A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETYOF ABP 980 COMPARED WITH TRASTUZUMAB IN SUBJECTS WITH HER2 POSITIVE EARLY BREAST CANCER

Not Applicable

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

• Registration Number: PER-030-13
• Lead Sponsor: AMGEN INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

8.3.1 Inclusion Criteria
Subjects MUST satisfy all of the following entry criteria before they will be allowed to participate in the study:
1. Females ≥ 18 years old
2. Histologically confirmed invasive breast cancer
3. Planning for surgical resection of breast tumor and SN or axillary lymph node resection
4. Planning neoadjuvant chemotherapy
5. HER2 positive disease defined as:
o +3 overexpression by immunohistochemistry (IHC) or
o HER2 amplification by fluorescence in situ hybridization (FISH)
6. Measurable disease ( assessment method used in order of priority: ultrasound, mammography, MRI, or physical examination) in the breast after diagnostic biopsy, defined as longest diameter ≥ 2.0 cm
7. Known ER and PR hormone receptor status at study entry
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. Left ventricular ejection fraction (LVEF) of ≥ 55 % by 2D echocardiogram
(Others, please see Study Protocol)

Exclusion Criteria

8.3.2 Exclusion Criteria
If any of the following apply, the subject MUST NOT enter the study:
1. Bilateral breast cancer
2. Presence of know metastases
3. Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer
4. Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
5. Pre-existing clinically significant (≥ grado 2) peripheral neuropathy
6. Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG) or current poorly controlled hypertension
7. Severe dyspnea at rest requiring supplementary oxygen therapy
(Others, please see Study Protocol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified