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: 17.0Level: 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-IT
• 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: 2014-05-13
• Last Update Posted: 17 August 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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 367

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
- History of non-breast malignancies within 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- 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