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Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: 5-Fluorouracil, Cyclophosphamide, Docetaxel, Epirubicin, Herceptin IV [trastuzumab]
Countries: Argentina, Brazil, Canada, Colombia, Czechia, Estonia, France, Germany
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- San Miguel de Tucumán, Argentina
- San Miguel de Tucumán, Argentina
- Salvador, Estado de Bahia, Brazil
- Curitiba, Paraná, Brazil
- Natal, Rio Grande do Norte, Brazil
- Itajaí, Santa Catarina, Brazil
- Jaú, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Sorocaba, São Paulo, Brazil
- Montreal, Quebec, Canada
- Québec, Canada
- Bogotá, Colombia
- Bogotá, Colombia
- Pereira, Colombia
- Olomouc, Czechia
- Pardubice, Czechia
- Prague, Czechia
- Prague, Czechia
- Tallinn, Estonia
- Tartu, Estonia
- Besançon, France
- Grenoble, France
- La Tronche, France
- Le Mans, France
- Paris, France
- Reims, France
- Saint-Cloud, France
- Berlin, Germany
- Berlin, Germany
- + 76 more on CT.gov