Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients (NCT01503905) | Clinical Trial Compass
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Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients
China600 participantsStarted 2011-12
Plain-language summary
The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. The patients signed the written informed consent.
✓. The patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
✓. The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy.
✓. The patients have normal cardiac functions by echocardiography.
✓. The patients' ECOG scores are ≤ 0-2.
✓. The age of patient is ≥ 18 years old; And the patients are premenopausal females.
✓. The patients are disposed to practice contraception during the whole trial.
✓. The results of patients' blood tests are as follows:
Exclusion criteria
✕. The patients have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
What they're measuring
1
Progression-free survival of patients.
Timeframe: within 10 years after diagnosis
2
Overall survival of the patients
Timeframe: within 10 years after diagnosis
Trial details
NCT IDNCT01503905
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University