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Standard Versus Continuous Capecitabine in Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00418028
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Complexo Hospitalario Universitario de A Coruña
Information provided by (Responsible Party):
Miguel Martin, Hospital San Carlos, Madrid

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Capecitabine
Drug: capecitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 2004 and August 2010, 195 patients were randomly assigned to Cint (97) and Ccont (98) in 13 GEICAM sites in Spain.

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 A (Cint)

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Arm B (Ccont)

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.


Participant Flow:   Overall Study
    Arm A (Cint)   Arm B (Ccont)
STARTED   97   98 
COMPLETED   95   97 
NOT COMPLETED   2   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
Arm A (Cint)

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Arm B (Ccont)

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Total Total of all reporting groups

Baseline Measures
   Arm A (Cint)   Arm B (Ccont)   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   98   195 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      55  56.7%      65  66.3%      120  61.5% 
>=65 years      42  43.3%      33  33.7%      75  38.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.07  (13.21)   58.59  (11.66)   59.82  (12.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      97 100.0%      98 100.0%      195 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Spain   97   98   195 


  Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: After 1 year from the treatment start day. ]

2.  Secondary:   Response Rate   [ Time Frame: Every 3 cycles and at the end of chemotherapy ]

3.  Secondary:   Response Duration   [ Time Frame: Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first. ]

4.  Secondary:   Time to Treatment Failure   [ Time Frame: Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient’s decision or investigator criteria. ]

5.  Secondary:   Overall Survival   [ Time Frame: Time to survival is the number of months from the study treatment start date to the date of death. ]

6.  Secondary:   Clinical Benefit   [ Time Frame: Months from “CR”,“PR” or “SD” (the first one) until Progression date, new treatment or last contact date. ]

7.  Secondary:   Progression Free Survival   [ Time Frame: Time (in months) from the moment the patient starts the study treatment to the date of progressive disease. ]


  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: The Oncologist 2015;20:1-2 http://www.theoncologist.com/ Scientific Director and CEO
Organization: GEICAM (Grupo Español de Investigación en Cancer de Mama)
phone: +34916592870
e-mail: geicam@geicam.org


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

Responsible Party: Miguel Martin, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT00418028     History of Changes
Other Study ID Numbers: 05/237
2004-002759-15 ( EudraCT Number )
First Submitted: January 3, 2007
First Posted: January 4, 2007
Results First Submitted: January 9, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017