Clinical trial · Interventional
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
- 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 CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| figitumumab | Biological | — | UNRESOLVED |
| imaging biomarker analysis | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
Secondary outcomes (5)
- measure
- Safety, tolerability and human anti-human antibodies (HAHA) response
- measure
- Tissue markers
- measure
- Measure of tumor glucose levels
- measure
- Pathological response
- measure
- Tumor size by MRI
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed early operable adenocarcinoma of the breast * No evidence of invasive lobular breast disease * Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI * Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy * Must have available or scheduled core breast biopsy procedure * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status 0-1 * Platelet count ≥ 100,000/mm\^³ * Neutrophil count ≥ 1,500/mm³ * Creatinine \< 1.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * ALT and AST \< 2.5 times ULN * Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment * Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures * No known hypersensitivity to monoclonal antibodies * No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin * No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment * No significant active cardiac disease including any of the following: * Uncontrolled high blood pressure (i.e., systolic blood pressure \[BP\] \> 160 mm Hg and diastolic BP \> 95 mm Hg) * Unstable angina * Deep venous thrombosis * Pulmonary embolism * Cerebrovascular attack * Valvular disease * Congestive heart failure * Myocardial infarction with the past 6 months * Serious cardiac arrhythmias * No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior surgery and recovered * More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or \> 40 mg dexamethasone per day) * No prior anti-IGF-1R based investigational therapy * No prior systemic therapy for primary disease * No concurrent chronic systemic high-dose immunosuppressive steroid therapy * Low-dose steroids for nausea and vomiting control allowed * Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed * No concurrent other anticancer drugs or therapy
References
Publications (0)
Data not yet available