Letrozole in Treating Postmenopausal Women with Ductal Carcinoma in Situ
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 12-002183
NCT ID: NCT01439711
Sponsor Protocol Number: CALGB-40903
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See 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 Tlmi 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Tina Hieken, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office