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Trial record 1 of 1 for:    NCT01779206
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ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)

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ClinicalTrials.gov Identifier: NCT01779206
Recruitment Status : Unknown
Verified May 2015 by West German Study Group.
Recruitment status was:  Recruiting
First Posted : January 30, 2013
Last Update Posted : May 19, 2015
Sponsor:
Information provided by (Responsible Party):
West German Study Group

Tracking Information
First Submitted Date  ICMJE January 25, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 [ Time Frame: 3 Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01779206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
Overall survival [ Time Frame: 3 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Official Title  ICMJE Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Epirubicin
  • Drug: Cyclophosphamide
  • Drug: Docetaxel
  • Drug: Paclitaxel
Study Arms
  • Active Comparator: Anthracycline - Taxane
    Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Paclitaxel
  • Experimental: Taxane - Anthracycline
    Study sites can choose between either Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q3w OR Epirubicin (90mg/m²) Cyclophosphamide (600mg/m²) q2w for anthracycline treatment and between either 4 x Docetaxel (100mg/m²) q3w OR 12 x Paclitaxel (80mg/m²) q1w for taxane treatment.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cyclophosphamide
    • Drug: Docetaxel
    • Drug: Paclitaxel
Publications * Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)
4936
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
  • 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

Additional Inclusion criteria for patients receiving chemotherapy:

  • Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14 days prior to induction treatment):

    • Leucocytes >= 3.5 x 10^9/L
    • Platelets >= 100 x 10^9/L
    • Hemoglobin >= 10 g/dL
    • Total bilirubin <= 1 x ULN
    • ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL
    • Creatinine <= 175 µmol/L (2 mg/dl)
  • LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

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

Additional Exclusion Criteria for patients receiving chemotherapy:

  • Known polyneuropathy ≥ grade 2
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease
  • Uncompensated cardiac function
  • Inadequate organ function including:

    • Leucocytes < 3.5 x 10^9/l
    • Platelets < 100 x 10^9/l
    • Bilirubin above normal limits
    • Alkaline phosphatase >= 5 x UNL
    • ASAT and/or ALAT associated with AP > 2.5 x UNL
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779206
Other Study ID Numbers  ICMJE WSG-AM06 / ADAPT HR+/HER2-
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party West German Study Group
Study Sponsor  ICMJE West German Study Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadia Harbeck, Prof. Dr. Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Study Chair: Ulrike Nitz, Prof. Dr. Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
PRS Account West German Study Group
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP