Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
Condition: Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: exemestane; triptorelin pamoate; capecitabine; methotrexate; vinorelbine tartrate; paclitaxel; therapeutic conventional surgery; radiation therapy; laboratory biomarker analysis
Intervention description: Given PO; Given IM; Given PO; Given IV; Given IV; Given IV; Undergo lumpectomy or mastectomy; Undergo radiation therapy; Correlative studies
Intervention MeSH terms: Paclitaxel; Vinorelbine; Capecitabine; Methotrexate; Exemestane; Triptorelin Pamoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving hormone therapy together with combination
      chemotherapy before and after surgery works in treating patients with stage I-IIIA breast
      cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using
      exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen
      the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine
      ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving hormone therapy together with
      combination chemotherapy before surgery may make the tumor smaller and reduce the amount of
      normal tissue that needs to be removed. Giving these treatments after surgery may kill any
      tumor cells that remain after surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically confirmed, operable ER or PR +, HER2/neu negative,
             radiographically measurable breast cancer > 1cm (Operable lesions are T1c - T3 and N0
             - N2a; histologic confirmation should be by core needle biopsy only)

          -  Be chemotherapy naive

          -  Have an ECOG performance status of =< 2

          -  Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a
             prior documented bilateral oophorectomy, or a history of at least 12 months without
             spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without
             oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy [or
             in whom the status of the ovaries is unknown], with a documented FSH level
             demonstrating confirmatory elevation in the postmenopausal range for the lab)

          -  All premenopausal patients must have a baseline FSH and LH

          -  ANC >= 1,500

          -  Platelet count >= 100,000

          -  Serum creatinine =< 1.5 x IULN

          -  Estimated creatinine clearance > 50 ml/min

          -  Have staging studies and tumor assessment prior to registration

          -  Bone density exam must be done within the first 3 months of complete hormonal blockade

          -  Have a negative pregnancy test within seven days prior to registration if of
             childbearing potential

          -  Be informed of the investigational nature of this study and provide written informed
             consent in accordance with institutional and federal guidelines prior to study
             specific screening procedures

        Exclusion Criteria:

          -  Primary tumor =< 1 cm, not measurable; inflammatory disease

          -  Pregnant or lactating; women of childbearing potential with either a positive or no
             pregnancy test at baseline are excluded (Women of childbearing potential who are not
             using a reliable and appropriate contraceptive method are excluded; patients must
             agree to continue contraception for 30 days from the last study drug administration)

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
             to 5-fluorouracil

          -  Previous enrollment in an investigational drug study within the last 4 weeks

          -  Evidence of distant metastatic disease

          -  Prior chemotherapy or hormonal therapy for breast cancer

          -  Prior malignancy other than adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, other stage I or II cancer from which the patient has
             been disease free for at least 5 years

          -  History of uncontrolled seizures, central nervous system disorders, or psychiatric
             disability judged by the investigator to be clinically significant, precluding
             informed consent, or interfering with compliance with oral drug intake

          -  Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or
             clinically significant cardiac disease - congestive heart failure, symptomatic
             coronary artery disease, cardiac arrhythmia not well controlled with medication or
             myocardial infarction

          -  Major surgery within four weeks of the start of study treatment without complete
             recovery

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  Known, existing uncontrolled coagulopathy

          -  Unwillingness to give informed consent

          -  Unwillingness to participate or inability to comply with the protocol for the duration
             of the study