Chemotherapy Adjuvant Study for women at advanced Age (CASA); Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a *Standard Chemotherapy Regimen*
- Conditions
- breast cancermammacarcinoma1000629110001474
- Registration Number
- NL-OMON31071
- Lead Sponsor
- International Breast Cancer Study Group (IBCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 35
- Women aged 66 years or older with histologically proven, resected breast cancer.
- Patients must not be candidates for endocrine therapy or standard chemotherapy regimen.
- Performance status (ECOG) 0-2.
- Patients must have endocrine nonresponsive tumors. (The recommended definition of endocrine nonresponsive: ER less than 10% of cells stained positive by immunohistochemical evaluation. If PgR is done, it should also be less than 10% of cells stained positive by immunohistochemical evaluation.)
- The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere.
- Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all tumors are endocrine nonresponsive.
- Patients must have had surgery for primary breast cancer (with or without axillary
clearance) with no known clinical residual loco-regional disease.
- Margins must be negative for invasive breast cancer and DCIS.
- Patients should be randomized and start treatment as close to definitive surgery as possible; within 6 weeks is recommended and not more than 16 weeks (from last surgery in case of bilateral breast cancer).
- Adequate bone marrow, renal, and hepatic function
- Adequate cardiovascular function
- Patients with locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary
nodes (unless pathologically negative).
- Patients with a history of any prior ipsilateral or contralateral invasive breast
cancer.
- Patients with previous or concomitant malignancy diagnosed within the past
five years. Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma are eligible regardless of the date of diagnosis.
- Patients with other non-malignant uncontrolled systemic diseases that would
preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV.
- Patients with myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomization.
- Patients with significant malabsorption syndrome or disease affecting gastrointestinal tract function.
- Patients with at least one of the so-called *geriatric syndromes*: dementia,
delirium, major depression (as diagnosed by a psychiatrist), recent falls, spontaneous bone fractures, neglect, and abuse.
- No hormone replacement therapy (HRT).
- No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is allowed prior to randomization.
- Raloxifene, tamoxifen, or other SERM must be discontinued at least 4 weeks before
randomization.
- No hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic.
- No treatment with bisphosphonates, except for the treatment of osteoporosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method