Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00390455
First received: October 18, 2006
Last updated: June 1, 2015
Last verified: January 2015
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Estrogen Receptor Positive
HER2 Positive Breast Carcinoma
HER2/Neu Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: Lapatinib Ditosylate
Drug: Fulvestrant
Other: Placebo
Other: Laboratory Biomarker Analysis

  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
Between September 2006 and July 2010, 295 participants were recruited.

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 (Lapatinib) Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
Arm II (Placebo) Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.

Participant Flow:   Overall Study
    Arm I (Lapatinib)     Arm II (Placebo)  
STARTED     148     147  
COMPLETED     116     124  
NOT COMPLETED     32     23  
Adverse Event                 17                 3  
Withdrawal by Subject                 8                 8  
Alternate Treatment                 0                 1  
Other Medical Reasons                 7                 11  



  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.
Four (4) participants who never started treatment were excluded from all analyses

Reporting Groups
  Description
Arm I (Lapatinib) Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
Arm II (Placebo) Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
Total Total of all reporting groups

Baseline Measures
    Arm I (Lapatinib)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  146     145     291  
Age, Customized  
[units: participants]
     
<40     8     7     15  
40-49     21     17     38  
50-59     49     54     103  
60-69     41     47     88  
70+     27     20     47  
Gender  
[units: participants]
     
Female     146     145     291  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     7     14  
Not Hispanic or Latino     130     129     259  
Unknown or Not Reported     9     9     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     4     2     6  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     11     8     19  
White     127     132     259  
More than one race     0     2     2  
Unknown or Not Reported     3     1     4  
Region of Enrollment  
[units: participants]
     
United States     146     145     291  
Prior tamoxifen therapy  
[units: participants]
     
Yes     83     82     165  
No     63     63     126  
Bond disease only  
[units: participants]
     
Yes     45     43     88  
No     101     102     203  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years ]

2.  Secondary:   Objective Tumor Response Rate   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Study entry to death or last follow-up, up to 5 years ]

4.  Other Pre-specified:   Progression-free Survival for Participants With HER2-negative Tumors   [ Time Frame: Up to 5 years ]

5.  Other Pre-specified:   Progression-free Survival for Participants With HER2-positive Tumors   [ Time Frame: Up to 5 years ]

6.  Other Pre-specified:   Objective Tumor Response Rate for Participants With HER2-negative Tumors   [ Time Frame: Up to 5 years ]

7.  Other Pre-specified:   Objective Tumor Response Rate for Participants With HER2-positive Tumors   [ Time Frame: Up to 5 years ]


  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:  
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 more than 60 days but less than or equal to 180 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: Harold Burstein, M.D.
Organization: Dana-Farber Cancer Institue
e-mail: hburstein@partners.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390455     History of Changes
Other Study ID Numbers: NCI-2009-00475, NCI-2009-00475, CDR0000510452, CALGB-40302, CALGB 40302, CALGB-40302, U10CA180821, U10CA031946
Study First Received: October 18, 2006
Results First Received: June 1, 2015
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration