Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Inclusion Criteria:
- female patients, >/=18 years of age
- early stage HER2-positive breast cancer
- scheduled to receive neoadjuvant therapy with the objective of conservative surgery
- ECOG performance status 0, 1 or 2
Exclusion Criteria:
- partially or totally lobular carcinoma
- inflammatory breast cancer
- bifocal and/or bilateral tumour
- metastases
- previous treatment with chemotherapy, radiation therapy or hormone therapy for breast
cancer
- previous history of cancer (other than curatively treated basal and squamous cell
carcinoma of the skin and/or in situ carcinoma of the cervix) relapsing within the 5
years before study entry or in situ contralateral breast carcinoma
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological complete response (according to Chevalier criteria, reviewed by independent committee)
Outcome Time Frame:
after 6 cycles (18 weeks) of neoadjuvant therapy
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ML22229
NCT ID:
NCT01142778
Start Date:
May 2010
Completion Date:
November 2017
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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