Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2013
• 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: Terminated
• 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
• Affiliation: Inselspital Bern, Switzerland

• Name: Irene L. Wapnir, MD
• 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)