Clinical trial · Interventional
Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer
An Open Label Phase I Study of Humanized Human Milk Fat Globule-1 (huHMFG1) Antibody in Patients With Locally Advanced or Metastatic Breast Cancer (TOPCAT)
NCT00096057CI-TRIAL-00011100completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 such as HuHMFG1 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody HuHMFG1 in treating women with locally advanced or metastatic breast cancer.
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 * Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria) * Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy * Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®) * No known CNS metastases * No metastases accessible to complete surgical resection * Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available * Appropriate tumor block also acceptable * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * WHO 0-1 Life expectancy * At least 4 months Hematopoietic * Hemoglobin ≥ 10 g/dL * Absolute neutrophil count ≥ 1,500/mm\^3 * WBC ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * ALT or AST ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in patients with liver metastases) OR * Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN in patients with liver metastases) * Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance \> 60 mL/min * Uric acid \< 1.25 times ULN (for patients with hyperuricemia only) * Calcium (corrected for serum albumin) \< 11.5 mg/dL (for patients with hypercalcemia only) Cardiovascular * LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia * No other uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * Prior biological therapy allowed * More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery * No other concurrent antitumor immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior cytotoxic chemotherapy * No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy * No concurrent antitumor chemotherapy Endocrine therapy * Prior hormonal therapy allowed * No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions * No concurrent antitumor hormonal therapy Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy (except for palliative radiotherapy) * No concurrent antitumor radiotherapy, except for palliation to non-study lesions * Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period Surgery * More than 4 weeks since prior major surgery Other * More than 30 days since prior investigational agents * No other concurrent investigational agents
References
Publications (1)
- DERIVEDPegram MD, Borges VF, Ibrahim N, Fuloria J, Shapiro C, Perez S, Wang K, Schaedli Stark F, Courtenay Luck N. Phase I dose escalation pharmacokinetic assessment of intravenous humanized anti-MUC1 antibody AS1402 in patients with advanced breast cancer. Breast Cancer Res. 2009;11(5):R73. doi: 10.1186/bcr2409. PMID 19811637