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Trial record 1 of 1 for:    mehta AND fulvestrant
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S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00075764
First Posted: January 13, 2004
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: October 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: anastrozole
Drug: fulvestrant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

707 Patients underwent randomization. 12 were excluded: 9 did not have metastatic disease, 1 had previous chemotherapy, 1 was estrogen-receptor and progesterone-receptor negative, 1 did not undergo chest imaging. In addition, 1 patient withdrew consent.

694 patients were included in the analysis.


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
Arm I Anastrozole

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Arm II Anastrozole and Fulvestrant

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly


Participant Flow:   Overall Study
    Arm I Anastrozole   Arm II Anastrozole and Fulvestrant
STARTED   345   349 
COMPLETED   0   0 
NOT COMPLETED   345   349 
Adverse Event                5                12 
Death                4                8 
Withdrawal by Subject                28                18 
Progression                269                274 
Still on treatment                8                15 
Delinquent                4                2 
Not protocol specified                27                19 
Under review                0                1 



  Baseline Characteristics
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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
Arm I Anastrozole

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Arm II Anastrozole and Fulvestrant

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Total Total of all reporting groups

Baseline Measures
   Arm I Anastrozole   Arm II Anastrozole and Fulvestrant   Total 
Overall Participants Analyzed 
[Units: Participants]
 345   349   694 
Age 
[Units: Years]
Median (Full Range)
     
Participants Analyzed 
[Units: Participants]
 345   349   694 
   65 
 (36 to 91) 
 65 
 (27 to 92) 
 65 
 (27 to 92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 345   349   694 
Female      345 100.0%      349 100.0%      694 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Prior adjuvant tamoxifen 
[Units: Participants]
     
Yes       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Yes   139   141   280 
No       
Participants Analyzed 
[Units: Participants]
 345   349   694 
No   206   208   414 
Prior adjuvant chemotherapy 
[Units: Participants]
     
Yes       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Yes   103   129   232 
No       
Participants Analyzed 
[Units: Participants]
 345   349   694 
No   242   220   462 
Measurable disease 
[Units: Participants]
     
Yes       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Yes   188   188   376 
No       
Participants Analyzed 
[Units: Participants]
 345   349   694 
No   157   161   318 
Disease site 
[Units: Participants]
     
Bone only       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Bone only   76   75   151 
Visceral       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Visceral   167   181   348 
Nonvisceral       
Participants Analyzed 
[Units: Participants]
 345   349   694 
Nonvisceral   102   93   195 
Time between diagnosis of primary and metastatic disease [1] 
[Units: Participants]
     
None       
Participants Analyzed 
[Units: Participants]
 337   339   676 
None   141   122   263 
3 mo to < 5 yr       
Participants Analyzed 
[Units: Participants]
 337   339   676 
3 mo to < 5 yr   40   47   87 
5 to < 10 yr       
Participants Analyzed 
[Units: Participants]
 337   339   676 
5 to < 10 yr   68   66   134 
>= 10 yr       
Participants Analyzed 
[Units: Participants]
 337   339   676 
>= 10 yr   88   104   192 
[1] Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
HER2 status [1] [2] 
[Units: Participants]
     
Positive       
Participants Analyzed 
[Units: Participants]
 295   297   592 
Positive   25   31   56 
Negative       
Participants Analyzed 
[Units: Participants]
 295   297   592 
Negative   270   266   536 
[1] HER2 denotes human epidermal growth factor receptor type 2.
[2] Only patients with available HER2 status data will be included in the analysis.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Tumor Progression   [ Time Frame: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first. ]

2.  Secondary:   Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).   [ Time Frame: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first. ]

3.  Secondary:   Overall Survival   [ Time Frame: Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first. ]

4.  Secondary:   Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs   [ Time Frame: Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Breast Committee Statistician
Organization: SWOG
phone: 206-667-4623


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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00075764     History of Changes
Other Study ID Numbers: CDR0000349337
U10CA032102 ( U.S. NIH Grant/Contract )
S0226 ( Other Identifier: SWOG )
CAN-NCIC-MAC7 ( Other Identifier: NCIC-CTG )
First Submitted: January 9, 2004
First Posted: January 13, 2004
Results First Submitted: October 26, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017