Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer (CALOR)
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|ClinicalTrials.gov Identifier: NCT00074152|
Recruitment Status : Completed
First Posted : December 11, 2003
Results First Posted : May 12, 2015
Last Update Posted : June 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: chemotherapy Radiation: radiation therapy||Phase 3|
- Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer.
- 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 (QOL portion closed 11/13/08).
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 (QOL portion closed 11/13/08).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 22, 2016|
Active Comparator: Arm I
Patients receive radiotherapy* within 6 months after surgery.
Radiation: radiation therapy
Given within 6 months after surgery
Experimental: Arm II
Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.
Given within 10 weeks after surgery.
- Disease-free Survival [ Time Frame: 5 years after randomization ]
- Overall Survival [ Time Frame: 5 years after randomization ]
- Sites of First Failures [ Time Frame: 5 years after randomization ]Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074152
|Study Chair:||Stefan Aebi, MD||Inselspital Bern, Switzerland|
|Study Chair:||Irene L. Wapnir, MD||Stanford Cancer Center, CA, USA|