Clinical trial · Interventional
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) 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)
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pertuzumab + Trastuzumab + Taxane
- description
- Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.
- interventionNames
- Drug: Docetaxel
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- Drug: Pertuzumab
- Drug: Trastuzumab
Primary outcomes (27)
- measure
- Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)
- timeFrame
- From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection * HER2-positive breast cancer * Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * LVEF of at least 50 percent (%) Exclusion Criteria: * Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease * Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months * Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy * Central nervous system (CNS) metastases * Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0) * History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma * Inadequate bone marrow, liver or renal function * Uncontrolled hypertension * Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
References
Publications (1)
- DERIVEDBachelot T, Ciruelos E, Schneeweiss A, Puglisi F, Peretz-Yablonski T, Bondarenko I, Paluch-Shimon S, Wardley A, Merot JL, du Toit Y, Easton V, Lindegger N, Miles D; PERUSE investigators. Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE). Ann Oncol. 2019 May 1;30(5):766-773. doi: 10.1093/annonc/mdz061. PMID 30796821