Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
NCT02411344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2018-09-18
Summary
The purpose of this study is to evaluate the activity of molecular response in endocrine sensitive breast cancer HER2+/HR+ patients treated with Pertuzumab-trastuzumab plus Ietrozole.
Conditions
- Endocrine Sensitive HER2+/HR+ Breast Cancer
Interventions
- DRUG
-
* Pertuzumab 840 mg loading dose iv on day one, followed by 420 mg iv every 3 weeks for 5 cycles * Trastuzumab 8 mg/kg loading dose iv on day 2, followed by 6 mg/kg iv on day 2 of each subsequent 3 weekly cycle * Letrozole 2.5 mg daily p.o. for five 21-day cycles (to be continued until surgery).
Sponsors & Collaborators
-
Association for Translational Research in Oncology (AS.T.R.O.)
collaborator UNKNOWN -
Istituto Oncologico Veneto IRCCS
lead OTHER
Principal Investigators
-
Valentina Guarneri, MD; PhD · Medical Oncology 2, Istituto Oncologico Veneto
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2018-01-12
- Completion
- 2018-01-12
Countries
- Italy
Study Locations
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