Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00066547
• Date of registration: 06/08/2003
• Primary sponsor: Jonsson Comprehensive Cancer Center
• Public title: Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
• Scientific title: An Open Label Phase I/II Study of Humanized Human Milk Fat Globule-1 (THEREX) in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy
• Date of first enrolment: May 2003
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00066547
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mark D. Pegram, MD
• Affiliation: Jonsson Comprehensive Cancer Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed breast cancer

- Locally advanced or metastatic disease

- No inflammatory breast cancer

- Polymorphic epithelial mucin (PEM) antigen overexpression by immunohistochemistry

- Previously treated with an anthracycline and a taxane in any combination for breast
cancer

- No more than 2 prior chemotherapy regimens, including adjuvant /neoadjuvant
therapy

- No more than 1 prior regimen for distant metastatic disease

- Any number of prior hormonal or biologic therapy regimens allowed

- Measurable disease

- At least one unidimensionally measurable lesion not previously irradiated

- The following are not considered measurable lesions:

- Bone

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- No metastases accessible to complete surgical resection

- No CNS metastasis by CT scan

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- WHO 0-2

Life expectancy

- At least 4 months

Hematopoietic

- Hemoglobin at least 10 g/dL

- Neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- ALT and AST no greater than 2.5 times upper limit of normal (ULN) (less than 5 times
ULN if liver metastases are present)

Renal

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance greater than 60 mL/min

- No hyperuricemia (uric acid at least 1.25 times ULN)

- No hypercalcemia (calcium at least 11.5 mg/dL [corrected for serum albumin])

Cardiovascular

- LVEF at least 45% by MUGA or echocardiogram within the past 4 weeks

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3-6 months after
study participation

- No other prior malignancy within the past 5 years except adequately treated
nonmelanoma skin cancer or cervical intraepithelial neoplasia

- No other concurrent uncontrolled comorbid illness that represents unacceptable risk
in the opinion of the investigator

- No legal incapacity

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- More than 2 weeks since prior growth factors to aid hematologic recovery

- No other concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior cytotoxic chemotherapy

- No concurrent chemotherapy for metastatic breast cancer

Endocrine therapy

- See Disease Characteristics

- No concurrent endocrine therapy for metastatic breast cancer

- No concurrent chronic corticosteroid therapy

- No concurrent high-dose corticosteroids

Radiotherapy

- More than 4 weeks since prior radiotherapy except for palliation

- No concurrent antitumor radiotherapy except for palliation

Surgery

- More than 4 weeks since prior major surgery

Other

- More than 2 weeks since prior blood transfusions to aid hematologic recovery

- No participation in any other investigational drug study

- No other concurrent investigational drugs

- No other concurrent antitumor therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Biological: monoclonal antibody HuHMFG1

Secondary ID(s)

ANTISOMA-ASM-THEREX-01

ANTISOMA-TOPCAT

CDR0000316264

UCLA-0212097

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)