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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 February 2014
Main ID:  NCT00074152
Date of registration: 10/12/2003
Primary sponsor: International Breast Cancer Study Group
Public title: Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer CALOR
Scientific title: A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Date of first enrolment: July 2002
Target sample size: 162
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00074152
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Australia Belgium Canada Hungary Netherlands Peru South Africa Spain
Switzerland United States
Contacts
Name:   Stefan Aebi, MD
Address: 
Telephone:
Email:
Affiliation:  Inselspital Bern, Switzerland
Name:   Irene L. Wapnir, MD
Address: 
Telephone:
Email:
Affiliation:  Stanford Cancer Center, CA, USA
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Breast Cancer
Intervention(s)
Drug: chemotherapy
Radiation: radiation therapy
Primary Outcome(s)
Disease-free survival [Time Frame: 10 years after randomization]
Secondary Outcome(s)
Causes of death without relapse of breast cancer [Time Frame: 10 years after randomization]
Overall survival [Time Frame: 10 years after randomization]
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]
Secondary (non-breast) malignancies [Time Frame: 10 years after randomization]
Sites of first recurrence [Time Frame: 10 years after randomization]
Systemic disease-free survival [Time Frame: 10 years after randomization]
Secondary ID(s)
2005-001484-64
BIG-1-02
CDR0000343619
EU-20320
IBCSG-27-02
NSABP-B-37
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
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