Trials / Completed
CompletedNCT02411344
Preoperative Study With Trastuzumab, Pertuzumab and Letrozole in Breast Cancer Patients Sensitive to Hormonal Therapy
PERtuzumab-trastuzumab Plus lEetrozoLe In Endocrine Sensitive Breast Cancer: a Phase II neoAdjuvant Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Istituto Oncologico Veneto IRCCS · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this study is: * to evaluate the rate of pathologic complete response (pCR), as defined as complete disappearance of invasive tumor in breast and axillary nodes. * to estimate the percentage of clinical objective responses (cOR) (complete plus partial) in the breast, as assessed by ultrasonography (US) * to estimate the percentage of breast conservative surgery * to evaluate the safety profile * To perform correlative biomarker analyses
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pertuzumab | * 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). |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2018-01-12
- Completion
- 2018-01-12
- First posted
- 2015-04-08
- Last updated
- 2018-09-18
Locations
8 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT02411344. Inclusion in this directory is not an endorsement.