Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Recurrence
Intervention: Exemestane; Docetaxel; Cytoxan
Intervention description: 25 mg daily by mouth for 6 to 12 months.; Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).; Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast, Male; Breast, Female

Summary:

      The patients are being asked to take part in this study because they have a hormone
      receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their
      doctor has told them that they have an option to receive chemotherapy or hormonal therapy
      before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and
      cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor
      and allow them to preserve the breast or have less extensive surgery on their breast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Histologically or cytologically confirmed breast carcinoma.

          -  Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], CM0).

          -  Pre-treatment biopsy with the following characteristics:

               -  Hormone receptor-positive cancer as defined as ER and/or progesterone receptor
                  (PR)-positive by standard immunohistochemistry (IHC)

               -  HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be fluorescent in situ
                  hybridization [FISH] non-amplified)

               -  Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay

          -  Patients must have measurable disease as defined by palpable lesion with both
             diameters ≥ 1 cm measurable with caliper or a positive mammogram or ultrasound with at
             least one dimension ≥ 1 cm. Screening mammogram of the contralateral breast must be
             performed within past 12 months per standard practice guidelines. Clip placement is
             required for study entry.

          -  Baseline measurements of the indicator lesions must be recorded on the Patient
             Registration Form. To be valid for baseline, the measurements must have been made
             within 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI
             must be done within 14 days. If palpable, a diagnostic mammogram of the affected
             breast or MRI must be done within 2 months prior to study enrollment, defined as date
             of signed, informed consent. If clinically indicated, staging xrays and scans must be
             done within 28 days of study entry.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

          -  Adequate organ function within 14 days of study entry:

               -  Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mm³, Hgb > 8.0 g/dl
                  and platelet count ≥ 100,000/mm³.

               -  Hepatic function: total bilirubin < upper limit of normal (ULN). Serum glutamic
                  oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase
                  (SGPT) (ALT) and alkaline phosphatase ≤ 1.5 x ULN).

               -  Renal function: calculated creatinine clearance (CrCl) ≥ 30 mL/min using the
                  Cockcroft Gault equation.

          -  Patients must be at least 18 years of age.

        Exclusion Criteria:

          -  Evidence of disease outside the breast or chest wall, except ipsilateral axillary or
             internal mammary lymph nodes.

          -  Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast
             cancer.

          -  Pregnant or lactating women are not eligible. Women of childbearing potential must
             have a negative serum pregnancy test completed within 7 days of study entry, and use
             an appropriate form of birth control throughout the trial period.

          -  Medical, psychological or surgical condition which the investigator feels might
             compromise study participation.

          -  Patients with history within the last 5 years of previous or current malignancy at
             other sites with the exception of adequately treated carcinoma in-situ of the cervix
             or basal or squamous cell carcinoma of the skin. Patients with a history of other
             malignancies who remain disease free for greater than five years are eligible.

          -  Evidence of peripheral or sensory neuropathy.

          -  Patients with a history of severe hypersensitivity reaction to docetaxel or other
             drugs formulated with polysorbate 80 are excluded from participation.

          -  Serious, uncontrolled, concurrent infection(s).

          -  Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
             coronary artery disease and cardiac arrhythmias not well controlled with medication)
             or myocardial infarction within the last 12 months prior to study entry.

          -  Major surgery within 28 days of study entry.

          -  Evidence of central nervous system (CNS) metastases.