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Protocol No. UW16112
Principal Investigator Wisinski, Kari
Age Group Adult
Sponsor Type Institutional
Title A Phase II Study of Neoadjuvant Weekly Carboplatin/Paclitaxel followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients with Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer
Objective This study looks at what effects treatment with a specific drug combination before surgery will have on triple negative breast cancer. Previous research has shown that people whose treatment included adding Carboplatin to Doxorubicin/Cyclophosphamide plus Paclitaxel (AC-T) had better responses to treatment than patients treated with AC-T alone. However, people treated with the combination, including Carboplatin, had more side effects, which caused the delaying of treatment, increased the amount of time on treatment, or caused them to stop treatment earlier. The purpose of this study is to see what effect(s) treatment with a lower dose of Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide, as compared to those previous studies, would have on subjects, including whether subjects will experience fewer side effects and have fewer treatment delays.
Treatment The drug combination used in this study will include the drugs Carboplatin and Paclitaxel, followed by treatment with Doxorubicin, Cyclophosphamide and Pegfilgrastim or Filgrastim.
Description Carboplatin and Paclitaxel will be given on days 1,8 and 15 curing cycles 1-4. Cycles 1-4 are 3 weeks long. Doxorubicin and Cyclophosphamide will be given on day 1, every 2 weeks for cycles 5-8. Cycles 5-8 are 2 weeks long. Filgratim/Pegfilgrastim or a similar drug will be given on day 2 or day 3 every 2 weeks for cycles 5-8, if you need it.
- Subjects must have histologically or cytologically confirmed invasive breast cancer that is Estrogen Receptor and Progesterone Receptor negative, HER-2-negative and tumor size of at least 2.1 cm
- Subjects with inflammatory breast cancer are eligible
- Candidate for neoadjuvant chemotherapy
- Age > 18 years
- Non Pregnant
- Patients with prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration are ineligible
- Patients with prior investigational drugs for invasive breast cancer within 6 months before registration are ineligible
- Patients with Stage IV metastatic breast cancer are ineligible
- Breastfeeding women are ineligible
- Patients with other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer are ineligible
Applicable Disease Sites Breast
Therapies Involved Cytotoxic Chemotherapy
Drugs Involved adr (doxorubicin); adria (doxorubicin); adriamycin (doxorubicin); carboplatin; cbdca (carboplatin); cpm (cyclophosphamide); ctx (cyclophosphamide); cyclophosphamide; cytoxan (cyclophosphamide); dox (doxorubicin); doxorubicin; neosar (cyclophosphamide); paclitaxel; paraplatin (carboplatin); taxol (paclitaxel)
Participating Institutions UW Hospital and Clinics; Wisconsin Medical College