Trial Outcomes & Findings for XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer (NCT NCT01777945)

NCT ID: NCT01777945

Last Updated: 2016-08-19

Results Overview

The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.

• Recruitment status: COMPLETED
• Target enrollment: 46 participants
• Primary outcome timeframe: approximately 2 years
• Results posted on: 2016-08-19

Participant Flow

46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.

Participant milestones

Measure	Participants Receiving Capecitabine/Docetaxel Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Study STARTED	46
Overall Study Evaluable Participants	45
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	58.58 years STANDARD_DEVIATION 11.359 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Hungary	45 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 2 years

The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Progression-free Survival (PFS)	9.89 months Standard Deviation 2.97

SECONDARY outcome

Timeframe: approximately 2 years

The time from enrollment to discontinuation of any drug of the treatment combination.

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Time to Treatment Failure	4.64 months Standard Deviation 5.14

SECONDARY outcome

Timeframe: approximately 2 years

The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Response Rate	28.9 percentage of participants

SECONDARY outcome

Timeframe: approximately 2 years

The percentage of participants with an overall response (complete or partial remission) or with stable disease.

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Clinical Benefit Rate	73.3 percentage of participants

SECONDARY outcome

Timeframe: approximately 2 years

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Duration of Treatment With Xeloda	6.24 treatment cycle Standard Deviation 4.80

SECONDARY outcome

Timeframe: approximately 2 years

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=45 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Percentage of Capecitabine Dose Modifications	44.4 percentage of doses

SECONDARY outcome

Timeframe: approximately 2 years

Population: 46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.

Outcome measures

Measure	Participants Receiving Capecitabine/Docetaxel n=46 Participants Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Number of Participants With Adverse Events	33 participants

Adverse Events

Participants Receiving Capecitabine/Docetaxel

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants Receiving Capecitabine/Docetaxel n=46 participants at risk Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Blood and lymphatic system disorders Anemia	2.2% 1/46 • Number of events 1
Blood and lymphatic system disorders Neutropenia	6.5% 3/46 • Number of events 3
Blood and lymphatic system disorders Thrombocytopenia	2.2% 1/46 • Number of events 1
Cardiac disorders Heart Failure	2.2% 1/46 • Number of events 1
Gastrointestinal disorders Diarrhea	2.2% 1/46 • Number of events 1
General disorders Disease Progression	6.5% 3/46 • Number of events 3
General disorders Mucositis	2.2% 1/46 • Number of events 1
Infections and infestations Pneumonia	2.2% 1/46 • Number of events 1
Skin and subcutaneous tissue disorders Dermatitis	2.2% 1/46 • Number of events 1

Other adverse events

Measure	Participants Receiving Capecitabine/Docetaxel n=46 participants at risk Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Blood and lymphatic system disorders Neutropenia	21.7% 10/46 • Number of events 14
Gastrointestinal disorders Diarrhea	6.5% 3/46 • Number of events 4
General disorders Mucositis	8.7% 4/46 • Number of events 4
Skin and subcutaneous tissue disorders Palmoplantar erythrodysesthesia syndrome	26.1% 12/46 • Number of events 13

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER