A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab; Drug: Herceptin; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545688

WO20697

Details and patient eligibility

About

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 417 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients, >=18 years of age;
• locally advanced, inflammatory or early stage invasive breast cancer;
• HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion criteria

• metastatic disease (Stage IV) or bilateral breast cancer;
• previous anticancer therapy or radiotherapy for any malignancy;
• other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
• insulin-dependent diabetes;
• clinically relevant cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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417 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: Docetaxel

Drug: Herceptin

2

Experimental group

Treatment:

Drug: Docetaxel

Drug: Herceptin

Drug: Pertuzumab

3

Experimental group

Treatment:

Drug: Herceptin

Drug: Pertuzumab

4

Experimental group

Treatment:

Drug: Docetaxel

Drug: Pertuzumab