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Reaching for Evidence-baSed Chemotherapy Use in Endocrine Sensitive Breast Cancer (RESCUE)

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ClinicalTrials.gov Identifier: NCT03503799
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Center for Clinical Trials Philipps University Marburg
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology

Brief Summary:
Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.

Condition or disease Intervention/treatment
Primary Invasive Breast Cancer Estrogen Receptor Positive Tumor Human Epidermal Growth Factor Receptor 2 Negative Tumor Other: Observation

Detailed Description:

The goal of the study is to receive current and comprehensive information about the diseasefree (remote metastasis free and recurrence free) interval of EndoPredict® low risk patients.

The study is organized and managed by the NOGGO e.V. (North Eastern German Society of Gynaecological Oncology e.V.) study coordination office under the existing and efficient infrastructure. All patients who receive gene expression analysis with EndoPredict® and satisfy the remaining inclusion / exclusion criteria may participate in the study. Data collection is prospective and non-interventional. The recruitment of the required patients is expected to take a maximum of 36 months .

It must be emphasized that the study is data collection only and not an interventional study. This means that the choice and implementation of the therapy as well as the treatment assessments and frequency during and after the treatment can only be determined by the Investigator.

The decision to participate in the study is independent of the patient´s therapy within the framework of a study. Patient data will be recorded at the time of inclusion and once a year thereafter. Patient follow-up will be by phone from the second year onward.

Primary objective is to show that female patients who have been tested as "low risk" by EPclin and have been treated with endocrine therapy only for at least 5 years have a 10-year DMFS rate > 90% (lower boundary of the one-sided 95% confidence interval).

Secondary objectives comprise the evaluation of DMFS (distant metastasis free survival) , DFS (disease free survival) and OS (overall survival) rates at different time points and for different groups. Assessment of the given chemotherapy regimens and the given endocrine therapy will be performed and the proportions of patients will be determined with respect to the received treatment and its duration in different groups. Furthermore, the proportion of patients in whom the tumor board recommendation follows the EndoPredict® result and the proportion of patients actually treated according to EndoPredict® result will be determined.

The association between outcome and treatment, EPclin, EP, and classical prognostic factors will be investigated in different groups of patients. The correlation and concordance between EPclin calculations derived from biopsies and surgical specimens will be assessed.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : May 1, 2031
Estimated Study Completion Date : May 1, 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Observational Group
Patients with primary invasive breast cancer, Stage I/II; ER positive, HER2 (human epidermal growth factor receptor 2) negative, N0-N1, T1-T3, tested with EndoPredict®, age over 18 years, informed consent
Other: Observation

Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy

Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival

Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone.

Status of Menopause Disease status Anti-tumor therapy Survival

Treatment after end of the study The patient will be treated during and after end of study by physician's choice.





Primary Outcome Measures :
  1. Distant metastasis free survival [ Time Frame: 10 years ]
    To show that female patients who have been tested as "low risk" by EndoPredict® (EPclin) and have been treated with endocrine therapy only for at least 5 years have a 10-year distant metastasis-free survival (DMFS) > 90 % (lower boundary of the one-sided 95 % confidence interval)


Secondary Outcome Measures :
  1. DMFS "low risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DMFS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

  2. DFS "low risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DFS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

  3. OS "low risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of OS of patients with EPclin "low risk" (or EP "low risk" [EP score <5] if EPclin cannot be calculated after surgery in the neoadjuvant setting) (in all patients, in the relevant target group and separately in men and women and in pre- and postmenopausal women with regard to treatment).

  4. DMFS "high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DMFS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

  5. DFS "high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DFS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

  6. OS "high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of OS of patients with EPclin "high risk" in all patients and separated in men and women as well as pre- and postmenopausal women with regard to treatment).

  7. DMFS "high risk + low risk" [ Time Frame: 3, 5 and 10 years ]
    DMFS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

  8. DFS "high risk + low risk" [ Time Frame: 3, 5 and 10 years ]
    DFS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

  9. OS "high risk + low risk" [ Time Frame: 3, 5 and 10 years ]
    OS for patients who have / have not been treated according to EPclin/ EP result (all patients and subgroup analyses as specified in secondary objectives 1 and 2).

  10. Portion of patients tumor board follows the EndoPredict® result [ Time Frame: 1 year ]
    Assessment of the proportion of patients in whom the tumor board follows the EndoPredict® result in regard to treatment recommendation (in all patients and separately for men and women).

  11. Portion of patient treated according EndoPredict® result [ Time Frame: 1 year ]
    Assessment of the proportion of patients who were actually treated according to the EndoPredict® result (in all patients and separately for men and women).

  12. Prognostic Performance of classical prognostic factors compared to EndoPredict® [ Time Frame: 3, 5 and 10 years ]
    Assessment of the classical prognostic factors tumor size, nodal status, grading, quantitative estrogen receptor, quantitative progesterone receptor and quantitative Ki67 and evaluation of their prognostic performance compared to EPclin and EP in univariate and multivariate analyses of DMFS, DFS, OS (in all patients, separately for men and women, only in patients who have been treated according to the EndoPredict® result).

