Real-world Evidence Prospective Study on the Effect of Nab-paclitaxel Treatment on the Clinical Outcomes and HRQoL in Patients With MBC in Greece

NCT02626013 | Completed

• 1 other identifier: NIPMS-GENESIS-ONCO-GRC-001
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population. Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of the best objective response to nab-paclitaxel treatment in eligible MBC patients as measured from the start of therapy until disease progression, unacceptable toxicity, or termination of study participation

  The proportion of objective responders \[patients with either a complete response (CR) or a partial response (PR) as the best objective response\] as measured by routine assessments from the start of nab-paclitaxel therapy until disease progression, occurrence of unacceptable toxicity, or study participation termination whichever occurs sooner

  as measured by routine assessments from the start of nab-paclitaxel therapy (at least 6 months post-treatment onset and up to 12 months) until disease progression, occurrence of unacceptable toxicity, or study participation termination

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated

You may qualify if:

• Adult patients (18 years and older);
• Patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated;
• Patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study;
• Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
• Patients must have signed an informed consent document;
• Patients must be able to read, understand and complete the study specific questionnaire

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from participation in this study:
• Patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study;
• Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
• Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.

Sponsors & Collaborators

• Genesis Pharma S.A.: lead

Study Sites (1)

Athens

Athens, GR11528, Greece

Location

Related Publications (1)

• Koumarianou A, Makrantonakis P, Zagouri F, Papadimitriou C, Christopoulou A, Samantas E, Christodoulou C, Psyrri A, Bafaloukos D, Aravantinos G, Papakotoulas P, Baka S, Andreadis C, Alexopoulos A, Bompolaki I, Kampoli Kappa, Liori S, Karvounis K, Ardavanis A. ABREAST: a prospective, real-world study on the effect of nab-paclitaxel treatment on clinical outcomes and quality of life of patients with metastatic breast cancer. Breast Cancer Res Treat. 2020 Jul;182(1):85-96. doi: 10.1007/s10549-020-05677-4. Epub 2020 May 16.

  PMID: 32418045 RESULT

Related Links

• Abstract published at Breast Cancer Research \& Treatment. Epub 2020 May 16.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kiki Karvounis

  GenesisPharma Medical Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 10, 2015
• Study Start: April 12, 2016
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

GR (1)