NCT01565499

Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer

Phase II, Open-label, Non-randomized Study of Nab-paclitaxel for the Neoadjuvant Treatment of Patients With Stage II and III Luminal Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.

Detailed description

The primary objective of the trial is to determine the percentage of patients with poor response \[residual cancer burden III (RCB-III) rate\] in contrast to good response \[residual cancer burden 0/I RCB-0/1\] measured by the Symmans criteria \[20\] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel. The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery. The total number of patients to be included in this study is 78 patients. The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel

Timeline

• Start date: 2012-04-17
• Primary completion: 2014-06-01
• Completion: 2018-05-27
• First posted: 2012-03-28
• Last updated: 2023-03-30
• Results posted: 2020-11-18

Locations

13 sites across 1 country: Spain