Clinical trial · Interventional
A Study of Pertuzumab in Participants With Metastatic Breast Cancer
Open-Label, Phase II, Multicenter, Randomized Study of Efficacy and Safety for Two Different Doses of a Recombinant Humanized Antibody to HER2 (rhuMAb 2C4) Administered Every 3 Weeks to Patients With Metastatic Breast Cancer With Low Expression of HER2
- 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)
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.
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 |
|---|---|---|---|
| Pertuzumab | Drug | Pertuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pertuzumab 1050 mg
- description
- Participants will not receive a loading dose, but will receive pertuzumab 1050 milligrams (mg) via intravenous (IV) infusion every 3 weeks until unacceptable toxicity or disease progression.
- interventionNames
- Drug: Pertuzumab
- type
- EXPERIMENTAL
- label
- Pertuzumab 420 mg
- description
- Participants will receive a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
- interventionNames
- Drug: Pertuzumab
Primary outcomes (1)
- measure
- Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available