NCT01471106

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Version 4 to 5 · M.D. Anderson Cancer Center

Patch inspector

Version 4 to 5

6 operations 2 path groups ctgov_internal_history

Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.

Plain-language summary

Manual review pending.

Rules fired

None recorded.

Value signals

[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": null,
    "old_type": null,
    "severity": "medium",
    "direction": "later",
    "new_value": "2014-03",
    "old_value": "2013-12",
    "delta_days": 90,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2018-03",
    "old_value": "2017-12",
    "delta_days": 90,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 19:11:12+00
Raw hash: 57374e3270f7d9ee3ec006cfeffc052b4dab554c1c86187e4292dd5658181b61
Payload: Source URL

Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops

replace /protocolSection/statusModule/startDateStruct/date

Triage: Medium

Timeline Shift Operation 2

Matched rules

start_timeline_change Start date changes are operational timeline signals.

Before

2013-12

After

2014-03

replace /protocolSection/statusModule/primaryCompletionDateStruct/date

Triage: Medium

Timeline Shift Operation 3

Matched rules

primary_completion_timeline_change Primary completion date changes are operational timeline signals.

Before

2017-12

After

2018-03

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops

replace /protocolSection/statusModule/statusVerifiedDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2013-07

After

2013-12

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 4

Before

2013-07-30

After

2013-12-27

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 5

Before

2013-07-31

After

2013-12-31

replace /protocolSection/descriptionModule/detailedDescription

Triage: Uncategorized

Uncategorized Operation 6

Before

<p>Study Drug Administration:</p><p>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</p><ul><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.
In the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li><li>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
You will also be asked to review your drug diary.
This call will take about 20 minutes</li></ul><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.
Biomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.
Dasatinib is FDA approved and commercially available for the treatment of leukemia.
Its use in breast cancer patients in investigational.</p><p>Up to 66 patients will take part in this multicenter study.
Up to 60 will be enrolled at MD Anderson.</p>

After

<p>Study Drug Administration:</p><p>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</p><ul><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.
In the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li><li>You will have an electrocardiogram (EKG) to check your heart function.f</li></ul><p>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.
You will also be asked to review your drug diary.
This call will take about 20 minutes</p><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.
Biomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.
Dasatinib is FDA approved and commercially available for the treatment of leukemia.
Its use in breast cancer patients in investigational.</p><p>While you are on study, dasatinib will be provided at no cost to you if you receive it.</p><p>Up to 66 patients will take part in this multicenter study.
Up to 60 will be enrolled at MD Anderson.</p>

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2013-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2014-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2018-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2013-12-27"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2013-12-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>Study Drug Administration:</p><p>If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 study groups:</p><ul><li>If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.</li><li>If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.</li><li>If you are in Group 3, you will not receive dasatinib.</li></ul><p>You will be given a study drug diary to complete.\nIn the diary, you will record when you take the study drug.</p><p>Study Visits:</p><p>At Month 1:</p><ul><li>Blood (about 2 tablespoons) will be drawn for routine tests.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li><li>You will have an electrocardiogram (EKG) to check your heart function.f</li></ul><p>At Month 2 you will be called by a nurse and asked about any drugs you are taking and side effects you may be having.\nYou will also be asked to review your drug diary.\nThis call will take about 20 minutes</p><p>At Month 3 (or if you leave the study early):</p><ul><li>You will have a fine needle aspirate (FNA) of the breast for biomarker testing.\nBiomarkers are found in the blood&#x2F;tissue and may be related to your reaction to the study drug.</li><li>Blood (about 2-3 tablespoons) will be drawn for biomarker testing.</li><li>You will be asked about any drugs you may be taking and side effects you may be having.</li><li>Your drug diary will be reviewed.</li></ul><p>Length of Study:</p><p>You may remain on study for up to 3 months.\nYou will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.</p><p>This is an investigational study.\nDasatinib is FDA approved and commercially available for the treatment of leukemia.\nIts use in breast cancer patients in investigational.</p><p>While you are on study, dasatinib will be provided at no cost to you if you receive it.</p><p>Up to 66 patients will take part in this multicenter study.\nUp to 60 will be enrolled at MD Anderson.</p>"
  }
]