Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early B… (NCT00022516) | Clinical Trial Compass
CompletedPhase 3
Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer
Australia1,086 participantsStarted 2000-11
Plain-language summary
This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed stage I, II, or III breast cancer
* T1-3, N0-2, M0
* Patients with sentinel node biopsy positive disease must have undergone axillary dissection
* Tumor must be confined to the breast without detected metastases elsewhere
* T4 disease with minimal dermal invasion allowed
* No T4 disease with ulceration of skin, infiltration of skin (except pathologically minimal dermal involvement), peau d'orange, or inflammatory breast cancer
* No bilateral breast cancer (except in situ carcinoma) or suspicious mass in opposite breast that has not been proven benign
* No distant metastases
* No skeletal pain of unknown cause, elevated alkaline phosphatase, or bone scan showing hot spots that cannot be ruled out as metastases by x-ray, MRI, and/or CT
* Must have undergone prior total mastectomy OR breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with negative margins) with radiotherapy planned
* Patients must begin or have begun an approved induction chemotherapy regimen within 8 weeks after definitive surgery
* Negative surgical margins
* Axillary clearance with at least 6 lymph nodes examined OR negative sentinel node biopsy
* Known HER2 status by immunohistochemistry or fluorescence in situ hybridization
* Hormone receptor status:
* Estrogen and progesterone receptor negative
* Less than 10% positive tumor cells by immunohistochemistry
PATIENT CHARACTERISTICS:
Age:
* No…
What they're measuring
1
Disease-free Survival
Timeframe: 5-year estimates, reported at a median follow-up of 6.9 years