  13. DMFS "low risk vs. high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DMFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC (immunohistochemistry)-classification.

  14. DFS "low risk vs. high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of DFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

  15. OS "low risk vs. high risk" [ Time Frame: 3, 5 and 10 years ]
    Assessment of OS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

  16. DMFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors [ Time Frame: 3, 5 and 10 years ]
    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of DMFS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

  17. DFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors [ Time Frame: 3, 5 and 10 years ]
    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of DFS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

  18. OS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors [ Time Frame: 3, 5 and 10 years ]
    Assessment of proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors, respectively, and stratified analysis of OS of patients with ki67-values low (≤ 10%)/ intermediate (11-24%)/ high (≥ 25%) and EPclin low risk vs high risk.

  19. DMFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines [ Time Frame: 3, 5 and 10 years ]
    Assessment of DMFS after 3, 5 and 10 years of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

  20. DFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines [ Time Frame: 3, 5 and 10 years ]
    Assessment of DFS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

  21. OS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines [ Time Frame: 3, 5 and 10 years ]
    Assessment of OS of patients with low risk vs. high risk as defined by national (German S3) and international (St. Gallen Consensus) guidelines based on IHC-classification.

  22. Chemotherapy regimens [ Time Frame: 1 year ]
    Description of the given chemotherapy regimens (in all patients and separately for men and women).

  23. Given endocrine therapy [ Time Frame: 10 years ]
    Description of the given endocrine therapy (in all patients and separately for men and women).

  24. Duration of endocrine therapy [ Time Frame: 10 years ]
    Duration of the endocrine therapy (in all patients and separately for men and women).

  25. Proportion of patients with prolonged endocrine therapy [ Time Frame: 10 years ]
    Proportion of patients with EPclin "low risk" and "high risk" respectively who received an extended (> 5 years) endocrine therapy in all patients and separately for men and women).

  26. DMFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy [ Time Frame: 10 years ]
    Assessment of DMFS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

  27. DFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy [ Time Frame: 10 years ]
    Assessment of DFS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

  28. OS for patients with 5 years of endocrine therapy vs. extended endocrine therapy [ Time Frame: 10 years ]
    Assessment of OS according to EPclin / EP risk class for patients who have received an endocrine therapy for 5 years vs. patients who received an extended endocrine therapy (> 5 years).

  29. Correlation ( pT- and pN data vs. ciT and ciN-data) [ Time Frame: 1 year ]
    Assessment of the correlation between EPclin, that has been calculated with pT- (pathological tumor size) and pN (pathological nodal status) data and the EPclin based on ciT (clinical/ imaging tumor size) and ciN (clinical/imaging nodal status)-data (in all patients and separately for men and women).

  30. Concordance ( pT- and pN data vs. ciT and ciN-data) [ Time Frame: 1 year ]
    Assessment of the concordance between EPclin, that has been calculated with pT- and pN data and the EPclin based on ciT and ciN-data (in all patients and separately for men and women).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary stage I or Ii breast cancer who met all inclusin and no exclusion criteria
Criteria

Inclusion Criteria:

  1. Informed consent
  2. Tested with EndoPredict within the previous 3 months before inclusion
  3. Age ≥ 18 years
  4. Patients with primary invasive breast cancer, Stage I/II
  5. ER-positive
  6. HER2-negative
  7. N0 or N1 (1-3 positive lymph nodes)
  8. T1 - T3

Exclusion Criteria:

  1. Inflammatory breast cancer
  2. Bilateral breast cancer
  3. Breast cancer in the last 10 years
  4. Other invasive malignancies in the last 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503799


Contacts
Contact: Kristin Schnuppe, Dr. +49(0)30-450564056 Kristin.Schnuppe@charite.de
Contact: Maren Keller, Dr. +49(0)30-450564082 M.Keller@charite.de

Locations
Germany
Frauenklinik der Technischen Universität München Recruiting
München, Bayern, Germany, 81675
Contact: Johannes Ettl, Dr.    49(0)89-41402433    Johannes.Ettl@tum.de   
Contact: Evelyn Klein, Dr.    49(0)89-4140 2420    Evelyn.Klein@tum.de   
Ev. Waldkrankenhaus Not yet recruiting
Berlin, Germany, 13589
Contact: Björn Beurer, Dr.    +49 30 37022448    bjoern.beurer@pgdiakonie.de   
Contact: Jochem Potenberg, Dr.    +49 30 3702-2417    j.potenberg@waldkrankenhaus.com   
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Center for Clinical Trials Philipps University Marburg
Investigators
Principal Investigator: Johannes Ettl, Dr. Technischen Universität München (TUM) Lehrstuhl für Gynäkologie und Geburtshilfe

Publications:

Responsible Party: North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT03503799     History of Changes
Other Study ID Numbers: NOGGO B3
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
breast cancer
EndoPredict®
endocrine therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases