

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

E. Shelley HwangPrincipal Investigator

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Tina J Hieken Ph: 507-538-7623
California
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Armando E Giuliano Ph: 310-423-8965
  Oakland
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Laura J. Esserman Ph: 877-827-3222
Delaware
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
Iowa
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Alexandra Thomas Ph: 800-237-1225
Kentucky
  Lexington
 Central Baptist Hospital
 Peter S. Tate Ph: 859-260-6425
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Mehra Golshan Ph: 617-724-5200
 Mehra Golshan Ph: 617-724-5200
  Email: mgolshan@partners.org
  South Weymouth
 Dana-Farber/Brigham and Women's Cancer Center at South Shore
 Mehra Golshan Ph: 617-724-5200
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Tina J Hieken Ph: 507-538-7623
Missouri
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
North Carolina
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 David W Ollila Ph: 877-668-0683
  Email: cancerclinicaltrials@med.unc.edu
  Durham
 Duke Cancer Institute
 Jeffrey Crawford Ph: 888-275-3853
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
Ohio
  Columbus
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Wajeeha Razaq Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Ann Marilyn Leitch Ph: 214-648-7097
  Houston
 Univeristy of Texas M.D. Anderson Cancer Center
 Isabelle Bedrosian Ph: 713-792-3245
Virginia
  Hampton
 Sentara Cancer Institute at Sentara CarePlex Hospital
 Richard A Hoefer Ph: 757-827-2202
  Norfolk
 Sentara Cancer Institute at Sentara Norfolk General Hospital
 Richard A Hoefer Ph: 757-827-2202
 Sentara Leigh Hospital
 Richard A Hoefer Ph: 757-827-2202

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01439711
ClinicalTrials.gov processed this data on September 18, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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