Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

Breast Neoplasms Clinical Trial

— AMBER  

Official title:

Retrospective Observational Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02655159
• Other study ID #: CEL-CMM-2015-01
• Status: Terminated
• Phase: N/A
• First received: January 12, 2016
• Last updated: October 28, 2016
• Start date: January 2016
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Celgene Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.

To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.

Description:

This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.

The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.

This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women =18 years of age.

• Confirmed diagnosis of MBC (stage IV).

• Breast adenocarcinoma confirmed histologically.

• HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.

• Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.

• Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).

Exclusion Criteria:

• Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.

• Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.

• Patients who have taken part in any clinical trial (interventional) during the study period.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Spain	Capio Clideba	Badajoz	Extremadura
Spain	Hospital Infanta Cristina	Badajoz	Extremadura
Spain	Hospital Vall d´Hebron	Barcelona	Cataluña
Spain	Hospital Universitario Burgos	Burgos	Castilla y León
Spain	Hospital Santa Lucía	Cartagena	Murcia
Spain	Complejo Hospitalario Jaén	Jaén	Andalucía
Spain	Hospital 12 octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Quirón	Madrid
Spain	MD Anderson	Madrid
Spain	Hospital Morales Meseguer	Murcia
Spain	Complejo Hospitalario Orense	Orense	Galicia
Spain	Hospital Navarra	Pamplona	Navarra
Spain	Hospital Universitario San Joan Reus	Reus	Cataluña
Spain	Hospital Clínico Salamanca	Salamanca	Castilla y León
Spain	Hospital Virgen Salud	Toledo	Castilla La Mancha
Spain	Hospital Clínico Valladolid	Valladolid	Castilla y León
Spain	Hospital Clínico Lozano Blesa	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.	Up to approximately 8 months	No
Secondary	Overall Response Rate (ORR)	The number of patients who achieve a complete response (CR) or partial response (PR) during the first 3 treatment cycles with nab-paclitaxel and the corresponding 95% CI will be calculated.	Up to approximately 8 months	No
Secondary	Disease control rate (DCR)	The percentage of patients with complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks, and the corresponding 95% confidence intervals (CI) will be calculated.	Up to approximately 8 months	No
Secondary	Time to disease progression (TTP)	Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death due to progression. TTP will be estimated by using the Kaplan-Meier method. The median and confidence interval for the median at 95% reliability (95% CI) will be calculated. In patients who show no disease progression or who have not died, the date of censoring may be the day on which the patient's death is documented, the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months	No
Secondary	Progression-free survival (PFS)	Is defined as the time from the start of treatment with nab-paclitaxel to disease progression or death from any cause. PFS will be estimated by using the Kaplan-Meier method. Patients who have shown no disease progression or who have not died at the time of data collection will be censored on the date on which it was last known that no disease progression occurred. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months	No
Secondary	Overall survival (OS)	Is defined as the time from the start of treatment with nab-paclitaxel to death from any cause. OS will be estimated by using the Kaplan-Meier method. Patients who have not died at the time of data collection will be censored on the date on which they are last known to be alive. The date of censoring may be the day of the last follow-up assessment or the day of the last tumor assessment in case the foregoing is not available.	Up to approximately 8 months	No
Secondary	Adverse Events (AEs)	Number of participants with adverse events	Up to approximately 8 months	Yes