Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Estrogen can stimulate
      the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by
      reducing the production of estrogen. It is not yet known whether giving more than one drug
      (combination chemotherapy) or giving letrozole before surgery is more effective in treating
      women with breast cancer.

      PURPOSE: This randomized phase III trial is studying giving combination chemotherapy before
      surgery to see how well it works compared with letrozole given before surgery in treating
      postmenopausal women with breast cancer that can be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase
           inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal
           women.

        -  To identify biological predictors of response to these two treatment modalities.

      OUTLINE: This is a multicenter pilot, feasibility study followed by a randomized study. In
      the pilot study, a record of all patients screened and invited to participate in the study is
      compiled. Reasons for failure to recruit will be recorded. Patients are randomized to 1 of 2
      treatment arms.

        -  Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day
           1. Treatment repeats every 21 days for 6 courses in the absence of disease progression
           or unacceptable toxicity. Patients who do not achieve at least partial response after 3
           courses receive docetaxel IV on day 1 of 3-week courses for an additional 3 courses.

        -  Arm II: Patients receive oral letrozole daily for 18-23 weeks until day of surgery.

      Patients in both arms undergo surgery at week 18-23. Most patients then receive adjuvant
      therapy.

      Quality of life is assessed at baseline, periodically during study treatment, and then during
      follow up.

      Blood is collected pre-treatment, at mid-treatment, and before surgery. Blood is then
      collected every 6 months for 2 years. Blood samples and preserved tumor samples are used for
      correlative studies.

      After completion of surgery, patients are followed up at least annually for 10 years.

      PROJECTED ACCRUAL: A total of 40 patients for the pilot study and 716 patients for the phase
      III study will be accrued.
    

Intervention name(s): cyclophosphamide; docetaxel; epirubicin hydrochloride; fluorouracil; letrozole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Given IV; Given IV; Given IV; Given IV; Given orally
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Fluorouracil; Letrozole; Epirubicin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: estrogen receptor-positive breast cancer; recurrent breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer