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
PRIMARY OBJECTIVES: I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of complete hormonal blockade (CHB) for 2 weeks followed by four three-week cycles of Xeloda, Methotrexate and Navelbine with continuation of complete hormonal blockade. SECONDARY OBJECTIVES: I. To assess the clinical response rate in patients with surgically resectable breast cancer treated with complete hormonal blockade and four three-week cycles of Xeloda, Methotrexate and Navelbine. II. To assess the toxicity associated with these regimens. III. To assess the relapse rate, overall and disease-free survival in patients with operable breast cancer when treated with neoadjuvant CHB and XMN + CHB followed by adjuvant treatment using XMN or Taxol. IV. To assess whether the phenotype of breast cancer changes with treatment. V. To assess whether phenotypic changes in breast tumors predict outcome. OUTLINE: NEOADJUVANT CHB: Patients receive exemestane orally (PO) daily for 14 weeks. Premenopausal patients also receive triptorelin pamoate intramuscularly (IM) once monthly for 4 months beginning 2 weeks before the initiation of exemestane. NEOADJUVANT CHEMOTHERAPY: Patients receive capecitabine PO twice daily (BID) on days 1-14 and methotrexate intravenously (IV) and vinorelbine ditartrate IV over 6-10 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses. SURGERY: Patients then undergo definitive surgical resection with or without radiation therapy. ADJUVANT CHEMOTHERAPY: Patients with microscopic complete response (pCR) or disease that has been down-staged to =\< 1 cm with no positive nodes receive capecitabine PO BID on days 1-14 and methotrexate IV and vinorelbine ditartrate IV over 6-10 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses. Patients with down-staged T and 0 or 1 positive node receive paclitaxel IV over 1 hour once weekly for 12 weeks. ADJUVANT HORMONAL THERAPY: Patients receive hormonal therapy for 5 years. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given PO
Given IM
Given PO
Given IV
Given IV
Given IV
Undergo lumpectomy or mastectomy
Undergo radiation therapy
Correlative studies
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Number of Participants With Clinical Response
Defined as a \> 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
Time frame: 1 month
Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen.
Time frame: From date of treatment start to surgery
Disease-free Survival
Kaplan-Meier estimate assessed at 5 years
Time frame: Up to 5 years
Overall Survival
From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years.
Time frame: Up to 5 years
Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
Time frame: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)
Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
Count of patients with dose reduction, treatment interruption, or treatment discontinuation.
Time frame: During adjuvant and neoadjuvant chemotherapy
Correlation of Molecular Markers With Response, Time to Progression, and Survival
Time frame: Weekly during CHB and XMN and pacitaxel
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