Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer
Study GEICAM 2011-02 is a multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive HER2 negative patients amenable to receive neoadjuvant chemotherapy.
The primary objetive 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  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)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II, Open-label, Non-randomized Study of Nab-paclitaxel for the Neoadjuvant Treatment of Patients With Stage II and III Luminal Breast Cancer|
- The residual cancer burden grade III (RCB-III). [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]
The RCB-III will be reported, including a 95% confidence interval. The estimate of the RCB-III will be calculated as follows:
Overall Response Rate = Number of patients with RCB-III / ITT population
- Analyses for pathological Response Rate [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]The pCR (RCB-0) rate will be reported including a 95% confidence interval. The estimate of the pCR rate will be calculated as follows: pCR Rate = Number of patients with pCR / ITT population. Additional exploratory analysis will be performed calculating the rate of RCB-0 + RCB-I.
- Analyses for objective response [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]
The ORR will be reported, including a 95% confidence interval. The estimate of the ORR will be calculated as follows:
Overall Response Rate = Number of CRs, PRs / ITT population
- Analyses for rate of conversion to BCS [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]
The conversion from the initially planned mastectomy to BCS will be reported including a 95% confidence interval. The estimate of the rate of conversion to BCS will be calculated as follows:
BCS rate = Number of patients with BCS / Number of patients with initially planned mastectomy.
- Time-to-event Analyses [ Time Frame: Death or up to 5 years whatever occurs first for each patient ] [ Designated as safety issue: No ]Invasive Disease Free Survival will be evaluated. It is defined as the time (days)from the date of randomization until the date of objective recurrent disease (local, regional or distant), second primary invasive malignancy (breast or non-breast) or death from any cause. For patients not known to have died as of the data cut-off date and who do not have recurrent disease or second primary tumor, invasive disease-free survival will be censored at the last contact date. DCIS will not be considered an event for the purpose of this analysis, but will be collected in the e-CRF.
- Toxicity and tolerability of nab-paclitaxel analysis. [ Time Frame: During treatment and until 30 days after the last dose of each patient study treatment ] [ Designated as safety issue: Yes ]
Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010) that occur during the study treatment period or within 30 days of the last dose of study treatment, regardless of causality and according to the relationship to study drug as assessed by the investigator, will be collected and evaluated. Additionally, the following safety-related outcomes will be summarized:
- study treatment discontinuations due to adverse events.
- hospitalizations and transfusions
- use of key concomitant medications or growth factors
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565499
|Corporación Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital Universitario de Canarias|
|La Laguna, Santa Cruz de Tenerife, Spain, 38320|
|Complejo Hospitalario Universitario A Coruña|
|A Coruña, Spain, 15006|
|Hospital Clinic i Provincial|
|Barcelona, Spain, 08036|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|
|Complejo Hospitalario de Jaén|
|Jaén, Spain, 23007|
|Hospital Insular Materno Infantil de Las Palmas|
|Las Palmas de Gran Canaria, Spain, 35016|
|Hospital Universitario Puerta de Hierro|
|Madrid, Spain, 28035|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital La Paz|
|Madrid, Spain, 28046|
|Hospital Universitario Morales Meseguer|
|Murcia, Spain, 30008|
|Instituto Oncológico de Guipúzcoa|
|San Sebastián, Spain, 20012|
|Hospital Virgen de la Salud|
|Toledo, Spain, 45004|
|Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Study Director:||Miguel Martín, PhD., MD.||Hospital General Universitario Gregorio Marañón|