At a glance
ClinicalIndex Comparison Record- ✓Known HER-2/neu positive breast cancer (by immunohistochemistry; if intermediate, FISH required)
- ✓Histologically confirmed, operable breast cancer that is either ER/PR positive and HER-2/neu positive, or ER/PR negative
- ✓Radiographically measurable breast cancer >1 cm (T1c-T3, N0-N2a); core needle biopsy confirmation required
- ✓Chemotherapy naive
- ✕Primary tumor ≤1 cm or not measurable; inflammatory disease
- ✕Evidence of distant metastatic disease
- ✕Prior chemotherapy or hormonal therapy for breast cancer
- ✕Prior severe reaction to fluoropyrimidine therapy or known sensitivity to 5-fluorouracil
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating doxorubicin hydrochloride, cyclophosphamide, and 12 other interventions for Estrogen Receptor-negative Breast Cancer and 8 related conditions. Completed, enrolled 50 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
Given IV
Given PO
Given IV
Given SC
Given PO
Given IV
Given IV
Correlative studies
Undergo definitive breast surgery
Correlative studies
Given IV
Given PO
Given PO
Correlative studies