Robert Carlson
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed breast cancer.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Procedure: adjuvant therapy
- Procedure: chemotherapy
- Procedure: radiation therapy
Phase:
Phase 3Eligibility
Ages Eligible for Study:
Any Age to Any AgeGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
o First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins
a. Local failure is defined as a tumor recurrence in any soft tissue of the ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin
b. Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammary. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast
o No other prior recurrence in any site, including local
- Surgical resection of the recurrence meeting 1 of the following criteria:
o Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for patients who had no prior adjuvant radiotherapy
o Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary
- No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes, by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically indicated (e.g., bone pain)
- No macroscopically incomplete surgery
- No bilateral malignancy except carcinoma in situ
- No suspicious mass in the opposite breast unless that mass has been proven by biopsy to be benign
- No skeletal pain of unknown cause
o No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan
- Hormone receptor status:
o Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay
o Estrogen receptor positive or negative
o Progesterone receptor positive or negative
PATIENT CHARACTERISTICS:
Age
- Any age
Sex
- Female
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- No elevated alkaline phosphatase
Renal
- Not specified
Other
- Fertile patients must use effective non-hormonal contraception
- Medically suitable for chemotherapy of 3-6 months duration
- No other primary malignant tumors except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- No non-malignant systemic disease that would preclude study treatment or prolong follow-up
- No psychiatric or addictive disorder that would preclude giving informed consent
- No history of noncompliance to medical regimens or potential for being unreliable
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast CancerAnticipated start date:
2/8/2005Lead Sponsor:
National Surgical Adjuvant Breast and Bowel Project (NSABP)Collaborator(s):
- International Breast Cancer Study Group
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Disease-free survival
Secondary Outcomes:
- Overall survival
- Systemic disease-free survival
- Quality of life as assessed by linear analog self assessment at baseline and 9 and 12 months
- Sites of first recurrence
- Secondary (non-breast) malignancies
- Causes of death without relapse of breast cancer
Total Number to be Enrolled:
977Total Number to be Enrolled at Stanford:
25More Information
Secondary ID(s):
- 95760
- BIG-1-02
- EU-20320
- EUDRACT-2005-001484-64
- IBCSG-27-02
- NCT00074152
- NSABP-B-37
- NSABPB37
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/5/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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