Trial Outcomes & Findings for An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer (NCT NCT01215123)

Last Updated: 2016-02-22

Results Overview

Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Target enrollment

28 participants

Primary outcome timeframe

Up to a maximum of 36.4 months

Results posted on

2016-02-22

Participant Flow

The study duration is January 2010 (first data collected) to July 2012 (last data collected). In this study, medical records of participants evaluated between 2008 and 2012 were reviewed.

Participant milestones

Participant milestones
Measure	Bevacizumab Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab n=28 Participants Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
Age, Continuous	54 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 36.4 months

Population: All enrolled participants

Outcome measures

Outcome measures
Measure	Bevacizumab n=28 Participants Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
Time to Disease Progression (TDP)	15.3 months Interval 2.6 to 36.4

SECONDARY outcome

Timeframe: Up to a maximum of 36.4 months

Population: All enrolled participants

Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.

Outcome measures

Outcome measures
Measure	Bevacizumab n=28 Participants Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
Treatment Duration: Number of Bevacizumab Cycles	6 cycles Interval 1.0 to 22.0

Adverse Events

Bevacizumab

Serious events: 10 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab n=28 participants at risk Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
General disorders Asthenia	17.9% 5/28 • Baseline up to 36.4 months All enrolled participants
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Skin and subcutaneous tissue disorders Alopecia	14.3% 4/28 • Baseline up to 36.4 months All enrolled participants

Other adverse events

Other adverse events
Measure	Bevacizumab n=28 participants at risk Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
General disorders Asthenia	39.3% 11/28 • Baseline up to 36.4 months All enrolled participants
General disorders Edemas	10.7% 3/28 • Baseline up to 36.4 months All enrolled participants
Cardiac disorders Cardiac event (not specified)	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Gastrointestinal disorders Nausea	17.9% 5/28 • Baseline up to 36.4 months All enrolled participants
Gastrointestinal disorders Vomits	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Gastrointestinal disorders Mucositis	14.3% 4/28 • Baseline up to 36.4 months All enrolled participants
Gastrointestinal disorders Diarrhea	14.3% 4/28 • Baseline up to 36.4 months All enrolled participants
Hepatobiliary disorders Liver event (not specified)	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Investigations Neutropenia	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Investigations Anemia	35.7% 10/28 • Baseline up to 36.4 months All enrolled participants
Musculoskeletal and connective tissue disorders Myalgias	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Musculoskeletal and connective tissue disorders Arthralgias	10.7% 3/28 • Baseline up to 36.4 months All enrolled participants
Nervous system disorders Neuropathy	10.7% 3/28 • Baseline up to 36.4 months All enrolled participants
Skin and subcutaneous tissue disorders Alopecia	21.4% 6/28 • Baseline up to 36.4 months All enrolled participants
Skin and subcutaneous tissue disorders Hand-foot syndrome	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants
Immune system disorders Allergy	7.1% 2/28 • Baseline up to 36.4 months All enrolled participants

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

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