Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
|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||Drug: exemestane Drug: triptorelin pamoate Drug: capecitabine Drug: methotrexate Drug: vinorelbine tartrate Drug: paclitaxel Procedure: therapeutic conventional surgery Radiation: radiation therapy Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Complete Hormonal Blockade Followed by Neoadjuvant Chemotherapy for Resectable Hormone Receptor Positive, HER-2/Neu Negative Breast Cancer, A Phase II Study|
- Number of Participants With Clinical Response [ Time Frame: 1 month ]Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease.
- Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response [ Time Frame: From date of treatment start to surgery ]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.
- Disease-free Survival [ Time Frame: Up to 5 years ]Kaplan-Meier estimate assessed at 5 years
- Overall Survival [ Time Frame: Up to 5 years ]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.
- Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities [ Time Frame: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery) ]Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities
- Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation [ Time Frame: During adjuvant and neoadjuvant chemotherapy ]Count of patients with dose reduction, treatment interruption, or treatment discontinuation.
- Correlation of Molecular Markers With Response, Time to Progression, and Survival [ Time Frame: Weekly during CHB and XMN and pacitaxel ]
|Study Start Date:||August 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (hormone therapy and chemotherapy)
See detailed description
Other Names:Drug: triptorelin pamoate
Other Names:Drug: capecitabine
Other Names:Drug: methotrexate
Other Names:Drug: vinorelbine tartrate
Other Names:Drug: paclitaxel
Other Names:Procedure: therapeutic conventional surgery
Undergo lumpectomy or mastectomyRadiation: radiation therapy
Undergo radiation therapy
Other Names:Other: laboratory biomarker analysis
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00194792
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Hannah Linden||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|