BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab BETH
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-064-08
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 34
• The patient must have given her consent to participate and must have signed and dated the two consent forms approved by the IRB that comply with the guidelines of the local regulatory authority and the institution. The consent form of the central HER2 evaluation prior to admission must be signed before the tumor material is sent to the central laboratory for HER2 evaluation.
• Patients must be female.
• The patient must be> 18 years of age. (The minimum age to be eligible may be over 18 years of age if required by the local regulatory authority).
• The patient must have an ECOG performance status of 0 or 1.
• The tumor must be an invasive unilateral mammary adenocarcinoma in histological examinations.
• Breast cancer must be positive for HER2 based on the test results as shown below: Local analysis (if available) must show that the tumor is IHC 2+ or 3+ or is believed to be positive for HER2 for gene amplification using FISH, CISH or another method of in situ hybridization. (If the results of the local IHS analyzes are considered ambiguous, the tumor may be sent for the central HER2 analysis to be performed). Central analysis (requirement for ALL patients) must show that the tumor is positive for HER2 which is defined as IHC 3+ and / or positive FISH.
• ER analyzes should be performed on patients in the primary tumor prior to randomization. In case the ER analysis is negative, the PgR analysis should also be performed.
• Patients must have undergone a total mastectomy or breast conservation surgery (nodulectomy)
• The interval between the last breast cancer surgery (treatment or stage) and the randomization should not be longer than 84 days or less than 28 days.
• In the case of patients who undergo a nodulectomy, the margins of the resected sample should not have histologically invasive tumor and DCIS established by the local pathologist. In case the pathological examination shows that there are tumors in the resection line, additional surgical procedures can be performed to obtain clear margins. In case the tumor is still present in the margin resected after the re-excision (s), the patient must undergo a total mastectomy to be eligible. (Patients with positive margins for LCIS are eligible without further resection).
• In the case of patients who undergo a mastectomy, the margins should not have larger residual tumors. Patients with positive microscopic margins are eligible.
• Patients must have completed one of the following procedures for the evaluation of lymph node disease: Sentinel lymphadenectomy followed by removal of non-sentinel lymph nodes, if N is positive; Sentinel lymphadenectomy only if pathological lymph node staging based on sentinel lymphadenectomy is pNo, pNimi or pNib; or axillary lymphadenectomy without SN isolation procedure.
• Patients with AST or alkaline phosphatase> ULN are eligible for inclusion in this study if the liver imaging (CT, MRI or PET scan), performed within 3 months prior to randomization, does not demonstrate a metastatic disease and meets with other analysis parameters described in Criterion 16 that appears below.
• Patients with alkaline phosphatase that is> ULN but <2.5 x ULN are eligible for inclusion in this study if the bone scan or PET scan, performed within 3 months prior to randomization, does not show a metastatic disease.
• Inflammatory breast cancer.
• Synchronous contralateral breast cancer (invasive or non-invasive).
• Definitive clinical or radiological evidence of metastatic disease. (Thoracic images [mandatory for all patients] and other images [if necessary] must have been made within 3 months prior to randomization)
• History of ipsilateral invasive breast cancer without taking into account treatment or ipsilateral DCIS treated with excision or RT.
• History of malignant non-breast tumors within 5 years prior to admission to the study, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basocellular or squamous cell carcinoma.
• Previous treatments with anthracycline, taxanes, carboplatin, trastuzumab or bevacizumab for any malignant tumor.
• Treatment that includes RT, chemotherapy and / or targeted treatment, administered for breast cancer currently diagnosed prior to randomization.
• Continuous treatment with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if the administration of these medications is discontinued prior to randomization).
• Heart disease (history of illness and / or active disease) that could prevent the use of the medicines included in the treatments.
• Uncontrolled hypertension defined as systolic BP> 150 mmHg or diastolic BP> 90 mmHg, with or without anti-hypertensive medications. (BP must be evaluated within 28 days prior to randomization). Patients with elevations of the initial BP are eligible, if the initiation or adjustment of BP medication decreases the pressure so that they meet the entry criteria.
• History of hypertensive crises or hypertensive encephalopathies.
• Antecedents of TIA or CVA.
• History of any arterial thrombotic event within 12 months prior to randomization.
• Symptomatic peripheral vascular disease.
• Intrinsic lung disease that causes dyspnea.
• Unstable diabetes mellitus.
• Active infection or chronic infection that requires suppressive antibiotics.
• Any significant bleeding within 6 months prior to randomization, excluding menorrhagia in pre-menopausal women.
• Hemorrhagic diathesis or known caogulopathies.
• Requirements for therapeutic doses of coumadin or equivalent.
• Active gastroduodenal ulcers documented by endoscopy within 6 months prior to randomization.
• History of GI perforation, abdominal fistulas or intra-abdominal abscesses.
• Unhealed wounds, ulcers on the skin or bone fracture incompletely healed.
• Important surgical procedure, open biopsies or major traumatic injuries within 28 days prior to the scheduled start of study treatment. (Note: placement of a vascular access device is not considered an important surgical procedure),
• Anticipation of the need for important surgical procedures during the treatment of the study and for at least 3 months after the end of bevacizumab.
• Conditions that may prohibit the administration of corticosteroids.
• Sensory / motor neuropathy> grade 2 as defined by the CTCAE v3.0 of the NCI.
• Other systemic diseases without malignant tumors that could prevent the patient from receiving study treatment or that could impede the necessary follow-up.
• Psychiatric or addictive disorders or other conditions that, depending on the investigator´s option, could prevent the patient from meeting the requirements of
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method