Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005203

Trial Description

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Title

Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

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Trial Acronym

ADAPT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Trial for the optimization of risk assessment and therapy success prediction in patients
with early breast cancer by the use of biomarkers in advance to therapy decision-making to
personalize therapies.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005203
  •   2013/09/06
  •   2013/01/25
  •   yes
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Secondary IDs

  •   NCT01781338  (ClinicalTrials.gov)
  •   WSG-AM06 / ADAPT  (West German Study Group)
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Other: Induction therapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   Single (group)
  •   II-III
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Primary Outcome

- Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11; time frame: 8 years; In order to identify patients that are at comparable low risk as hormone receptor positive, HER2 negative patients with low Recurrence Score, any sub-population across the sub-trials will be compared to this risk group.

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Secondary Outcome

- Overall survival; time frame: 8 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

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  •   2012/05/31
  •   4936
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- Female patients, age at diagnosis 18 - 75 years

- Histologically confirmed unilateral primary invasive carcinoma of the breast

- Clinical T1 - T4 (except inflammatory breast cancer)

- All clinical N (cN)

- No clinical evidence for distant metastasis (M0)

- Known HR status and HER2 status (local pathology)

- Tumor block available for central pathology review

- Performance Status ECOG <= 1 or KI >= 80%

- Negative pregnancy test (urine or serum) within 7 days prior to start of induction
treatment in premenopausal patients

- Written informed consent prior to beginning specific protocol procedures, including
expected cooperation of the patients for the treatment and follow-up, must be
obtained and documented according to the local regulatory requirements

- The patient must be accessible for treatment and follow-up

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Exclusion Criteria

- Known hypersensitivity reaction to the compounds or incorporated substances

- Prior malignancy with a disease-free survival of < 10 years, except curatively
treated basalioma of the skin or pTis of the cervix uteri

- Non-operable breast cancer including inflammatory breast cancer

- Previous or concurrent treatment with cytotoxic agents for any reason after
consultation with the sponsor

- Concurrent treatment with other experimental drugs. Participation in another
interventional clinical trial with or without any investigational not marketed drug
within 30 days prior to study entry

- Male breast cancer

- Concurrent pregnancy; patients of childbearing potential must implement a highly
effective (less than 1% failure rate) non-hormonal contraceptive measures during the
study treatment

- Breast feeding woman

- Sequential breast cancer

- Reasons indicating risk of poor compliance

- Patients not able to consent

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Addresses

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    • West German Study Group
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    • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
    • Nadia Harbeck, Prof. Dr. 
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    • Daniel Hofmann, M. Sc. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2013/10/20
* This entry means the parameter is not applicable or has not been set.