|
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer Clinical research trials and Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer clinical trial. Human subjects often get the best healthcare possible for their Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer  Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
For Condition: stage 1 breast cancer,recurrent breast cancer,stage 3C breast cancer,stage 3B breast cancer,stage 2 breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): International Breast Cancer Study Group ,
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regionalrelapsed breast cancer.
Details: OBJECTIVES: Primary - Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary - Determine the systemic disease-free and overall survival of patients treated with this regimen. - Determine the sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer in patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs regional lymph nodes). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive radiotherapy* within 6 months after surgery. - Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients also receive radiotherapy* within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. NOTE: *Patients with clear margins (R0) who received prior adjuvant radiotherapy are not required to receive further radiotherapy Patients with ER and/or PR positive tumors also receive standard hormonal therapy. Quality of life is assessed at baseline and at 9 and 12 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 978 patients (489 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or breast-conserving surgery - No other prior recurrence in any site, including local - Surgical resection of the recurrence meeting 1 of the following criteria: - Uninvolved ("clear") margins and planned radiotherapy with at least 50 Gy for patients who had no prior adjuvant radiotherapy - Microscopically involved margins and planned radiotherapy of at least 50 Gy - 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 - 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 - No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan - Hormone receptor status: - Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay - Estrogen receptor positive or negative - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StefanAebi, , Inselspital, Bern
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Stefan Aebi 41-031-632-41-14
Additional Information:
Study ID Numbers: CDR0000343619; BIG-1-02,IBCSG-27-02,EU-20320
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074152
Other Recurrent Breast Cancer Studies:
1. Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
2. Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
3. Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
4. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
5. Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Clinical Trials
Other Bern Clinical Trials
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
|
|
|
|
|
|
|
|
