Clinical trial NCT01840306: Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Official title: Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
HER2 Positive Breast Cancer
HER2 Negative Breast Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2013-04-25
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * HER2 positive breast cancer:Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer.
* HER2 negative breast cancer:Female patients with newly diagnosed HER2 negative breast cancer.

Brief summary: Primary Objective:

(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).

Secondary Objective:

To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

Detailed description: This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.

Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.

Blood specimens will be taken:

* before starting treatment (cohort 1 and 2)
* after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
* within one month following 1st treatment of HER2 targeted treatment (cohort 1)
* approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)

Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.

Eligibility criteria: Inclusion Criteria:

1. Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.

   OR

   - Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
2. Patient must be female and aged 18 years or over.
3. Patient must provide written informed consent.

Exclusion Criteria:

1. Patients who do not fulfil the inclusion criteria mentioned above

Primary outcomes:
measure: Identification of Extra Cellular RNAs/proteins in sera from cancer patients
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Donegal
country: Ireland
facility: Letterkenny General Hospital
city: Drogheda
country: Ireland
facility: Our Lady of Lourdes Hospital
city: Dublin
country: Ireland
facility: Beacon Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital
city: Sligo
country: Ireland
facility: Sligo General Hospital
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
References: