None listed
Conditions
Brief summary
This study will examine the impact of prognostic gene profile testing using EndoPredict on adjuvant treatment recommendations in early breast cancer patients who are ER positive. Who is it for? You may be eligible for this study if you are a female aged between 18-80 years and have early stage invasive breast cancer which is estrogen receptor positive and HER2 negative. Potential participants will also need to be patients at the Westmead Breast Cancer Institute, Victorian Comprehensive Cancer Centre and St Vincent’s Hospital Sydney. Study details This study will involve participants going through their usual cancer treatment. Participants will be followed up for 10 years on an annual basis to assess treatment recommendations and decisions in that time. This study will enable the researchers to accurately identify those women who can safely avoid chemotherapy
Interventions
All consenting and eligible patients will be enrolled into the Study. For the enrolled patients, the allocated pathologist will select the appropriate tumour material for testing with the EndoPredict® . All enrolled patients will be discussed at a multidisciplinary team (MDT) meeting, no later than 14 days from their surgical date. Adjuvant treatment decisions regarding chemotherapy and hormonal therapy will be documented, based firstly on the standard histopathology results only (including Ki-
All consenting and eligible patients will be enrolled into the Study. For the enrolled patients, the allocated pathologist will select the appropriate tumour material for testing with the EndoPredict® . All enrolled patients will be discussed at a multidisciplinary team (MDT) meeting, no later than 14 days from their surgical date. Adjuvant treatment decisions regarding chemotherapy and hormonal therapy will be documented, based firstly on the standard histopathology results only (including Ki-67) (the Initial MDT Recommendation) and secondly, on the basis of additional information from the EndoPredict® test result (the Final MDT Recommendation). Information regarding the specific chemotherapy and endocrine regimen, including name of drug, and intended treatment duration, will be recorded if the information is routinely avaialable. If not, site needs to document if chemotherapy, chemotherapy plus endocrine therapy or radiotherapy is recommended . Patients will be seen by the treating clinician (medical oncologist/breast surgeon) who will deliver and discuss the final MDT recommendation. Should the treating clinician medical oncologist not accept the final MDT recommendation, and another treatment (Clinical Treatment Decision) was recommended upon meeting the patient, the treatment change and the reason for this change will be documented. Should the patient not accept the recommendation of the medical oncologist, then the reason for the refusal should be documented (Final Treatment Plan). This Study will record the treatment that was actually received by the patient (Actual Treatment – type and duration). Patients enrolled in this study will be followed up annually in clinic for a total 10 years. Long-term follow-up (greater than 10 years) will record dates of breast cancer recurrence and death only, if feasible.
Sponsors
Westmead Breast cancer Institute, Westmead Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Females (18 – 80 years) ECOG Performance Status 0-1 Resected estrogen-receptor-positive, HER2-negative, early stage invasive breast cancer (T1-T2N0-1M0) Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells of any intensity will be considered positive. HER2 status will be evaluated by in situ hybridisation using current ASCOCAP guidelines for scoring (HER2:CEP17 ratio >2 will be considered positive
Exclusion criteria
Tumor size T3-T4 Non-invasive breast cancer (e.g., Paget's disease, DCIS) Greater than 3 involved axillary nodes Tumors that are estrogen-receptor negative or HER2 positive Distant metastatic disease Unable to give informed consent Significant co-morbidities or contraindications for adjuvant chemotherapy ECOG Performance Status 2-4
Outcome results
None listed