Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer

Roche

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: trastuzumab [Herceptin]

Drug: pertuzumab [Perjeta]

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02402712

BO29159

2014-001458-40 (EudraCT Number)

Details and patient eligibility

About

This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400.

Enrollment

418 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection. Patients with measurable and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 are eligible.
HER2-positive disease (defined as either immunohistochemistry [IHC] 3 + or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor or metastatic site if primary tumor not available
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Left ventricular ejection fraction (LVEF) of at least 50%
Negative serum pregnancy test result at baseline and use of effective contraception as defined by the protocol

Exclusion criteria

Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease. Note: Prior to study entry, up to two lines of hormonal therapy for metastatic or locally recurrent disease are permitted, one of which may be in combination with everolimus.
Disease-free interval of less than 6 months from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of breast cancer
Previous approved or investigative anti-HER2 agents as neoadjuvant or adjuvant therapy for any breast cancer treatment, except Herceptin
History of persistent Grade 2 or higher hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
Current peripheral neuropathy of Grade 3 or greater
History of other malignancy within the last 5 years prior to first dose of study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
Inadequate organ function
Uncontrolled hypertension with or without medication
Clinically significant cardiovascular disease
History of LVEF decline to below 50% during or after prior Herceptin neo-adjuvant or adjuvant therapy
Current known infection with HIV, hepatitis B virus, or hepatitis C virus
Severe uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or that would put the patient at high risk for treatment-related complications, including severe pulmonary conditions/illness
Pregnant or lactating women
Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy
History of receiving any investigational treatment within 28 days prior to first dose of study drug administration (dosing) or concurrent participation in any interventional clinical trial