Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer (CALOR)
This study has been terminated.
(Insufficient accrual)
Sponsor:
International Breast Cancer Study Group
Collaborator:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00074152
First received: December 10, 2003
Last updated: April 3, 2013
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: chemotherapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer |
Resource links provided by NLM:
Further study details as provided by International Breast Cancer Study Group:
Primary Outcome Measures:
- Disease-free survival [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
- Systemic disease-free survival [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
- Quality of life as assessed by linear analog self assessment at baseline and 9 and 12 months (QOL portion closed 11/13/08) [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
- Sites of first recurrence [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
- Secondary (non-breast) malignancies [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
- Causes of death without relapse of breast cancer [ Time Frame: 10 years after randomization ] [ Designated as safety issue: No ]
| Enrollment: | 162 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: chemotherapy
Given within 10 weeks after surgery.
|
Detailed Description:
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 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 lumpectomy/quadrantectomy with clear surgical margins
- 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
- 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
- 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 40 Gy for patients who had no prior adjuvant radiotherapy
- Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary
- Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are allowed for patients with HER-2 positive tumors and must be declared prior to randomization
- 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
- 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
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074152
Show 199 Study Locations
Show 199 Study LocationsSponsors and Collaborators
International Breast Cancer Study Group
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
| Study Chair: | Stefan Aebi, MD | Inselspital Bern, Switzerland |
| Study Chair: | Irene L. Wapnir, MD | Stanford Cancer Center, CA, USA |
More Information
Additional Information:
Publications:
| Responsible Party: | International Breast Cancer Study Group |
| ClinicalTrials.gov Identifier: | NCT00074152 History of Changes |
| Other Study ID Numbers: | CDR0000343619, IBCSG-27-02, BIG-1-02, EU-20320, NSABP-B-37, 2005-001484-64 |
| Study First Received: | December 10, 2003 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Netherlands: Medicines Evaluation Board (MEB) Hungary: National Institute of Pharmacy Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by International Breast Cancer Study Group:
|
recurrent breast cancer stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013