Phase 2
Completed N=79
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT02491892 ↗Enrolled (actual)
79
Serious AEs
23.1%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) — 4.9; 0 percentage of participants
Summary
This study will evaluate the efficacy and safety of pertuzumab (rhuMAb 2C4) in participants with metastatic breast cancer which has progressed during or after standard chemotherapy and which is not amenable to curative therapy. Those who are maintaining a response to therapy or who have stable disease at the end of the formal study period will continue treatment until disease progression or unacceptable toxicity. Approximately 120 participants will be enrolled.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) |
4.9; 0 | — |
| SECONDARY Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR |
12.1; NA | — |
| SECONDARY Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR |
24.6; NA | — |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of Confirmed CR |
0; 0 | — |
| SECONDARY Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR |
NA; NA | — |
| SECONDARY Number of Participants Who Experienced PD or Death |
38; 36 | — |
| SECONDARY Time to Progression |
6.1; 6.1 | — |
| SECONDARY Number of Participants Who Experienced PD or Withdrew From the Study Early |
41; 37 | — |
| SECONDARY Time to Treatment Failure |
6.3; 6.0 | — |
| SECONDARY Percentage of Participants Who Died |
46; 32 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of SD |
43.9; 37.8 | — |
| SECONDARY Apparent Half-Life (t1/2) of Pertuzumab |
12.2; 11.4 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Pertuzumab |
289; 409 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Pertuzumab |
0.073; 0.073 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) of Pertuzumab |
2517; 3465; 3598; 4750 | — |
| SECONDARY Systemic Clearance (CL) of Pertuzumab |
270; 247 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of Pertuzumab |
4122; 3527 | — |
| SECONDARY Mean Residence Time (MRT) of Pertuzumab |
16; 15 | — |
| SECONDARY Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50% |
3; 5; 3; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Females at least 18 years of age
- Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Karnofsky performance status at least 80%
- Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
- Left ventricular ejection fraction (LVEF) at least 50%
- Adequate liver function
Exclusion Criteria
- Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
- Pulmonary or central nervous system (CNS) metastases
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
- Previous treatment with any drug that targets the HER2 receptor family
- Previous treatment with corticosteroids as cancer therapy
- History of significant cardiac disease
- Major surgery or trauma within 4 weeks of Day 1
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02491892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.