NCT01224678

Vitamin D and Breast Cancer Biomarkers in Female Patients

Version 42 to 43 · Alliance for Clinical Trials in Oncology

Patch inspector

Version 42 to 43

6 operations 3 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

eligibility_criteria_change

Value signals

None recorded.

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 19:14:40+00
Raw hash: 75e5b8e15a9feb1020b004d32d6df3346df230d2c45c831e657f7c62cb6280bb
Payload: Source URL

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 4

Matched rules

eligibility_criteria_change Eligibility criteria changes can alter the studied population.

Before

<p>DISEASE CHARACTERISTICS:</p><ul><li>Women with breast density ≥ 25% (correlating with the BIRAD-2 category of &quot;scattered fibroglandular densities&quot; or greater)</li><li>Hormone receptor status not specified</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li><p>Premenopausal defined as meeting at least one of the following criteria:</p><ul><li>Have regular menstrual cycles</li><li>Have had at least four cycles in the last six months</li><li>Have had a hysterectomy with ovaries intact and FSH level &lt; 20 IU&#x2F;L</li></ul></li><li>Calcium &lt; 10.5 mg&#x2F;dL</li><li>Not pregnant</li><li>Fertile patients must use effective contraception</li><li>Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible</li><li>Patients with two or more bone fractures in the past five years are not eligible</li><li>Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible</li><li>Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible</li><li>Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li><p>Patients who are currently receiving hormone replacement therapy (estrogen or progesterone) or are taking tamoxifen or raloxifene are not eligible</p><ul><li>Women who have taken these medications must have stopped for at least 4 months prior to study entry</li><li>Topical estrogen is allowed</li></ul></li><li>Patients who regularly use (≥ 2 x per week) oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, or rifampin are not eligible</li><li>Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry</li><li><p>Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible</p><ul><li>Women who agree to stop will need to do so for at least 6 months prior to registration</li></ul></li><li>Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram</li><li>Patients participating in a concurrent breast cancer chemoprevention trial are not eligible</li><li>No history of breast implants or breast reduction</li></ul>

After

<p>DISEASE CHARACTERISTICS:</p><ul><li>Women with breast density ≥ 25% (correlating with the BIRAD-2 category of &quot;scattered fibroglandular densities&quot; or greater)</li><li>Hormone receptor status not specified</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li><p>Premenopausal defined as meeting at least one of the following criteria:</p><ul><li>Have regular menstrual cycles</li><li>Have had at least four cycles in the last six months</li><li>Have had a hysterectomy with ovaries intact and FSH level &lt; 20 IU&#x2F;L</li></ul></li><li>Calcium &lt; 10.5 mg&#x2F;dL</li><li>Not pregnant</li><li>Fertile patients must use effective contraception</li><li>Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible</li><li>Patients with two or more bone fractures in the past five years are not eligible</li><li>Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible</li><li>Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible</li><li>Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li><p>Patients who are currently receiving hormone replacement therapy (estrogen or progesterone) or are taking tamoxifen or raloxifene are not eligible</p><ul><li>Women who have taken these medications must have stopped for at least 4 months prior to study entry</li><li>Topical estrogen is allowed</li></ul></li><li>Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry</li><li><p>Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible</p><ul><li>Women who agree to stop will need to do so for at least 6 months prior to registration</li></ul></li><li>Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram</li><li>Patients participating in a concurrent breast cancer chemoprevention trial are not eligible</li><li>No history of breast implants or breast reduction</li></ul>

Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 2 ops

remove /protocolSection/contactsLocationsModule/locations/8

Triage: Uncategorized

Uncategorized Operation 5

Before

{
  "zip": "94806",
  "city": "San Pablo",
  "state": "California",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "James H. Feusner, MD",
      "role": "CONTACT",
      "phone": "510-428-3689"
    }
  ],
  "facility": "Doctors Medical Center - San Pablo Campus",
  "geoPoint": {
    "lat": 37.96215,
    "lon": -122.34553
  }
}

remove /protocolSection/contactsLocationsModule/locations/79

Triage: Uncategorized

Uncategorized Operation 6

Before

{
  "zip": "27103",
  "city": "Winston-Salem",
  "state": "North Carolina",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Clinical Trials Office - Forsyth Regional Cancer Center at For",
      "role": "CONTACT",
      "phone": "336-277-8887"
    }
  ],
  "facility": "Forsyth Regional Cancer Center at Forsyth Medical Center",
  "geoPoint": {
    "lat": 36.09986,
    "lon": -80.24422
  }
}

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops

replace /protocolSection/statusModule/statusVerifiedDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2012-01

After

2012-02

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 2

Before

2012-02-01

After

2012-02-05

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 3

Before

2012-02-02

After

2012-02-07

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2012-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2012-02-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2012-02-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>DISEASE CHARACTERISTICS:</p><ul><li>Women with breast density ≥ 25% (correlating with the BIRAD-2 category of &quot;scattered fibroglandular densities&quot; or greater)</li><li>Hormone receptor status not specified</li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li><p>Premenopausal defined as meeting at least one of the following criteria:</p><ul><li>Have regular menstrual cycles</li><li>Have had at least four cycles in the last six months</li><li>Have had a hysterectomy with ovaries intact and FSH level &lt; 20 IU&#x2F;L</li></ul></li><li>Calcium &lt; 10.5 mg&#x2F;dL</li><li>Not pregnant</li><li>Fertile patients must use effective contraception</li><li>Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible</li><li>Patients with two or more bone fractures in the past five years are not eligible</li><li>Patients with a diagnosis of osteoporosis with physician recommendation for treatment of low bone mass are not eligible</li><li>Patients known to have hyperparathyroid disease or other serious disturbances of calcium metabolism requiring intervention in the past 5 years are not eligible</li><li>Patients with a history of kidney stones (unless documented not to have been a calcium stone) are not eligible</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li><p>Patients who are currently receiving hormone replacement therapy (estrogen or progesterone) or are taking tamoxifen or raloxifene are not eligible</p><ul><li>Women who have taken these medications must have stopped for at least 4 months prior to study entry</li><li>Topical estrogen is allowed</li></ul></li><li>Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry</li><li><p>Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible</p><ul><li>Women who agree to stop will need to do so for at least 6 months prior to registration</li></ul></li><li>Patients may not start vitamin D supplementation after registration (regardless of results of vitamin D testing) but they may continue vitamin D if they are already taking 400 IUs daily or less and have been taking vitamin D for at least 6 months prior to baseline mammogram</li><li>Patients participating in a concurrent breast cancer chemoprevention trial are not eligible</li><li>No history of breast implants or breast reduction</li></ul>"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/8"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/79"
  }
]