A Randomized Phase II Study of Maintenance Hormone Therapy with or without Capecitabine after Induction Chemotherapy with Bevacizumab plus Paclitaxel in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer (KBCSG-TR1214)

Phase 2

• Conditions: Breast cancer

• Registration Number: JPRN-UMIN000008662
• Lead Sponsor: KBCSG-TR(Kinki Breast Cancer Study Group-TR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-09
• Study Completion: 2018-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Prior therapy with bevacizumab (2)Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, chinese hamster ovary cell derived products or other recombinant humanized antibodies (3)Hypersensitivity to capecitabine or fluoropyrimidines (4)Clinically or radiographically confirmed brain metastases (5)Treated brain metastasis within 3 months prior to registration (6)Women who is pregnant, lactating or declined contraception (7)Obvious infection or inflammation (with fever >= degrees centigrade (8)Active hepatitis (9)Patients with a nonhealing wound or fracture. (10)Massive pleural effusion, ascites or cardiac effusion (11)Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg). (12)Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study (13)Under coutinuous corticosteroid administration. (14)Symptomatic congestive heart failure,unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry. (15)Idiopathic pulmonary fibrosis, interstitial lung disease (16)Current or previous history (within 12 months) of symptomatic cerebrovascular disease (17)Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism. (18)Current or previous history (within 12 months) of GI perforation (19)Active peptic ulcer (20)Planned surgery within study term (21)Synchronous or metachronous tumors with <5 years disease-free period (22)Symptomtic peripheral neuropathy with functional disorders. (23)Patients ineligible to the study based on decision of attending physician or site principal investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified