Status:
UNKNOWN
Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy in Breast Cancer With Brain Metastases
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Breast Cancer
Brain Metastases
Eligibility:
FEMALE
20-75 years
Phase:
PHASE2
Brief Summary
The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (W...
Detailed Description
Brain metastasis (BM) occurs in about 20% to 35% of metastatic breast cancer (MBC) patients. In contrast to recent advances in systemic treatment of MBC, there is much room for improvement in treatmen...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A histological confirmed invasive breast cancer.
- At least one measurable brain metastatic tumor. If the measurable brain lesion has previously received stereotactic radiosurgery, the tumor must be a progressive lesion after radiosurgery.
- Patients who had not received WBRT.
- Patients with HER2/neu overexpression or amplification and had received trastuzumab before the diagnosis of BM will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
- Karnofsky performance score (KPS) higher or equal to 30%.
- Patients must have adequate organ function and marrow reserve measured within 14 days prior to randomization
- Age 20 to 75 years.
- Patient's life expectancy is more than 3 months.
- All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.
- Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.
- Patients (or a surrogate) must be able to comply with study procedures and sign informed consent.
- Exclusion criteria:
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
- Patients who have history of disease progression or disease developed during prior cisplatin treatment.
- Patients who had leptomeningeal metastasis, either diagnosed by brain imaging study or confirmed by cerebrospinal fluid cytology examination.
- Patients who are eligible for and willing to receive brain surgery or stereotactic radiosurgery (SRS) as the initial treatment of BM.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- History of thrombotic disorders.
- Active gastrointestinal bleeding.
- Patients with a history of self-reported intra-cranial hemorrhage or evidence of bleeding in previous cranial imaging.
- Patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of first dose of bevacizumab.
- Clinically significant peripheral artery occlusive disease.
- Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction.
- History of gross hemoptysis (e.g., ≥ 1 teaspoon of bright red blood).
- Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
- Psychiatric illness or social situation that would preclude study compliance.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.
- Prior minor surgery within 7 days.
- Concurrent chronic daily aspirin (\> 325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non-steroidal anti-inflammatory agents known to inhibit platelet function.
- Concurrent therapeutic anticoagulation, but prophylactic anti-coagulation of venous access devices is allowed.
- History of allergic reaction to compounds of similar chemical composition to the study drugs.
- Pregnancy or lactation.
Exclusion
Key Trial Info
Start Date :
April 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02185352
Start Date
April 21 2014
End Date
November 1 2022
Last Update
May 7 2021
Active Locations (8)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
2
Shuang Ho Hospital
New Taipei City, Taiwan
3
China Medical University Hospital
Taichung, Taiwan
4
National Taiwan University Hospital
Taipei, Taiwan, 100