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Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00053898
Recruitment Status : Completed
First Posted : February 6, 2003
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Southwest Oncology Group
American College of Surgeons
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: anastrozole
Drug: tamoxifen citrate
Radiation: Radiation Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: Tamoxifen + Anastrozole Placebo

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

tamoxifen citrate: 20 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy

Group 2: Anastrozole + Tamoxifen Placebo

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

anastrozole: 1 mg/day and placebo for 5 years

Radiation Therapy: Adjuvant radiation therapy


Participant Flow:   Overall Study
    Group 1: Tamoxifen + Anastrozole Placebo   Group 2: Anastrozole + Tamoxifen Placebo
STARTED   1552   1552 
COMPLETED   1538   1539 
NOT COMPLETED   14   13 
No follow-up data from any source                9                12 
Follow-up from telephone contact only                5                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1: Tamoxifen + Anastrozole Placebo

tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years

Drug: tamoxifen citrate

20 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

Group 2: Anastrozole + Tamoxifen Placebo

anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years

Drug: anastrozole

1 mg/day and placebo for 5 years

Radiation: Radiation Therapy

Adjuvant radiation therapy

Total Total of all reporting groups

Baseline Measures
   Group 1: Tamoxifen + Anastrozole Placebo   Group 2: Anastrozole + Tamoxifen Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1552   1552   3104 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (7.8)   61.1  (7.8)   61.0  (7.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1552 100.0%      1552 100.0%      3104 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Percentage of Patients Free From Breast Cancer   [ Time Frame: 10 years ]

2.  Secondary:   Percentage of Patients Free From Invasive Breast Cancer   [ Time Frame: 10 years ]

3.  Secondary:   Percentage of Patients Free From Ipsilateral Recurrence   [ Time Frame: 10 years ]

4.  Secondary:   Percentage of Patients Free From Contralateral Breast Cancer   [ Time Frame: 10 years ]

5.  Secondary:   Percentage of Patients Free From Non-breast Secondary Cancer   [ Time Frame: 10 years ]

6.  Secondary:   Percentage of Patients Free From Osteoporotic Fractures   [ Time Frame: 10 years ]

7.  Secondary:   Percentage of Patients Alive and Disease-free   [ Time Frame: 10 years ]

8.  Secondary:   Percentage of Patients Alive (Overall Survival)   [ Time Frame: 10 years ]

9.  Secondary:   Quality of Life   [ Time Frame: 5 years ]

10.  Secondary:   Quality-adjusted Survival Time   [ Time Frame: baseline and every 6 month for 6 years ]
Results not yet reported.   Anticipated Reporting Date:   09/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Department of Regulatory Affairs
Organization: NSABP Foundation, Inc
phone: 412-339-5300
e-mail: regulatory@nsabp.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00053898     History of Changes
Other Study ID Numbers: NSABP B-35
NSABP-B-35
SWOG-NSABP-B-35
NCCTG-NSABP-B-35
ACOSOG-NSABP-B-35
First Submitted: February 5, 2003
First Posted: February 6, 2003
Results First Submitted: November 20, 2017
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018