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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

Breast

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Unique Dataset IDnci-data-353ClinicalTrial.gov IDNCT00003857
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients636RandomizationYesPubMed (PMID)25605856.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeSurgery, Targeted Therapy, Drug, RadiationDataset TypeOther

Clinical Trial Title

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. Compare distant disease-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.

Outcome Measures

Primary: Local recurrence (e.g., invasive or noninvasive recurrence) [ Time Frame: From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Secondary: Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Time to distant metastasis [ Time Frame: From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Invasive local recurrence [ Time Frame: From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Salvage mastectomy rate [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This dataset will allow users to reproduce the treatment comparison between Arm 1 and Arm 2 in trial NCT00003857.

Available Downloads: NCT00003857-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00003857-D1-Data-Dictionary.pdf

DATA: NCT00003857-D1-Dataset.csv

OTHER: README.pdf