Conditions: Breast Cancer
Keywords: Neoadjuvant nab-paclitaxel luminal breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief 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)

Arms:
arm 1: The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.

Interventions: intervention 1: Nab-paclitaxel
Intervention descriptions: intervention 1: None

Protocol document: