A Phase III randomized study evaluating the efficacy and safety of continued and re-induced bevacizumab in combination with chemotherapy for patients with locally recurrent or metastatic breast cancer after first-line chemotherapy and bevacizumab treatment. - TANIA

• Conditions: ocally recurrent (LR) or metastatic breast cancer (mBC) progressing after first-line chemotherapy and bevacizumab treatment.; MedDRA version: 12.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2010-020998-16-GR
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-10
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 488

Inclusion Criteria

1. Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patient’s awareness and willingness to comply with the study requirements
2. Female patients =18 years of age
3. Histologically confirmed HER2-negative adenocarcinoma of the breast with documented progression of disease per investigator assessment following or during first-line treatment with bevacizumab in combination with chemotherapy for LR or mBC; patients can have measurable or non-measurable disease.
4. A minimum of 4 cycles of bevacizumab 15 mg/kg or 6 cycles 10 mg/kg received in the first-line setting. Note: patients who have received bevacizumab treatment as part of (neo-) adjuvant therapy are eligible but these bevacizumab cycles do not count towards the minimum required number of cycles.
5. Patients must have received bevacizumab in combination with chemotherapy. Patients may have received:
• Bevacizumab monotherapy
• Bevacizumab in combination with endocrine treatment
• Endocrine treatment
• Nothing
as part of their maintenance treatment.
6. ECOG performance status (PS) of 0 or 2
7. At least 28 days since prior radiation therapy or surgery and recovery from treatment
8. Estimated life expectancy of =12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease-specific exclusions
1. Patients who have received anti-angiogenic therapy or anti-vascular endothelial growth factors other than bevacizumab for the first-line treatment of LR/mBC
2. Patients who have exclusively received endocrine treatment in combination with bevacizumab until the first progression
3. Positive or unknown HER2/neu status or for whom determination of HER2 status is not possible. In general, HER2-positive status will be identified by a FISH assay as evaluated at the institution, or, if FISH is unavailable, a 2+ or 3+ immunohistochemistry result.
4. Current, recent or planned participation in an experimental drug study - other than a bevacizumab breast cancer study.
5. Active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix or breast within the last 5 years
6. Any laboratory values at baseline as follows:
Hematology:
ANC <1.5x10E9/L or 1500/mm3
Platelet count <75x10E9/L
Hemoglobin <8 g/dL
Coagulation:
INR >1.5 except for patients on stable anticoagulant therapy
aPTT =1.5 times ULN or greater than the lower limit of the therapeutic range
Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of Day 1,
Cycle 1.
Serum chemistry:
Total bilirubin >1.5 times ULN
AST or ALT >2 times ULN
ALP >2 times ULN
7. Inadequate renal function, defined as:
Creatinine clearance <50 mL/min
Urine dipstick for proteinuria =2+ unless a 24-hour protein =1 g is demonstrated
8. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements
9. Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry
10. Patients who are treated with any medicinal product that contraindicates the use of any of the study drugs, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications
Bevacizumab-specific exclusions
11. Inadequately controlled hypertension while receiving anti-hypertensive medication
12. Prior history of hypertensive crisis or hypertensive encephalopathy
13. Prior history of nephrotic syndrome
14. New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF). Note: For those patients where it is indicated an ECHO/MUGA must be performed. The LVEF must be above the institutional lower limit of normal in order for the patient to be eligible.
15. History of myocardial infarction or unstable angina within 6 months prior to day 1
16. History of stroke or transient ischemic attack (TIA) within 6 months prior to day 1
17. Known CNS disease, except for treated brain metastases. Treated brain metastases are defined as: having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging during the screening period. Anticonvulsants are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to day 1 are excluded. A brain or MRI scan is required within 28 days prior to day 1 if the pr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified