HER2-positive Breast Cancer Clinical Trial
Official title:
A Study of Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Resectable, Hormone Receptor Negative or Hormone Receptor Positive, HER-2/Neu Positive Breast Cancer Followed by a Novel Regimen of Capecitabine, Methotrexate and Vinorelbine for Patients Who Do Not Have Either a Macroscopic or Microscopic Pathologic Complete Response, a Phase II Study
This phase II trial studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 (HER2)-positive breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Colony-stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving doxorubicin hydrochloride, cyclophosphamide, and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer
PRIMARY OBJECTIVES:
I. To assess the pathologic response rate in patients with operable breast cancer treated
with a two part, neoadjuvant regimen consisting of weekly doxorubicin (doxorubicin
hydrochloride) and daily oral cyclophosphamide given with G-CSF (filgrastim) support for 12
weeks followed weekly paclitaxel for 12 weeks.
SECONDARY OBJECTIVES:
I. To assess the clinical response rate in patients with surgically resectable breast cancer
treated with weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for
12 weeks.
II. To assess the clinical response rate in patients with surgically resectable breast cancer
treated with weekly paclitaxel for 12 weeks.
III. To assess the relapse rate, overall and disease-free survival in patients with operable
breast cancer treated with neoadjuvant chemotherapy consisting of weekly doxorubicin and
daily oral cyclophosphamide given with G-CSF support for 12 weeks followed weekly paclitaxel
for 12 weeks and adjuvant chemotherapy with Xeloda (capecitabine), Methotrexate and Navelbine
(vinorelbine tartrate) (XMN).
IV. To assess the toxicity associated with these regimens. V. To assess whether the phenotype
of breast cancer changes with treatment. VI. To assess whether phenotypic changes in breast
tumors predict outcome.
OUTLINE:
PART I: Patients receive doxorubicin hydrochloride intravenously (IV) on day 1 of each week,
cyclophosphamide orally (PO) once daily (QD), and filgrastim subcutaneously (SC) QD on days
2-7 of each week. Treatment continues for 12 weeks in the absence of disease progression or
unacceptable toxicity.
PART II: Patients* receive paclitaxel IV over 1 hour on day 1 of each week. Treatment
continues for 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients then undergo definitive surgical resection by partial mastectomy (lumpectomy) or
mastectomy after completion of neoadjuvant chemotherapy.
PART III: Patients** unable to achieve complete pathologic response (pCR) or disease that has
been down-staged to =< 1 cm with no positive nodes following surgery receive capecitabine PO
twice daily (BID) on days 1-14, methotrexate IV on days 1, 8 and 15, and vinorelbine tartrate
IV over 6-10 minutes on days 1, 8, and 15. Treatment repeats every 3 weeks for 4 courses in
the absence of disease progression or unacceptable toxicity.
NOTE: *Patients with HER2/neu-positive disease also receive trastuzumab IV over 30-90 minutes
once weekly or every 3 weeks for 1 year beginning in Part II.
NOTE: **Patients with hormone receptor-positive disease also receive tamoxifen PO QD for 5
years (premenopausal) OR letozole PO QD or tamoxifen PO QD for 5 years (postmenopausal)
beginning in Part III.
After completion of study treatment, patients are followed up every 3 months for 3 years,
every 6 months for 2 years, and then annually thereafter.
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