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← PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Breast cancer (adjuvant) after prior therapy

NCT01159067 · STUDY IN CONTEXT

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)

Source null

→

secondary · POSTED

In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens.

No patient had elevated LPI level above 0.5umol/L at baseline.

→

secondary · POSTED

Number of patients, whose Serum Ferritin levels are lower than 1500 ng/mL at two consecutive study visits. Serum Ferritin levels are measured at screening (baseline), week 4, 8, 12, 16, 20, 24 and end of study.

Source null

→

secondary · POSTED

Both LPI and Serum Ferritin levels are measured at screening (baseline), week 4, 12, 24 and end of study. The correlation between the levels of LPI and Serum Ferritin at screening, week 4, 12, 24 and end of study will be examined and plotted.

The enrolled patient's LPI level at baseline is below 0.5 umol/L and she had both LPI and Serum Ferritin levels measured at baseline only. Therefore, no sufficient data to estimate the correlation of LPI with Serum Ferritin.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
nct id
NCT01159067
trial label
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0000
    source section id
    NCT01159067-om-0000
    source outcome index
    0
    endpoint
    Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
    endpoint definition
    Number of Patients With Elevated Labile Plasma Iron (LPI) Above Threshold (0.5 Umol/L)
    time origin
    At baseline
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0001
    source section id
    NCT01159067-om-0001
    source outcome index
    1
    endpoint
    Number of Patients With LPI Below 0.5 Umol/L After Treatment
    endpoint definition
    In patients with LPI values above threshold 0.5umol/L at baseline, number of patients had LPI suppressed below this value after treatment. Measurement of LPI is done on plasma specimens.
    time origin
    Assessed through 6 months from the start of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No patient had elevated LPI level above 0.5umol/L at baseline.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0002
    source section id
    NCT01159067-om-0002
    source outcome index
    2
    endpoint
    Number of Patients With Serum Ferritin Level Lower Than 1500 ng/mL After Treatment
    endpoint definition
    Number of patients, whose Serum Ferritin levels are lower than 1500 ng/mL at two consecutive study visits. Serum Ferritin levels are measured at screening (baseline), week 4, 8, 12, 16, 20, 24 and end of study.
    time origin
    Assessed through 6 months from the start of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0003
    source section id
    NCT01159067-om-0003
    source outcome index
    3
    endpoint
    Correlation of LPI With Serum Ferritin
    endpoint definition
    Both LPI and Serum Ferritin levels are measured at screening (baseline), week 4, 12, 24 and end of study. The correlation between the levels of LPI and Serum Ferritin at screening, week 4, 12, 24 and end of study will be examined and plotted.
    time origin
    Assessed through 6 months from the start of treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The enrolled patient's LPI level at baseline is below 0.5 umol/L and she had both LPI and Serum Ferritin levels measured at baseline only. Therefore, no sufficient data to estimate the correlation of LPI with Serum Ferritin.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01159067-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01159067-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01159067-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I
    regimen
    Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01159067-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
    nct id
    NCT01159067
    harm key
    EG000
    source section id
    NCT01159067-ae
    event group key
    EG000
    event group label
    Arm I
    serious affected
    0
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    From Cycle 1 to Cycle 6
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice