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Old 12-03-2013, 04:01 PM   #1
'lizbeth
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Post DCIS & Herceptin /Radiation study

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

This study is currently recruiting participants.
Verified October 2013 by National Cancer Institute (NCI)
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:
NCT00769379
First received: October 8, 2008
Last updated: October 7, 2013
Last verified: October 2013
History of Changes


Purpose This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.


Condition Intervention Phase Ductal Breast Carcinoma in Situ
Biological: trastuzumab
Radiation: radiation therapy
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment Official Title: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time from randomization to ipsilateral invasive breast cancer, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (DCIS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Time to IIBCR-SCR-DCIS will be compared across treatment arms using cumulative incidence curves, Cox proportional hazard models, and the Kaplan-Meier method.



Secondary Outcome Measures:
  • Invasive or DCIS disease-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Events for analysis of IDFS-DCIS include: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous and basal cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the colon and cervix), or death from any cause prior to recurrence or second primary cancer. Invasive breast cancer, ipsilateral recurrence, and contralateral breast cancer will be compared across treatment arms using cumulative incidence functions.

  • Invasive or DCIS recurrence-free interval (IRFI-DCIS) [ Time Frame: Time from randomization to first diagnosis of a local, regional or distant recurrence regardless of any intervening contralateral or other second primary cancer, assessed up to 10 years ] [ Designated as safety issue: No ]Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.

  • Invasive regional or distant recurrence [ Time Frame: Time from randomization to first diagnosis of regional or distant recurrence, assessed up to 10 years ] [ Designated as safety issue: No ]Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.

  • Contralateral breast cancer (invasive or DCIS) [ Time Frame: Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years ] [ Designated as safety issue: No ]Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.

  • Overall survival (OS) [ Time Frame: Time from randomization to death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.

  • Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry [ Time Frame: 18 months ] [ Designated as safety issue: No ]Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration.



Estimated Enrollment: 2000 Study Start Date: November 2008



http://clinicaltrials.gov/ct2/show/N...o_unk=Y&rank=1
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