CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 30 target
Drug / intervention
nab-paclitaxeldrug
Likely dose
nab-paclitaxel 125mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01625429
NCT01625429Phase 2Unknown
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A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer

Shanghai Cancer Hospital, China·interventional·Posted Jun 21, 2012·Updated Nov 9, 2012

In Brief

A Phase 2 clinical trial evaluating nab-paclitaxel for Breast Cancer. Targeting 30 participants across 1 site.

Detailed Summary

This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
20132014201520162017201820192020202120222023202420252026
First PostedJun 21, 2012
Enrollment StartJun 1, 2012
Primary CompletionSep 1, 2013
Study CompletionJun 1, 2017
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 14.0 years ago

Interventions

nab-paclitaxeldrug

nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity