Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and its effectiveness in treating women who have locally advanced or metastatic breast cancer that was previously treated with combination chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody HuHMFG1 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
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