Overview

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

Status:
Completed
Trial end date:
2017-01-24
Target enrollment:
0
Participant gender:
Female
Summary
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Cyclophosphamide
Docetaxel
Epirubicin
Fluorouracil
Trastuzumab
Criteria
Inclusion Criteria:

- Adult women greater than or equal to (≥) 18 years of age

- Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I to IIIC,
including inflammatory and multicentric/multifocal breast cancer, with tumor size ≥1
centimeter (cm) by ultrasound or ≥2 cm by palpation, centrally confirmed HER2-positive
(immunohistochemical score [IHC] 3+ or in situ hybridization [ISH]-positive)

- At least 1 measurable lesion in breast or lymph nodes (≥1 cm by ultrasound or ≥2 cm by
palpation), except for inflammatory carcinoma (T4d)

- Baseline left ventricular ejection fraction (LVEF) ≥55%

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Adequate organ function at Baseline

Exclusion Criteria:

- History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma

- Past or current history of malignant neoplasms, except for curatively treated basal
and squamous cell carcinoma of the skin and in situ carcinoma of the cervix

- Metastatic disease

- Any prior therapy with anthracyclines

- Prior anti-HER2 therapy or biologic or immunotherapy

- Serious cardiac illness

- Pregnant or lactating women