Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Terminated

CT.gov ID

NCT01476111

Collaborator

(none)

117

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms, Breast

Study Design

Study Type:

Observational

Actual Enrollment :

117 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Patients with primary invasive breast cancer

Outcome Measures

Primary Outcome Measures

The presence of a specific predictive gene expression signature in tumor tissues [At randomization and at definitive surgery which may be up to 30 weeks post randomization.]
The presence of immune infiltration in tumor tissues [At randomization and at definitive surgery which may be up to 30 weeks post randomization.]
The presence of other candidate biomarkers in tumor tissues [At randomization and at definitive surgery which may be up to 30 weeks post randomization.]
The pathological response (complete response or partial response) in the breast. [At definitive surgery which may be up to 30 weeks post randomization.]
Disease free interval [Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.]
Disease free survival [Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.]
Overall survival [Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient has 18 years of age or older at the time of consent.
The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study.
The patient has a histologically or cytologically confirmed primary invasive breast cancer.
The patient has provided written informed consent before any new information or new material is provided to the Sponsor.
The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.

Exclusion Criteria:

Not applicable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Newark	Delaware	United States	19713
2	GSK Investigational Site	Plantation	Florida	United States	33324
3	GSK Investigational Site	Charleston	South Carolina	United States	29414
4	GSK Investigational Site	Amarillo	Texas	United States	79106
5	GSK Investigational Site	Bruxelles		Belgium	1200
6	GSK Investigational Site	Namur		Belgium	5000
7	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg	Germany	72076
8	GSK Investigational Site	Erlangen	Bayern	Germany	91054
9	GSK Investigational Site	Frankfurt	Hessen	Germany	60590
10	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern	Germany	18059
11	GSK Investigational Site	Dortmund	Nordrhein-Westfalen	Germany	44137
12	GSK Investigational Site	Essen	Nordrhein-Westfalen	Germany	45136
13	GSK Investigational Site	Homburg	Saarland	Germany	66421
14	GSK Investigational Site	Chemnitz	Sachsen	Germany	09116
15	GSK Investigational Site	Kiel	Schleswig-Holstein	Germany	24105
16	GSK Investigational Site	Napoli	Campania	Italy	80131
17	GSK Investigational Site	Aviano (PN)	Friuli-Venezia-Giulia	Italy	33081
18	GSK Investigational Site	Roma	Lazio	Italy	00189
19	GSK Investigational Site	Milano	Lombardia	Italy	20141
20	GSK Investigational Site	Pavia	Lombardia	Italy	27100
21	GSK Investigational Site	Torino	Piemonte	Italy	10126
22	GSK Investigational Site	Ryazan		Russian Federation	390011
23	GSK Investigational Site	St. Petersburg		Russian Federation	197022
24	GSK Investigational Site	St. Petersburg		Russian Federation	197758
25	GSK Investigational Site	Bournemouth		United Kingdom	BH7 7DW
26	GSK Investigational Site	Derby		United Kingdom	DE22 3DT
27	GSK Investigational Site	Edinburgh		United Kingdom	EH4 2XU
28	GSK Investigational Site	Nottingham		United Kingdom	NG5 1PB
29	GSK Investigational Site	Poole		United Kingdom	BH15 2JB