Clinical trial · Interventional
A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)
A Study to Establish Proof-of-Biology for MK-0646 in Breast Cancer
NCT00759785CI-TRIAL-00034374completedPhase 1Results postedClinicalTrials.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)
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.
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 |
|---|---|---|---|
| dalotuzumab (MK0646) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ER-positive Luminal B
- description
- Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.
- interventionNames
- Drug: dalotuzumab (MK0646)
- type
- EXPERIMENTAL
- label
- Triple Negative
- description
- Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.
- interventionNames
- Drug: dalotuzumab (MK0646)
Primary outcomes (1)
- measure
- Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)
- timeFrame
- Up to 12 Days Post-dose
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam * Participant is female and ≥18 years of age Exclusion Criteria: * Participant is pregnant, breastfeeding or planning to become pregnant while in the study * Participant has received prior chemotherapy, biological therapy or radiation * Participant has participated in a clinical trial in the last 30 days * Participant has a history of drug or alcohol abuse in the last year * Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C * Participant has poorly controlled diabetes mellitus
References
Publications (0)
Data not yet available
No reference posted for this study.