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Trial record 1 of 1 for:    NCT01815242
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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 : June 19, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
West German Study Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 - Triple Negative Breast Cancer
Study Start Date : June 2013
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A
nab-Paclitaxel + gemcitabine
Drug: nab-Paclitaxel
Drug: Gemcitabine
Experimental: Arm B
nab-Paclitaxel + carboplatin
Drug: nab-Paclitaxel
Drug: Carboplatin



Primary Outcome Measures :
  1. 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.

  2. Comparison: pCR in responders vs. non-responders [ Time Frame: After 12 weeks of therapy ]
    pCR will be measured after 12 weeks of randomized treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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 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

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): NCT01815242


Locations
Germany
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
Moenchengladbach, Germany, 41061
Sponsors and Collaborators
West German Study Group
Celgene Corporation
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

Publications:
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT01815242     History of Changes
Other Study ID Numbers: WSG-AM06 / ADAPT TN
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs