Preoperative Cisplatin in Early Stage Breast Cancer - Article Avinza; Kadian; MS Contin; Oramorph SR
Clinical Trial: Preoperative Cisplatin in Early Stage Breast Cancer
This study is currently recruiting patients.
Verified by Dana-Farber Cancer Institute September 2005
|Breast Cancer |
ER Negative Breast Cancer
PR Negative Breast Cancer
HER-2 Negative Breast Cancer
| Drug: Cisplatin ||Phase II |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Secondary Outcomes: To determine the pathologic complete response after preoperative therapy with cisplatin in this patient population.
Expected Total Enrollment: 27
Study start: October 2004
- Before starting treatment patients will undergo placement of a clip into the tumor bed so the surgeon can locate the site of the tumor at the time of surgery.
- Patients will receive cisplatin intravenously once every three weeks for a total of 4 cycles or 12 weeks of treatment.
- After completion of cisplatin, patients will undergo surgery to remove any tumor that remains and to assess the tissue to see if tumor cells remain in the breast.
- Patients may receive a second breast MRI and biopsy 7-14 days after treatment begins to see whether we can identify tumors that will ultimately respond to cisplatin with a rapid evaluation.
- Patients will receive study treatment for approximately 12 weeks unless unacceptable toxicity occurs. After surgery patients will receive standard adjuvant therapy based on discussion with their physician. Follow-up progress will occur for several years.
- All tumors must be ER-, PR- and HER-2 negative
- Age > 18 years
- ECOG performance status of less than or equal to 1
- ANC > 1,500/mm3
- Hemoglobin > 9mm/dl
- Platelets > 100,000/mm3
- Creatinine< 1.5mg/dl
- Glucose < 200mg/dl
- Bilirubin < 1.5 x ULN
- SGOT < 3.0 x ULN
- Prior chemotherapy treatment
- Pregnant or breast-feeding women
- History of serious illness, medical or psychiatric condition requiring medical management
- Uncontrolled infection
- Renal dysfunction
- Active or severe cardiovascular or pulmonary disease
- Peripheral neuropathy of any etiology that exceeds grade 1
- Prior history of malignancy
- Uncontrolled diabetes
Location and Contact Information
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
Massachusetts General Hospital, Boston, Massachusetts, 02115, United States; Recruiting
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States; Recruiting
Judy E. Garber, MD, Principal Investigator, Dana-Farber Cancer Institute
Last Updated: September 7, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00148694
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13