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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by West German Study Group
Sponsor:
Information provided by (Responsible Party):
West German Study Group
ClinicalTrials.gov Identifier:
NCT01779206
First received: January 25, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Paclitaxel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by West German Study Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4936
Study Start Date: May 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779206

Contacts
Contact: Daniel Hofmann, M.Sc. +49216156623 ext 17 daniel.hofmann@wsg-online.com
Contact: Sebastian Räth, PhD +49308868688 ext 13 sebastian.raeth@wsg-online.com

Locations
Germany
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern Recruiting
Munich, Bavaria, Germany, 81377
Contact: Nadia Harbeck, Prof. Dr.    +49897095 ext 4531    nadia.harbeck@med.uni-muenchen.de   
Principal Investigator: Nadia Harbeck, Prof. Dr.         
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein Recruiting
Mönchengladbach, NRW, Germany, 41061
Contact: Ulrike Nitz, Prof. Dr.    +492161981 ext 2330    ulrike.nitz@wsg-online.com   
Principal Investigator: Raquel von Schumann         
Sponsors and Collaborators
West German Study Group
Investigators
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
  More Information

Publications:
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT01779206     History of Changes
Other Study ID Numbers: WSG-AM06 / ADAPT HR+/HER2-
Study First Received: January 25, 2013
Last Updated: July 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Paclitaxel
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014