Neoadjuvant Chemotherapy for Operable Premenopausal Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    600
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 21 January 2021

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.

Details
Condition Breast Cancer Nos Premenopausal
Treatment radiation therapy, cyclophosphamide, docetaxel, Epirubicin, Modified radical mastectomy or breast-conserving Surgery, Docetaxel (post-operative), Epirubicin (post-operative), Cyclophosphamide (post-operative), Herceptin (post-operative), Tamoxifen (post-operative)
Clinical Study IdentifierNCT01503905
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
Hb 90 g/L
WBC 4.0109/L
Plt 100109/L
Neutrophils 1.5109/L
ALT and AST triple of normal upper limit
TBIL 1.5 times of normal upper limit
Creatinine 1.25 times of normal upper limit

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
The patients have active infections that were not suitable for chemotherapy
The patients have severe non-cancerous diseases
The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails
The patients whose breast cancers are HER2 positive and choose to undergo the neoadjuvant chemotherapy that includes herceptin regimen
The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial
The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish
The patients have allergic history of the chemotherapeutic agents
The patients have bilateral breast cancers
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