Vitamin D and Breast Cancer Biomarkers in Female Patients

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2016-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2016-06-17"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2016-06-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/phases/0",
    "value": "PHASE3"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Change (between baseline and year 1) in tissue biomarker (atypia) compared between arms"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Change (between baseline and year 1) in tissue biomarker (Ki67) compared between arms"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
    "value": {
      "measure": "Change (between baseline and year 1) in breast cancer biomarker (density) compared between arms",
      "timeFrame": "Up to 12 months"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "value": {
      "measure": "Change (between baseline and year 1) in breast cancer biomarker (IGF1) compared between arms",
      "timeFrame": "Up to 12 months"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "value": {
      "measure": "Change (between baseline and year 1) in breast cancer biomarkers (atypia) compared between arms",
      "timeFrame": "Up to 12 months"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6",
    "value": {
      "measure": "Change (between baseline and year 1) in breast cancer biomarkers (Ki67) compared between arms",
      "timeFrame": "Up to 12 months"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7",
    "value": {
      "measure": "Reported time spent outside as assessed using the Sunlight Questionnaire",
      "timeFrame": "Up to 12 month"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8",
    "value": {
      "measure": "Change (between baseline and year 1) in breast density measurements",
      "timeFrame": "Up to 12 months"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<ol><li>Premenopausal women 55 years of age or younger with regular menstrual cycles (at least four cycles in the last six months).\nWomen with fewer than 4 menses in the last 6 months or who have had a hysterectomy with ovaries intact will be considered premenopausal if FSH level &lt; 20.</li><li>Women with breast density ≥ 25% (scattered fibroglandular densities or greater) are eligible.</li><li><p>Prior Treatment</p><ol><li><p>Patients who are currently receiving hormone replacement therapy (estrogen or progesterone); or are taking tamoxifen or raloxifene are not eligible.\nWomen who have taken these medications must have stopped for at least 4 months prior to study entry.</p><p>Topical estrogen (eg, transdermal patches and vaginal estrogens) is allowed.</p></li><li>Patients who are currently using hormonal contraception, should be taking it for at least 4 months prior to study entry.</li></ol></li><li><p>Vitamin D Use</p><ol><li>Patients who are taking regular vitamin D supplementation (above 400 IUs daily) and refuse or are unable to stop use are not eligible.\nWomen who agree to stop will need to do so for at least 6 months prior to registration.</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></ol></li><li>Patients with a history of breast cancer (including DCIS) or ovarian cancer are not eligible.</li><li>Patients with a history of breast implants or breast reduction 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><li>Patients participating in a concurrent breast cancer chemoprevention trial are not eligible.</li><li>Required initial laboratory values - Calcium &lt; 10.5 mg&#x2F;dL</li></ol>"
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          "unpostedEvents": [
            {
              "date": "2017-03-06",
              "type": "RELEASE"
            },
            {
              "date": "2017-04-14",
              "type": "RESET"
            },
            {
              "date": "2017-05-16",
              "type": "RELEASE"
            },
            {
              "date": "2017-07-28",
              "type": "RESET"
            }
          ],
          "unpostedResponsibleParty": "Alliance for Clinical Trials in Oncology"
        }
      }
    }
  }
]