apatinib and vinorelbine in women with previously treated breast cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer; breast cancer; Cancer - Breast

• Registration Number: ACTRN12610000347066
• Lead Sponsor: Breast Cancer Research Centre of WA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Study Completion: 2012-10-03
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

Electrocardiogram (ECG) with QTc interval less than or equal to 480 msecs .

Exclusion Criteria

Subjects meeting any of the following History of allergic or hypersensitivity reactions to either study drug (or related compounds) or their excipients.
Females who are pregnant or continuing to breast-feed.
Subjects who have received more than 2 different types of treatment with a Her2/neu targeted therapy for metastatic breast cancer
Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior anti-cancer therapy that would, in the investigators judgment, make the subject inappropriate for this study .
Any serious psychiatric disorder, dementia or altered mental status that would interfere with the subject’s safety or compliance to the study procedures.
GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn’s, ulcerative colitis).
Current active hepatic or biliary disease (with exception of subjects with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Active cardiac disease
Concurrent therapy given to treat cancer including treatment with hormonal therapy, an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
Neuropathy = grade 2 at baseline
Subjects previously treated with any vinorelbine or capecitabine (other than with lapatinib)
Subjects cannot have received any other chemotherapy agent concurrent with trastuzumab and the taxane apart from the inclusion of a platinum agent in the first HER2/neu targeted regimen used in the metastatic setting .
Prior treatment with anthracyclines with a cumulative dose of doxorubicin > 400 mg/m2 or epirubicin >800mg /m2 or equivalent dose for other anthracyclines derivatives .
Subjects who have concurrent active infections requiring IV antibiotics or non-healing wound.

Study & Design

• Study Type: Interventional
• Study Design: Not specified