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

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ClinicalTrials.gov Identifier: NCT01815242
Recruitment Status : Active, not recruiting
First Posted : March 21, 2013
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
West German Study Group

Tracking Information
First Submitted Date  ICMJE March 18, 2013
First Posted Date  ICMJE March 21, 2013
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
  • Comparison: pCR in nab-paclitaxel/carboplatin vs. nab-paclitaxel/gemcitabine [ Time Frame: After 12 weeks of therapy ]
    pCR will be measured after 12 weeks of randomized treatment.
  • Comparison: pCR in responders vs. non-responders [ Time Frame: After 12 weeks of therapy ]
    pCR will be measured after 12 weeks of randomized treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Official Title  ICMJE Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Brief Summary The trial will evaluate the optimal treatment with nab-paclitaxel in combination with either carboplatin or gemcitabine for patients with triple negative breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: nab-Paclitaxel
  • Drug: Gemcitabine
  • Drug: Carboplatin
Study Arms  ICMJE
  • Experimental: Arm A
    nab-Paclitaxel + gemcitabine
    Interventions:
    • Drug: nab-Paclitaxel
    • Drug: Gemcitabine
  • Experimental: Arm B
    nab-Paclitaxel + carboplatin
    Interventions:
    • Drug: nab-Paclitaxel
    • Drug: Carboplatin
Publications *

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2013)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Actual Primary Completion Date March 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 10^9/L
    • Platelets >= 100 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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT01815242
Other Study ID Numbers  ICMJE WSG-AM06 / ADAPT TN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party West German Study Group
Study Sponsor  ICMJE West German Study Group
Collaborators  ICMJE Celgene
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 July 2019

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