Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy in Breast Cancer With Brain Metastases

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02185352
• Date of registration: 25/06/2014
• Prospective Registration: No
• Primary sponsor: National Taiwan University Hospital
• Public title: Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy in Breast Cancer With Brain Metastases A-Plus
• Scientific title: Randomized Phase II Study of Induction Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy (WBRT) Versus WBRT Alone in Breast Cancer With Untreated Brain Metastases
• Date of first enrolment: April 21, 2014
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02185352
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Taiwan

Contacts

• Name: Yen-Shen Lu, M.D, Ph.D.
• Affiliation: National Taiwan Unversity Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Brain Metastases

Breast Cancer

Intervention(s)

Drug: BEEP regimen

Primary Outcome(s)

The Brain-specific progression free survival (BS-PFS) [Time Frame: 2.5 years]

Secondary Outcome(s)

The 2-month brain-specific objective response rate (BS-ORR) [Time Frame: 2 months]

Secondary ID(s)

201402059MIPD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors