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出境医 / 临床实验 / Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
Study Description
Brief Summary:
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients.
| Condition or disease |
|---|
| Breast Cancer Female |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | October 31, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation [ Time Frame: 1 year ]
The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). Oncotype DX test results assign a Recurrence Score - a number between 0 and 100 - to the early-stage breast cancer or DCIS.
Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects.
Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It's unclear whether the benefits of chemotherapy outweigh the risks of side effects.
Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.
Secondary Outcome Measures :
- Evaluation of the association of the RS with tumor cell dissemination into bone marrow [ Time Frame: 1 year ]Bone marrow sampling is performed during primary surgery as part of the clinical routine. The presence of disseminated tumor cells (DTC status) is evaluated by immunostaining.
- Correlation of the RS with age [ Time Frame: 1 year ]age in years
- Correlation of the RS with tumor nodal status [ Time Frame: 1 year ]
- Correlation of the RS with tumor grading [ Time Frame: 1 year ]
- Correlation of the RS with proliferation marker Ki-67 [ Time Frame: 1 year ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Women with breast cancer
Criteria
Inclusion Criteria:
- women ≥ 18 years of age
- histologically proven unilateral primary non-metastatic invasive breast cancer
- ER-/ or PR- positive and HER2-negative
- N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically.
- surgery or planed surgery at the Department of women's health, Tuebingen
- written informed consent into IRMA
Exclusion Criteria:
- ER-negative
- HER2-positive
- > 3 involved lymph-nodes
- bilateral breast cancer
- preexisting cancer disease within the last 10 years
- preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)
- primary systemic therapy
- locally advanced, inoperable or metastatic breast cancer
- pregnant or lactating patients
- inadequate general condition (not fit for chemotherapy)
Contacts and Locations
Contacts
| Contact: Andreas Hartkopf, MD | 4970712982211 | andreas.hartkopf@med.uni-tuebingen.de |
Locations
| Germany | |
| Department for Women's Health | Recruiting |
| Tübingen, BW, Germany, 72086 | |
| Contact: Brucker Sara, MD | |
Sponsors and Collaborators
University Hospital Tuebingen
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||
| First Posted Date | May 23, 2019 | ||||
| Last Update Posted Date | February 11, 2020 | ||||
| Actual Study Start Date | March 1, 2019 | ||||
| Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation [ Time Frame: 1 year ] The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). Oncotype DX test results assign a Recurrence Score - a number between 0 and 100 - to the early-stage breast cancer or DCIS.
Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects.
Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It's unclear whether the benefits of chemotherapy outweigh the risks of side effects.
Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients | ||||
| Official Title | Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer | ||||
| Brief Summary | IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Women with breast cancer | ||||
| Condition | Breast Cancer Female | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
250 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | October 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03961880 | ||||
| Other Study ID Numbers | IRMA | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital Tuebingen | ||||
| Study Sponsor | University Hospital Tuebingen | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital Tuebingen | ||||
| Verification Date | February 2020 | ||||
