Status:
COMPLETED
Preoperative Cisplatin in Early Stage Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effects the preoperative therapy cisplatin will have on patients with early stage estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), ...
Detailed Description
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 intraven...
Eligibility Criteria
Inclusion
- All tumors must be ER-, PR- and HER-2 negative.
- Age \> 18 years
- ECOG performance status of less than or equal to 1
- Absolute neutrophil count (ANC) \> 1,500/mm3
- Hemoglobin \> 9mm/dl
- Platelets \> 100,000/mm3
- Creatinine \< 1.5mg/dl
- Glucose \< 200mg/dl
- Bilirubin \< 1.5 x upper limit of normal (ULN)
- SGOT \< 3.0 x ULN
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00148694
Start Date
July 1 2004
End Date
May 1 2010
Last Update
August 31 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115