A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy as Neoadjuvant Therapy in Patients With HER2-Positive Early Breast Cancer

Phase 1

• Conditions: HER2-POSITIVE, LOCALLY ADVANCED, INFLAMMATORY, OR EARLY-STAGE BREAST CANCER; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000156-28-PL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

- Adult patients, = 18 years of age
- HER2-positive breast cancer confirmed by a central laboratory
- Primary tumor > 2 cm in diameter, or > 5 mm in diameter and node-positive
- Eastern Cooperative Oncology Group (ECOG) performance status =1
- Baseline LVEF = 55% (measured by ECHO or MUGA)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 367
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

- Any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
- Metastatic disease (Stage IV) or bilateral breast cancer
- Previous exposure to any investigational treatment within 4 weeks before the first dose of study treatment
- Prior breast or non-breast malignancy within 5 years prior to study
entry, except for carcinoma in situ and basal cell and squamous cell
carcinoma of the skin. Patients with malignancies occurring more than 5
years prior to study entry are permitted if curatively treated.
- Inadequate hematologic, renal or liver function
- Pregnant or lactating women
- History of congestive heart failure of any New York Heart Association (NYHA) criteria
- angina requiring anti-anginal medication
- history of myocardial infarction within 6 months of enrollment
- serious or uncontrolled cardiac arrhythmia requiring treatment
- History or evidence of poorly controlled hypertension
- Severe, uncontrolled systemic disease
- Positive for hepatitis B, hepatitis C or HIV infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified