Status:
COMPLETED
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
Lead Sponsor:
NSABP Foundation Inc
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment. PURPOSE: This clinical trial is studying how...
Detailed Description
OBJECTIVES: Primary * Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I, II, or IIIA breast cancer undergoing surgery and b...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Histologic diagnosis of invasive adenocarcinoma of the breast diagnosed by core, incisional, or excisional biopsy.
- All of the following staging criteria must be met: Primary tumor must be operable and staged as cT1-3 by clinical evaluation. Ipsilateral nodes must be cN0-1 by clinical evaluation. No evidence of metastatic disease (M0).
- Exclusion criteria:
- Patients with any history of breast malignancy including DCIS (patients with a history of Lobular Carcinoma in Situ (LCIS) are eligible).
- Treatment including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days after diagnosis and before study entry.
- Patients who will be receiving preoperative chemotherapy.
- Bilateral malignancy (including DCIS).
- Other non-breast malignancies unless the patient is considered disease-free for 5 years before study entry and is deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, colon carcinoma in situ, and basal cell and squamous cell carcinoma of the skin.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
1630 Patients enrolled
Trial Details
Trial ID
NCT00089323
Start Date
January 1 2007
End Date
August 1 2018
Last Update
October 11 2021
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
Morton Plant Hospital
Clearwater, Florida, United States, 33756