Breast CancerBreast NeoplasmsHormone Receptor Positive Tumor
Investigational drug(s) / intervention(s)
Multi-parameter tests
Multi-parameter tests: Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) risk of recurrence (ROR) analysis CE marked assay termed Prosigna™ using digital bar code technology (NanoString Technologies Inc.).
Study summary
The present project focuses on how to reduce both over- and under-treatment with adjuvant chemotherapy to a large number of breast cancer patients in Norway. A set of primary tumor prognostic factors can be analysed for potential achievement of this. Furthermore, multi-parameter tests, including detailed molecular analysis of the primary tumors might further improve the selection of patients among the lymph node negative. The study seeks to advance the development of personalised treatment of patients with early breast cancer without lymph node metastasis, by the evaluation of multi-parameter analysis as a means of identifying those patients who are likely to benefit from chemotherapy whilst sparing those who are unlikely to do so from an unnecessary and unpleasant treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Written informed consent (informed consent document approved by the Independent Ethics Committee \[IEC\]) obtained prior to any study-specific procedure
2. Female or male age ≥ 18 years
3. Able to comply with the protocol
4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected
5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi)
6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative.
Exclusion Criteria:
1. Metastasis to regional lymph nodes or distant sites/organs.
2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed.
3. HER2 positive
4. ER and PgR negative tumor (\< 1% expression)
5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer
6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered).
7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.
Primary outcome measure(s)
Treatment decision differences with or without Prosigna test — 3 years Differences in the number of patients receiving the various adjuvant treatments using Prosigna-test (in addition to the routine clinicopathological variables) as basis for treatment decisions compared to standard adjuvant treatment recommendations (based on clinicopathological variables only).
Distant recurrence-free interval — 8 years from study start Patients receiving no adjuvant chemotherapy based on Prosigna test results in combination with routine clinicopathological variables, will be recorded for metastatic events during the follow up period. To identify factors associated with survival, methods to be applied include Kaplan-Meier plots and Cox regression analyses. To statistically assess the association between breast cancer subgroups found in the analysis described above and clinical endpoints, statistical tests for comparison of survival in two or more groups (log rank test) will be used. Multivariate regression analysis will be used to adjust for other factors (such as age). Possible violations of the proportional hazards assumption inherent in both types of tests above will be detected using graphical methods as well as formal tests based on the Schoenfeld residuals.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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