A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE III STUDY OF THE SAFETY AND EFFICACY OF HERCULES PLUS TAXANE VERSUS HERCEPTIN® PLUS TAXANE AS FIRST LINE THERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-062-14
• Lead Sponsor: Mylan GmbH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. ≥18 years of age.
2. Histologically confirmed diagnosis of breast cancer.
3. Locally recurrent or MBC that is not amenable to curative surgery and/or radiation.
4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH) (as defined by a ratio >2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) based on the sponsor-identified central laboratory prior to randomization. Archival tumor tissue samples can be used.
5. Documentation of estrogen receptor/progesterone receptor (ER/PgR) status (positive or negative) based on either a local or central laboratory report must be available before randomization.

Exclusion Criteria

1. Prior systemic therapy in the metastatic disease setting. This includes: chemotherapy, signal transduction inhibitors (e.g., lapatinib), HER2 targeted therapy (e.g., trastuzumab), or other investigational anticancer therapy.
2. Prior treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2.
3. Participation in the active treatment phase of an investigational drug study ≤28 days prior to randomization.
4. Patients with bone or skin as the only site of disease. Patients with skin lesions measurable by CT scans or MRI as only site of measurable disease are allowed.
5. Surgery or radiotherapy ≤2 weeks preceding Day 1. Target lesions have to be outside the irradiated fields and the patient has fully recovered from surgery or radiotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified