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Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP)

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ClinicalTrials.gov Identifier: NCT01746225
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : May 31, 2017
Sponsor:
Collaborator:
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date May 31, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
Efficacy of nab-Paclitaxel schedules [ Time Frame: At the end of the third induction cycle and during maintenance nab-Paclitaxel every three months until PD (an expected average of nine months) ]
Disease response and progression will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST V 1.1) Patients may have measurable or non-measurable disease. CT can is the method to measure lesion.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
Efficacy of nab-Paclitaxel schedules [ Time Frame: At the end of the third induction cycle and during maintenace nab-Paclitaxel every three months until PD (an expected average of nine months) ]
Disease response and progression will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST V 1.1) Patients may have measurable or non-measurable disease. CT can is the method to measure lesion.
Change History Complete list of historical versions of study NCT01746225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • Tolerability, feasibility, disease response and OS of nab-Paclitaxel schedules [ Time Frame: Targeted AEs at the end of each cycle and hematology days 1, 8, 15, 22 according to treatment arm ]
    Determination of targeted adverse events (AE), performance status, hematological/ biochemical examinations and physical exams are used to evaluate tolerability and feasibility, vital signs for overall survival (OS).
  • Quality of life [ Time Frame: QL self-assessment once each months until PD (maximal twelve months, expected average of nine months) and at end-of-treatment visit ]
    To explore the changes in quality of life (QL) over time until treatment discontinuation.
  • Prognostic biomarker analysis [ Time Frame: SPARC and caveolin expressions will be determined in FFPE (formalin fixed paraffin embedded) samples from primary tumor (obtained 14 days prior to randomization) and from FFPE sample of metastatic biopsy at PD (an expected average of nine months) ]
    To investigate the prognostic role of putative markers (SPARC and caveolin) and assess any change in the expression of SPARC and caveolin between primary and the metastatic sites.
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 Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
Official Title  ICMJE A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial)
Brief Summary

Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting.

The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy.

The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breastcancer
Intervention  ICMJE Drug: nab-Paclitaxel
Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
Other Name: Abraxane
Study Arms
  • Experimental: nab-Paclitaxel 150 mg/m2 days 1,15
    Arm A: Induction nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
    Intervention: Drug: nab-Paclitaxel
  • Experimental: nab-Paclitaxel 100 mg/m2 days 1,8,15
    Arm B: Induction nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
    Intervention: Drug: nab-Paclitaxel
  • Experimental: nab-Paclitaxel 75 mg/m2 days 1,8,15,22
    Arm C: Induction nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.
    Intervention: Drug: nab-Paclitaxel
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
Actual Enrollment  ICMJE
 (submitted: February 13, 2015)
258
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
240
Estimated Study Completion Date April 2023
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed HER2-negative metastatic (stage IV) breast cancer.
  • Measurable or non-measurable, but radiologically evaluable, disease according to RECIST 1.1 criteria.
  • Female aged 18 years or older.
  • Life expectancy > 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Either ER-positive or ER-negative disease. Patients with ER-positive disease must be endocrine resistant, defined as having failed at least one prior endocrine therapy for breast cancer, or must be candidates for first-line chemotherapy.
  • If previously treated with a taxane or anthracycline in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
  • Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
  • Normal hematologic status.
  • Normal renal function.
  • Normal liver function.
  • Normal cardiac function.
  • Women of childbearing potential: documented negative pregnancy test within 2 weeks prior to randomization, and acceptable birth control during the duration of the trial therapy and for a period of 6 months following the last administration of study drug.
  • Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
  • Completed baseline Quality of Life Form.
  • The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
  • Availability of an formalin fixed paraffin embedded (FFPE) block from the primary tumor (breast lesion) for submission to central pathology review and for translational research.
  • Written consent to pathology material submission, signed and dated by the patient and the Investigator prior to randomization.

Exclusion Criteria:

  • Any prior chemotherapy for metastatic breast cancer.
  • Presence of central nervous system (CNS) metastasis.
  • Peripheral neuropathy grade 2 or higher (CTCAE version 4).
  • Significant uncontrolled cardiac disease (i.e. unstable angina, recent myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
  • Pregnant or lactating.
  • Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
  • Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
  • Contraindications or known hypersensitivity to the study medication or excipients.
  • The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
  • Inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator.
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 Belgium,   Ireland,   Italy,   Slovenia,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01746225
Other Study ID Numbers  ICMJE IBCSG 42-12 / BIG 2-12
2012-003058-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party International Breast Cancer Study Group
Study Sponsor  ICMJE International Breast Cancer Study Group
Collaborators  ICMJE Breast International Group
Investigators  ICMJE
Study Chair: Alessandra Gennari, MD Division of Medical Oncology, E.O. Galliera, Genoa, Italy
Study Chair: Guy Jerusalem, MD, PhD CHU Sart Tilman and University of Liège, Liège, Belgium
PRS Account International Breast Cancer Study Group
Verification Date May 2017

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